business plan clinical trials

Clinical Research Company Business Plan [Sample Template]

By: Author Tony Martins Ajaero

Home » Business ideas » Healthcare and Medical » Clinical Research

Are you about starting a clinical research company? If YES, here is a complete sample clinical research business plan template & feasibility report you can use for FREE .

Okay, so we have considered all the requirements for starting a clinical research company. We also took it further by analyzing and drafting a sample clinical research marketing plan template backed up by actionable guerrilla marketing ideas for clinical research businesses. So let’s proceed to the business planning section.

Clinical research business is gaining grounds not only in the united states of America but in all parts of the world, hence new frontiers have been achieved in the healthcare cum medical industry.

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Good enough, the clinical research line of business is open to aspiring entrepreneurs who have the required qualifications and experience to run such business.

This industry is highly profitable even though your level of profitability is dependent on your ability to come up with breakthrough clinical research works in the healthcare cum medical industry such as pharmaceutical companies, biotechnology companies, biomedical companies, ministry of health, hospitals, medical clinics, medical devices development companies and other key stakeholders in the United States of America.

As such, if you have decided to start your own clinical research company, then you should ensure that you carry out thorough feasibility studies and market survey.

Business plan is yet another very important business document that you should not take for granted when launching your own clinical research business.

Below is a sample clinical research company business plan template that can help you to successfully write your own with little or no difficulty.

A Sample Clinical Research Business Plan Template

1. industry overview.

The Contract Research Organizations industry that clinical research business is a subset of, is perhaps one of the fastest growing and largest industries in the world. Obviously, there is hardly any country where the healthcare and medical industry is not handled with all seriousness.

As a matter of fact, the healthcare industry cum Contract Research industry is known to gulp over 10 percent of gross domestic product (GDP) of most developed countries.

The Contract Research Organizations industry includes companies that provide research services on a contract basis to the pharmaceutical and biotechnology industries.

Contract research organizations (CRO) provide biopharmaceutical development, preclinical research, clinical research and clinical trial management. Many CROs specifically provide clinical study and trial support for drugs or medical devices.

A recent report published by IBISWorld shows that the Contract Research Organizations Industry is indeed experiencing rapid growth. The report shows that over the past five years, demand for industry services has risen as clients increasingly use their research and development (R&D) budgets to outsource to CROs.

As a result, industry revenue is expected to grow at an annualized rate of 7.1 percent to $17.1 billion in the five years to 2016, which includes 6.3 percent projected growth in 2016 alone.

The industry experienced a period of aggressive growth over the past five years, benefiting from an aging US population and an expansion in private health-related research and development (R&D) expenditures. As a result, industry revenue is expected to grow in the five years to 2016.

Over the next five years, the industry will continue to benefit from increased R&D spending and an aging US population. The industry will also benefit from rising demand from biopharmaceutical companies. IBISWorld forecasts that industry revenue will increase over the five years to 2022.

The Contract Research Organizations industry that clinic research company is a part of is indeed a very massive industry in Germany, united kingdom, Switzerland, China, Japan, India and the United States of America. Statistics have it that in the United States of America, the industry is worth $17bn, with an estimated growth rate of 7.1 percent.

There are about 3,585 registered and licensed contract research organizations cum clinical research businesses in the United States and they are responsible for employing about 5,513,669 people. LabCorp and Quintiles are the leaders in this industry and they can boast of having the lion shares of the available market in the United States.

If you are considering starting your own clinical research company in the United States, then you should try and work around the industry barriers. The truth is that the barriers to entry in the contract research organizations industry are high due to the significant regulatory requirements.

Some of the factors that encourage entrepreneurs to start their own clinical research business could be that the business can easily get support from the government at all level and the business is indeed a profitable venture despite the legislature governing the industry.

Over and above, if you are determined and you are ready to go all the way, you will surely succeed in establishing your own clinical research company in the United States of America and you will be glad you did because it is indeed a profitable line of business.

2. Executive Summary

Dennis Landers® Clinical Research Company, Inc. is a standard, licensed and government approved clinical research cum contract research organization that will be located in the heart of Concord – New Hampshire. We have been able to acquire a standard corner-piece facility that is highly suitable for the kind of clinical research business we want to operate.

Dennis Landers® Clinical Research Company, Inc. is in the contract research industry to provide several services for clients in the pharmaceutical, biotechnology and medical device sectors. We will conduct clinical trials and research, manage data results, provide regulation adherence services and help develop and formulate new products for our clients.

We are geared towards providing our clients with cost savings, accelerated development timelines and reduced risk through their service offerings. We are well trained and equipped to service the market segments that require the services we will be offering.

We are in the clinical research line of business to deliver excellent result oriented research services to all those who will patronize us.

We will also ensure that in the line of carrying out our duty, we comply with the laws and health regulations in New Hampshire and the United States of America. Our employees are well trained and qualified to handle the wide range of clinical research services.

At Dennis Landers® Clinical Research Company, Inc., our clients’ overall best interest would always come first, and everything we do is guided by our values and professional ethics. We will ensure that we hire professional and certified clinic researchers with various skill sets who are well experienced and passionate in helping our clients achieve their goals within record time.

Dennis Landers® Clinical Research Company, Inc. will at all times demonstrates her commitment to sustainability, both individually and as a nutrition consulting firm , by actively participating in our communities and integrating sustainable business practices wherever possible.

We will ensure that we hold ourselves accountable to the highest standards by meeting our clients’ needs precisely and completely.

Dennis Landers® Clinical Research Company, Inc. is a family business that is owned and managed by Dr. Dennis Landers (PhD) and his immediate family members. Dr. Dennis Landers is going to be the Chief Researcher of the organization.

He is a qualified and well trained Clinical Researcher with over 15 years’ experience working as an associate professor and medical researcher with the University of Michigan.

3. Our Products and Services

Dennis Landers® Clinical Research Company, Inc. is in the clinical research line of business to offer varieties of services within the scope of the contract research organizations industry in the United States of America.

Our intention of starting our clinical research company is to become one of the leading brands in the industry and of course to also make profits and we will do all that is permitted by the law in the US to achieve our aim and business goal. These are the clinical research services that Dennis Landers® Clinical Research Company, Inc. will be offering;

• Performing clinical research for pharmaceutical, biomedical and biotechnology companies
• Performing clinical research for medical device manufacturers
• Data management and regulation adherence services
• Development, advancement and formulation of devices and medications

4. Our Mission and Vision Statement

• Our vision is to become the number one choice when it comes to clinical research in the whole of New Hampshire and also to be amongst the top 10 clinical research companies cum contract research organizations in the United States of America within the next 10 years.
• Dennis Landers® Clinical Research Company, Inc. is in business is to establish a first –  class clinical research company that will be known for coming up with ground breaking researches and solutions for our clients. We want to become one of the leaders in the contract research organizations industry in New Hampshire, and in the United States of America.

Our Business Structure

Dennis Landers® Clinical Research Company, Inc. is a business that will be built on solid foundation. From the outset, we have decided to recruit only qualified professionals (researchers) to man various job positions in our organization.

We are quite aware of the rules and regulations governing the contract research industry which is why we decided to recruit only well experienced and qualified employees as foundational staff of the organization. We hope to leverage on their expertise to build our clinical research business brand to be well accepted in Concord – New Hampshire and the whole of the United States.

When hiring, we will look out for applicants that are not just qualified and experienced, but honest, customer centric and are ready to work to help us build a prosperous business that will benefit all our stake holders.

As a matter of fact, profit-sharing arrangement will be made available to all our management staff and it will be based on their performance for a period of five years or more. In view of the above, we have decided to hire qualified and competent hands to occupy the following positions;

• Chief Researcher / Chief Executive Officer
• Clinical Research Fellows

Office Administrator

• Marketing Executives

Client Service Executive

5. Job Roles and Responsibilities

Chief Researcher/Chief Executive Officer:

• Creates, interconnects, and implements the organization’s vision, mission, and overall direction – i.e. leading the development and implementation of the overall organization’s strategy.
• Accountable for fixing prices and signing business deals
• Responsible for providing direction for the business
• Responsible for signing checks and documents on behalf of the company
• Evaluates the success of the organization

Clinical Research Fellow

• Performs clinical research for pharmaceutical, biomedical and biotechnology companies
• Performs clinical research for medical device manufacturers
• Handles data management and regulation adherence services
• In control of development, advancement and formulation of devices and medications
• Keeps up with the latest clinical science research
• Responsible for overseeing the smooth running of HR and administrative tasks for the organization
• Designs job descriptions with KPI to drive performance management for psychologists, social workers and marriage counselors
• Regularly hold meetings with key stakeholders to review the effectiveness of the organizations’ Policies, Procedures and Processes
• Maintains office supplies by checking stocks; placing and expediting orders; evaluating new products.
• Ensures operation of equipment by completing preventive maintenance requirements; calling for repairs.
• Defines job positions for recruitment and managing interviewing process
• Carries out induction for new team members
• Responsible for training, evaluation and assessment of employees
• Responsible for arranging travel, meetings and appointments
• Oversees the smooth running of the daily activities for the organization.

Marketing Executive

• Identifies, prioritizes, and reaches out to new clients, and business opportunities et al
• Identifies development opportunities; follows up on development leads and contacts; participates in the structuring and financing of projects; assures the completion of development projects.
• Writes winning proposal documents, negotiate fees and rates in line with organizations’ policy
• Responsible for handling business research, market surveys and feasibility studies for clients
• Responsible for supervising implementation, advocate for the customer’s needs, and communicate with clients
• Develops, executes and evaluates new plans for expanding sales
• Documents all customer contact and information
• Represents the organization in strategic meetings
• Help increase sales and growth for the organization
• Responsible for preparing financial reports, budgets, and financial statements for the organization
• Provides managements with financial analyses, development budgets, and accounting reports; analyzes financial feasibility for the most complex proposed projects; conducts market research to forecast trends and business conditions.
• Responsible for financial forecasting and risks analysis.
• Performs cash management, general ledger accounting, and financial reporting for one or more properties.
• Responsible for developing and managing financial systems and policies
• Responsible for administering payrolls
• Ensuring compliance with taxation legislation
• Handles all financial transactions for the organization
• Serves as internal auditor for the organization.
• Welcomes clients and visitors by greeting them in person or on the telephone; answering or directing inquiries.
• Ensures that all contacts with clients (e-mail, walk-In center, SMS or phone) provides the client with a personalized customer service experience of the highest level
• Through interaction with clients on the phone, uses every opportunity to build client’s interest in the company’s products and services
• Manages administrative duties assigned by the principal partners in an effective and timely manner.
• Consistently stays abreast of any new information on the organizations’ products, promotional campaigns etc. to ensure accurate and helpful information are supplied to clients when they make enquiries.
• Receives parcels/documents for the organization.

6. SWOT Analysis

Dennis Landers® Clinical Research Company, Inc. is set to become one of the leading clinical research companies in New Hampshire which is why we are willing to take our time to cross every ‘Ts’ and dot every ‘Is’ as it relates to our business.

We want our clinical research company to be the number one choice of all medical organizations and pharmaceutical companies in the whole of New Hampshire. We know that if we are going to achieve the goals that we have set for our business, then we must ensure that we build our business on a solid foundation. We must ensure that we follow due process in setting up the business.

Even though our Chief Researcher has a robust experience in clinical and medical research, we still went ahead to hire the services of business consultants that are specialized in setting up new businesses to help our organization conduct detailed SWOT analysis.

This is the summary of the SWOT analysis that was conducted for Dennis Landers® Clinical Research Company, Inc.;

Our core strength lies in our ability to attract local support and frequent referrals, having a high prior success rate and recommendation/accreditation from authoritative source. We have a team that are considered experts in the industry, a team with excellent qualifications and experience in the contract research industry.

Aside from the synergy that exists in our carefully selected team members and our strong online presence, Dennis Landers® Clinical Research Company, Inc. is well positioned in a community with the right demography and we know we will attract loads of clients from the first day we open our doors for business.

As a new clinical research company in Concord – New Hampshire, it might take some time for our organization to break into the market and gain acceptance especially from top profile clients in the fast – growing contract research organizations industry; that is perhaps our major weakness.

• Opportunities:

The opportunities that are available to clinical research companies are unlimited considering the fact that the healthcare industry is a dynamic industry. The cost of developing drugs and medical devices has skyrocketed in recent time, forcing pharma companies to look for innovations and smarter ways of doing business.

The fact that the industry will continue to benefit from increased R&D spending and the expansion of the biomedical field is likely to play an important role in the success of CROs and will indeed open more opportunities for players in this industry.

Just like any other business, one of the major threats that we are likely going to face is economic downturn and unfavorable government policies (slowdown in releasing funding for Research and Development organization). As a matter of fact, the growth of a few dominant operators has led to an increasing level of concentration.

7. MARKET ANALYSIS

• Market Trends

One notable trend in the clinical research industry is merger and acquisition. As a matter of fact, there will be more mergers and acquisitions of pharma and biopharma companies.

If you are a close observer of the clinical research industry, you will notice that Chiltern has acquired Theorem and Actavis completing the acquisition of Allergan and Forest Labs. According to law firm Reed Smith, 94 percent of senior executives at life science companies are planning to make an acquisition in 2016.

The survey also found that a focus on personalized medicine will continue to shape the industry, with high returns on investment even though patient populations are smaller.

As part of this program, FDA is holding a series of public meetings on specific disease areas, including, breast cancer, sickle cell disease, psoriasis and autism. The continuing focus of the program is to empower patients into helping to shape their treatment.

Lastly, data and technology will help to optimize clinical trials. New technology including apps, wearable sensors and online systems will help to improve data quality, whilst online platforms capturing patient insights will help to provide input into trial design focused on improving patient experience.

8. Our Target Market

Dennis Landers® Clinical Research Company, Inc. is in business to service a wide range of customers in Concord – New Hampshire and all across the United States of America. We will ensure that we target both private companies and government organizations.

The fact that we are going to open our doors to a wide range of customers does not in any way stop us from abiding by the rules and regulations governing the clinical research industry in the United States. Our staff are well – trained to effectively service our customers and give them value for their monies.

Our customers can be categorized into the following;

• Pharmaceutical companies
• Biotechnology companies
• Biomedical companies
• Ministry of Health
• Hospitals and medical clinics
• Medical devices development companies

Our Competitive Advantage

Aside from the competitions that exist amongst various clinic research organizations, they also compete against universities and government agencies that are also into clinical research.

To be highly competitive in the clinical research industry means that you should be able to provide ground breaking research and provide solutions at all times.

Dennis Landers® Clinical Research Company, Inc. is coming into the market well prepared to favorably compete in the industry. We will ensure our pricing policy is appropriate, plus the fact that we will have a good reputation and also economies of scale.

Our staff are well groomed in all aspects of clinic research and all our employees are trained to provide customized customer service to all our clients. Our services will be carried out by highly trained professionals who know what it takes to give our highly esteemed customers value for their money.

Lastly, all our employees will be well taken care of, and their welfare package will be among the best within our category in the industry. It will enable them to be more than willing to build the business with us and help deliver our set goals and objectives.

9. SALES AND MARKETING STRATEGY

• Sources of Income

Dennis Landers® Clinical Research Company, Inc. will ensure that we do all we can to maximize the business by generating income from every legal means within the scope of our industry. Below are the sources we intend exploring to generate income for Dennis Landers® Clinical Research Company, Inc.;

10. Sales Forecast

One thing is certain, there would always be pharmaceutical companies, biomedical companies and biotechnology companies who would need the services of clinical research companies to help them produce efficient and reliable drugs and medical instrument et al. This is the major reason why the services of clinical research companies will always be needed.

We are well positioned to take on the available market in Concord – New Hampshire and we are quite optimistic that we will meet our set target of generating enough profits from the first six months of operation and grow our clinical research business and our clientele base.

We have been able to critically examine the clinical research market, we have analyzed our chances in the industry and we have been able to come up with the following sales forecast. The sales projections are based on information gathered on the field and some assumptions that are peculiar to similar startups in Concord – New Hampshire.

Below are the sales projections for Dennis Landers® Clinical Research Company, Inc., it is based on the location of our clinical consulting firm and of course the wide range of clinic research services that we will be offering;

• First Fiscal Year: $350,000
• Second Fiscal Year: $750,000
• Third Fiscal Year: $1 million

N.B : This projection is done based on what is obtainable in the industry and with the assumption that there won’t be any major economic meltdown and there won’t be any major competitor offering same additional services as we do within same location. Please note that the above projection might be lower and at the same time it might be higher.

• Marketing Strategy and Sales Strategy

The marketing and sales strategy adopted by Dennis Landers® Clinical Research Company, Inc. will be based on generating long-term personalized relationships with customers. In order to achieve that, we will ensure that we offer top notch clinical research services at affordable prices compared to what is obtainable in and around Concord – New Hampshire.

All our employees will be well trained and equipped to provide excellent and knowledgeable clinical research services and customer service. We know that if we are consistent with offering high quality clinical research and excellent customer service, we will increase the number of our customers by more than 25 percent for the first year and then more than 40 percent subsequently.

Before choosing a location for our clinical research company, we conducted a thorough market survey and feasibility studies in order for us to penetrate the available market and become the preferred choice for organizations in Concord – New Hampshire and of course in other cities all across the United States of America.

We have detailed information and data that we were able to utilize to structure our business to attract the number of customers we want to attract per time.

We hired experts who have good understanding of the clinical research industry to help us develop marketing strategies that will help us achieve our business goal of winning a larger percentage of the available market in and around Concord – New Hampshire.

In summary, Dennis Landers® Clinical Research Company, Inc. will adopt the following sales and marketing approach to win customers over;

• Introduce our clinical research company by sending introductory letters to pharmaceutical companies, biotechnology companies, biomedical companies, ministry of health, hospitals, medical clinics, medical devices development companies and other key stakeholders in the United States of America
• Advertise our clinical research company in community based newspapers, local TV and radio stations
• List our clinical research organization on yellow pages’ ads (local directories)
• Leverage on the internet to promote our business
• Engage in direct marketing
• Leverage on word of mouth marketing (referrals)
• Enter into business partnership with health management organizations, government agencies and medical colleges / university teaching hospitals
• Attend clinical research related expos with the aim of networking and marketing our clinical research business

11. Publicity and Advertising Strategy

We are in the clinical research business to become one of the market leaders and also to maximize profits hence we are going to explore all available means to promote our company.

Dennis Landers® Clinical Research Company, Inc. has a long – term plan of working for clients all across the United States and other parts of the world which is why we will deliberately build our brand to be well accepted in Concord – New Hampshire before venturing out.

As a matter of fact, our publicity and advertising strategy is not solely for winning customers over but to effectively communicate our brand to the general public. Here are the platforms we intend leveraging on to promote and advertise Dennis Landers® Clinical Research Company, Inc.;

• Place adverts on both print (community based newspapers and magazines) and electronic media platforms
• Sponsor relevant community health and research programs
• Leverage on the internet and social media platforms like Instagram, Facebook, twitter, YouTube, Google + et al to promote our brand
• Install our billboards in strategic locations all around Concord – New Hampshire
• Engage in roadshow from time to time
• Distribute our fliers and handbills in target areas
• Ensure that all our workers wear our branded shirts and all our vehicles are well branded with our company’s logo et al.

12. Our Pricing Strategy

Generally, research services are billed on the results produced on a weekly or monthly basis as it applies. As a result of this, Dennis Landers® Clinical Research Company, Inc. will charge our clients flat fees except for few occasions where there will be need for us to charge special clients on hourly basis.

At Dennis Landers® Clinical Research Company, Inc. we will keep our fees below the average market rate by keeping our overhead low and by collecting payment in advance. In addition, we will also offer special discounted rates to all our clients at regular intervals.

• Payment Options

The payment policy adopted by Dennis Landers® Clinical Research Company, Inc. is all inclusive because we are quite aware that different customers prefer different payment options as it suits them but at the same time, we will ensure that we abide by the financial rules and regulation of the United States of America.

Here are the payment options that Dennis Landers® Clinical Research Company, Inc. will make available to her clients;

• Payment via bank transfer
• Payment with cash
• Payment via credit cards
• Payment via online bank transfer
• Payment via check
• Payment via mobile money transfer
• Payment via bank draft

In view of the above, we have chosen banking platforms that will enable our clients make payment for our services without any stress on their part. Our bank account numbers will be made available on our website and promotional materials to clients who may want to pay for services rendered.

13. Startup Expenditure (Budget)

If you are looking towards starting a clinical research organization, then you should go all out to ensure that you raise enough capital to cover some of the basic expenditure that you are going to incur. The truth is that starting this type of business does not come cheap.

You would need money to secure a standard facility, acquire medical equipment and supply , pay your workforce and pay bills for a while until the revenue you generate from the business becomes enough to pay them. The items listed below are the basics that we would need when starting our clinical research organization in the United States, although costs might vary slightly;

• The total fee for registering the Business in the United States – $750.
• Legal expenses for obtaining licenses and permits – $1,500.
• Marketing promotion expenses for the grand opening of Dennis Landers® Clinical Research Company, Inc. in the amount of $3,500 and as well as flyer printing (2,000 flyers at $0.04 per copy) for the total amount of – $3,580.
• Cost for hiring Business Consultant – $2,500.
• Cost for computer software (Accounting Software, Payroll Software, CRM Software, Microsoft Office, and QuickBooks Pro et al) – $7,000
• Insurance (general liability, workers’ compensation and property casualty) coverage at a total premium – $3,400.
• Cost for payment of rent for 12 months at $1.76 per square feet in the total amount of – $105,600.
• Cost for facility remodeling (construction of racks and shelves) – $20,000.
• Other start-up expenses including stationery ( $500 ) and phone and utility deposits – ( $2,500 ).
• Operational cost for the first 3 months (salaries of employees, payments of bills et al) – $500,000
• Cost for medical/lab equipment – $300,000
• The cost for the purchase of furniture and gadgets (Computers, Printers, Telephone, TVs, tables and chairs et al) – $4,000.
• The cost of launching a website – $700
• Miscellaneous – $10,000

We would need an estimate of five hundred thousand dollars ( $500,000 ) to successfully set up our clinical research business in Concord – New Hampshire.

Generating Startup Capital for Dennis Landers® Clinical Research Company, Inc.

Dennis Landers® Clinical Research Company, Inc. is a private clinical research business that will be owned and managed by Dr. Dennis Landers (PhD). and his immediate family members. They are the financiers of the business, but may likely welcome partners later which is why they decided to restrict the sourcing of the startup capital for the business to just three major sources.

These are the areas we intend generating our startup capital;

• Generate part of the startup capital from personal savings
• Source for soft loans from family members and friends
• Apply for loan from my Bank

N.B: We have been able to generate about $100,000 ( Personal savings $20,000 and soft loan from family members $80,000 ) and we are at the final stages of obtaining a loan facility of $400,000 from our bank. All the papers and documents have been duly signed and submitted, the loan has been approved and any moment from now our account will be credited.

14. Sustainability and Expansion Strategy

The future of a business lies in the number of loyal customers that they have, the capacity and competence of the employees, their investment strategy and the business structure. If all of these factors are missing from a business, then it won’t be too long before the business close shop.

One of our major goals of starting Dennis Landers® Clinical Research Company, Inc. is to build a business that will survive off its own cash flow without the need for injecting finance from external sources once the business is officially running.

We know that one of the ways of gaining approval and winning customers over is to offer our clinical research work a little bit cheaper than what is obtainable in the market and we are well prepared to survive on lower profit margin for a while.

Dennis Landers® Clinical Research Company, Inc. will make sure that the right foundation, structures and processes are put in place to ensure that our staff welfare are well taken of. Our organizations’ corporate culture is designed to drive our business to greater heights and training and retraining of our workforce is at the top burner.

As a matter of fact, profit-sharing arrangement will be made available to all our management staff and it will be based on their performance for a period of three years or more. We know that if that is put in place, we will be able to successfully hire and retain the best hands we can get in the industry; they will be more committed to help us build the business of our dreams.

Check List/Milestone

• Business Name Availability Check: Completed
• Business Registration: Completed
• Opening of Corporate Bank Accounts: Completed
• Securing Point of Sales (POS) Machines: Completed
• Opening Mobile Money Accounts: Completed
• Opening Online Payment Platforms: Completed
• Application and Obtaining Tax Payer’s ID: In Progress
• Application for business license and permit: Completed
• Purchase of Insurance for the Business: Completed
• Leasing of facility and remodeling the facility: In Progress
• Conducting Feasibility Studies: Completed
• Generating capital from family members: Completed
• Applications for loan from the bank: In Progress
• Writing of Business Plan: Completed
• Drafting of Employee’s Handbook: Completed
• Drafting of Contract Documents and other relevant Legal Documents: In Progress
• Design of The Company’s Logo: Completed
• Printing of Promotional Materials: In Progress
• Recruitment of employees: In Progress
• Purchase of Medical Equipment and Lab Equipment suitable for clinical research et al: In Progress
• Purchase of the needed furniture, racks, shelves, computers, electronic appliances, office appliances and CCTV: In progress
• Creating Official Website for the Company: In Progress
• Creating Awareness for the business both online and around the community: In Progress
• Health and Safety and Fire Safety Arrangement (License): Secured
• Opening party planning: In Progress
• Compilation of a list of clinic research areas that will be our strong emphasis: Completed
• Establishing business relationship with pharmaceutical companies, biotechnology companies, biomedical companies, ministry of health, hospitals and medical clinics and medical devices development companies and other key stakeholders in the United States of America: In Progress.

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4. Financial Projections

Develop comprehensive financial projections to demonstrate the viability and profitability of your clinical trial business. Calculate your projected revenue, expenses, and profit margins based on your market research and business model. Include details on funding sources, such as grants or investor capital, and outline your financial goals for the next few years.

Use the Dashboards feature in ClickUp to create visual representations of your financial projections, making it easier to analyze and present your data.

5. Operational Plan

Outline the operational aspects of your clinical trial business, including staffing, facilities, equipment, and regulatory compliance. Detail your team's qualifications and roles, as well as any partnerships or collaborations with other organizations. Ensure that you have a clear understanding of the logistical requirements to successfully conduct clinical trials.

Utilize the Gantt chart feature in ClickUp to create a visual timeline that outlines the critical tasks and milestones involved in setting up and running your clinical trials.

6. Risk Assessment and Mitigation

Identify potential risks and challenges that may arise during the course of your clinical trials and develop strategies to mitigate them. This may include contingency plans for unexpected events, compliance with ethical guidelines, or addressing potential delays or budget constraints. Demonstrating that you have considered and planned for potential risks will inspire confidence in your business plan.

Create tasks and set up Automations in ClickUp to track and manage your risk assessment and mitigation strategies, ensuring that you stay on top of potential challenges.

By following these steps and utilizing ClickUp's Business Plan Template, you can create a comprehensive and well-structured business plan for your clinical trial endeavors. With a clear roadmap in place, you'll be better equipped to secure funding, attract collaborators, and achieve success in the competitive field of clinical research.

Get Started with ClickUp’s Business Plan Template for Clinical Trial Scientists

Clinical trial scientists can use the Business Plan Template for Clinical Trials to effectively plan and manage their research projects.

First, hit “Add Template” to sign up for ClickUp and add the template to your Workspace. Make sure you designate which Space or location in your Workspace you’d like this template applied.

Next, invite relevant members or guests to your Workspace to start collaborating.

Now you can take advantage of the full potential of this template to create a comprehensive business plan for your clinical trial:

• Use the Topics View to outline the key sections and topics of your business plan
• The Status View will help you track the progress of each section and ensure nothing falls behind
• The Timeline View allows you to visualize the project timeline and set important milestones
• The Business Plan View provides a holistic overview of your entire plan, making it easy to spot any gaps or inconsistencies
• The Getting Started Guide View offers a step-by-step guide to help you navigate and complete your business plan

Organize sections and tasks into four different statuses: Complete, In Progress, Needs Revision, To Do, to keep track of progress

Utilize the custom fields Reference, Approved, Section to add additional context and information to your tasks

Monitor and analyze tasks to ensure maximum productivity and successful completion of your clinical trial business plan.

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Institute of Medicine (US). Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing An Agenda for 2020: Workshop Summary. Washington (DC): National Academies Press (US); 2012.

Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing An Agenda for 2020: Workshop Summary.

• Hardcopy Version at National Academies Press

4 Creating a New Business Model for Clinical Trials

Costs of clinical trials have been rising in the United States ( DeVol et al., 2011 ). The workshop’s third session, “Aligning Cultural and Financial Incentives,” explored opportunities for developing a new business model for clinical trials based on the seamless integration of technological advances and research activities to realize increased efficiencies and reduced costs. Individual speakers also proposed greater harmonization of regulatory responsibilities and administrative processes. If such changes take place on a large scale, clinical trials could become more affordable and attractive to organizations, clinicians, and the public.

TRANSFORMING THE ECONOMICS OF CLINICAL TRIALS 1

While the technology for gathering clinical data for research has evolved over time, the business model supporting this technology clearly has not evolved with each stage of technology transformation. —Judith Kramer, Duke University Medical Center; and Kevin Schulman, Duke University Medical Center

Advances in IT combined with business model transformation could combine to form a critical step in achieving transformation of the CTE through lower cost, faster, and better data quality of clinical trials according to a background paper prepared by Judith Kramer, Associate Professor of Medicine, Duke University Medical Center, and Executive Director, Clinical Trials Transformation Initiative (CTTI), Duke Translational Medicine Institute; and Kevin Schulman, Professor of Medicine, Duke University Medical Center, and Gregory and Jeremy Mario Professor of Business Administration, Fuqua School of Business. (See “Transforming the Economics of Clinical Trials” in Appendix F .) The entities involved in the conduct of clinical trials have not followed the cost-reduction trajectory of other technology-intensive industries and thus have not attained a business transformation sufficient to reap the economic benefits of technologic change. Instead, rapidly rising costs of U.S. clinical trials contribute to cost increases in developing innovative health products. For example, the estimated cost of developing one new drug has been suggested to range from $500 million to $2 billion ( Adams and Brantner, 2006 ). The resulting high cost of conducting clinical trials constricts the pipeline for new drug development, limits the accretion of knowledge about drugs that are produced, deters a focus on innovation and improvements in trial design and conduct, and impedes the investigation of important public health inquiries.

Increasing costs stem in part from obstacles that exist within regulatory pathways or stem from administrative inefficiencies, including increasingly complex clinical trial protocols, abundant requirements issued by various levels of government and different governments and not harmonized to ensure consistency, and excessively risk-averse interpretations of regulations by trial sponsors. An example of the last is 100 percent source documentation of all clinical trial data even though regulators—both FDA and the European Medicines Agency (EMA)—do not require it. Some new structures, such as CROs, have arisen to help trial sponsors operate in the complex research environment. CROs are focused on efficiently conducting clinical trials according to current standards and client expectations and do not have as their mandate a goal of advancing innovation in clinical trial design and performance. According to some observers, CROs may improve efficiency for trial sponsors, but their business practices may also contribute to the current cost structure of clinical research.

According to the authors, new information technologies conceivably could alter the conduct of clinical trials. For instance, electronic data capture (EDC)—using a computerized system to gather clinical data in a clinical trial—has the potential to reduce total costs, prevent errors, and conserve the time expended by physicians, nurses, and data coordinators by replacing multiple paper entries on patients’ clinical progress with onsite, electronic entry. EHRs could also reduce recruitment and site-screening costs and, furthermore, could enable direct-to-patient research, limiting the involvement of physician intermediaries. Pfizer recently initiated the nation’s first clinical trial, in support of an IND application, that recruits participants over the Internet ( Mansell, 2011 ). Smart phones are another technology that can improve communication within research programs and facilitate recruitment of participants in trials. However, research entities continue to rely on legacy systems, such as freestanding site-specific monitoring mechanisms and IRBs, rather than having these functions centralized among all or most sites involved in the same trial. So long as research organizations persist in overlaying the old business model atop the new technologies, many potential efficiencies will not be realized.

A broad approach to ensure the business model for clinical trials keeps pace with technology and information needs and capabilities could be based on a research agenda that examines how research is conducted today. This research would point the way forward in terms of identifying potential issues, and pathways, to reach business transformation of clinical trials. The research agenda would be reassessed every 2 to 5 years to ensure that business and regulatory mechanisms keep pace with technologic advances and other changes in the economic, scientific, and health care environment surrounding the CTE. Suggested pathways and opportunities for moving research business models forward would therefore reflect findings that emanate from a forward-looking research agenda that considers the seamless integration of technology into research. Also, harmonization of regulations among multiple agencies, including different levels of government in the United States and different countries (including the European Union), could reduce the cost of monitoring trials. Regulatory relief also could come in the form of the establishment of safe harbors for business process innovation—to allow sponsors to follow certain promising pathways before regulations have been developed and finalized. Furthermore, enhanced clinical research education of health professionals could equip practitioners to contribute to strategic efforts to develop new ways to streamline clinical trials into clinical practice. Organizations that play a role in clinical research could reorient themselves toward economic efficiency, shed “sunk costs” such as legacy systems that no longer are needed, avoid overly cumbersome mechanisms for applying regulatory controls, and embrace new information technologies. Possible strategies mentioned during the presentation of the Discussion Paper and discussion with the workshop audience for resolving economic inefficiencies in clinical trials are summarized in Box 4-1 .

Selected Potential Strategies for Avoiding Unnecessary Costs in Clinical Trials. The following actions suggested by Kramer and Schulman and individual workshop participants could facilitate the creation of new business models for clinical research that (more...)

Feasible new business models could emerge to replace the highly labor-intensive and regulation-laden clinical trials system that predominates today. The adoption of new business models could be facilitated by the engagement of all sectors in the conceptualization of business transformation. 2 The uptake of new clinical trial business models could increase return on investment and introduce greater predictability and efficiency as a consistent attribute of the CTE.

IDENTIFYING OPPORTUNITIES TO IMPROVE REGULATORY FRAMEWORKS FOR CLINICAL TRIALS 3

Regulations are sometimes an excuse and sometimes a huge, real issue. —Kevin Schulman, Duke University Medical Center

Regulatory Harmonization

Paul Eisenberg, Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc., discussed regulatory challenges from an industry perspective, focusing on the need for greater regulatory harmonization (see also Chapter 5 ). According to Eisenberg, FDA’s IND application process in the United States, while not particularly onerous in any single respect, is overall more cumbersome than corresponding European or other foreign processes. A selection of problematic processes associated with U.S. regulatory frameworks suggested by Eisenberg includes

• the use of form 1572 (which other nations actually discourage) for clinical investigators;
• thorough and time-consuming FDA review of the formulation and processes that led to the development of the clinical trial materials used in a study under the IND process. By contrast, in Europe, products developed in accordance with Good Manufacturing Practice (GMP) guidelines are deemed safe, and trial practices that meet Good Clinical Practice (GCP) principles are deemed acceptable. In some countries, a clinical trial can begin with a “clinical trial notification,” or a single IRB approval of the trial protocol;
• undeveloped regulatory framework for the co-development of devices and drugs under the IND process in the United States. In the past decade, an increasing number of pharmaceutical products in development have come from large molecules that, by nature, are more complex in their delivery mechanisms to patients. Thus, large-molecule products in development might require syringes or other devices to be developed simultaneously so that individuals can benefit from these novel therapeutics;
• the evolving and somewhat confusing mechanism for reporting adverse events experienced by clinical trial participants (including immediate reporting of “serious” and unexpected events experienced by participants);
• management of privacy protections under the HIPAA privacy regulations; and
• frequent, time-consuming inspections conducted by multiple regulatory authorities at research sites outside the United States.

The United States is not always a regulatory minefield. For example, ethical review—the IRB process—actually tends to be more efficient in the United States than in other countries. Nevertheless, as a consequence of existing regulation-related challenges, Eisenberg said, pharmaceutical research and manufacturing firms that would otherwise prefer to conduct clinical trials at U.S. academic health and science centers may find themselves drawn instead to foreign venues for research.

Given the fact that research is conducted in many countries, opportunities for substantial collaboration and regulatory harmonization exist. One is the potential for a standard international nomenclature—to describe drug reactions, for example. Another opportunity that could be explored is the establishment of a worldwide clinical trial database, similar to ClinicalTrials.gov, but with broader participation from around the world. Joint or coordinated inspections for GCP constitute a third potential opportunity for international harmonization.

• OPPORTUNITIES FOR ALIGNING CULTURAL AND FINANCIAL INCENTIVES IN CLINICAL TRIALS

In a panel discussion, the session chair, panel presenters, Discussion Paper co-authors, and audience members reacted to and built upon the ideas contained in the Discussion Paper. Participants included session chair, Arthur Rubenstein, Professor of Medicine, Division of Endocrinology, Raymond and Ruth Perelman School of Medicine, University of Pennsylvania; Richard Rudick, Professor of Medicine and Hazel Prior Hostetler Chair of Neurology, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; Christopher Beardmore, CEO, Translational Research Management; and Scott Steele, Director of Research Alliances, University of Rochester. This section provides an integrated summary of their remarks and should not be construed as reflecting consensus or endorsement by the workshop participants, the planning committee, the Forum, or the National Academies.

The health care system is adopting widespread transformative practices, such as moving toward employment of physicians by large health care delivery systems (as opposed to individual physicians in private practice), use of performance measures in determining reimbursement, distance health monitoring, and other major changes. But, according to several participants, transformation of the CTE and of the health care system are proceeding on different tracks, even within institutions, such as AHSSs.

Cultural and Other Barriers

Workshop participants mentioned several possible cultural, economic, and regulatory barriers impeding transformation of the CTE into new business models. It was suggested by one workshop participant that older researchers are often less comfortable with new information technologies than younger researchers, which might hinder their involvement in the latest clinical trials. Another barrier is that regulatory and legal concerns make some people fearful of attempting innovations that could create liability problems for their institution. Some workshop participants noted that the public is not highly informed about science and research, and that there may be a casual attitude that is shared by political leaders and even clinical practitioners. In the current health care system, academic medicine is largely separate from community practice, and community practitioners may not view their job function as involving research. Rudick noted that clinical research and clinical investigators cannot function, let alone thrive, when they operate separately from the health care system. He stressed the need to integrate clinical trials, and more broadly clinical research, into the U.S. health care system in order to realize a truly transformed CTE.

It was noted that although the pluralistic U.S. health care system has several advantages over a monolithic system, such as avoiding some wasteful expenditures for large systems before they are piloted on a small scale, the fragmentation makes it difficult to achieve change quickly and universally. Cultural change also could be spurred by new regulatory approaches. For example, it was noted that establishment of an opt-out mechanism, where people are presumed to approve use of their patient records for research purposes unless they specify otherwise, could facilitate the secondary use of patient data for research purposes and promote the expectation of public participation in research.

Reimbursement and Economic Incentives

It is of signal importance for third-party payers to cover the costs of participation in clinical trials. Patients in trials can incur costs greater than patients in routine health care. Also, rational budgeting of clinical trials by sponsors is impossible without knowing which expenses are research administrative costs, to be paid by sponsors, and which are routine care costs, which may be required to be paid by insurers or patients. Some states already require payers to cover the routine medical care costs of patient participation in clinical trials. Section 10103(c) of the Patient Protection and Affordable Care Act requires coverage of routine patient care costs associated with clinical trials, with no discrimination against clinical trial participants, by the beginning of 2014.

An additional dimension of the reimbursement landscape is the fragmented nature of the U.S. health care system, including the existence of many payers. This fragmentation makes it difficult both to clarify which payer is responsible for covering the costs of a clinical trial and to have consistent and universal transformation of the business models for clinical trials. However, one participant noted that, because each payer makes its own coverage and payment decisions, an opportunity exists for providers to develop an innovative payment approach through negotiation with an individual payer (akin to a payer-specific demonstration program). Beardmore noted the feeling of some community oncologists that they are marginalized in discussions of cancer care policy and reimbursement reform despite the expectation that they will enthusiastically support and implement the programs and policies being developed ( Kolodziej, 2011 ).

He also noted that with respect to reimbursement, many large payers are moving toward value-based insurance design, in which payers link reimbursement levels to evidence on health outcomes to reduce waste ( IOM, 2007 ; Kapowich, 2010 ). One workshop participant suggested that this move indicates that cultural change about the value of research and evidence could ideally be partnered with a change in payment systems to demand (or “pull,” as opposed to “push”) more knowledge about treatments.

In addition to adequate compensation for patients and healthy volunteers participating in research, Eisenberg noted that insufficient compensation for clinical investigators is a problem that contributes to low levels of participation in and leadership of trials in the United States. Rudick also noted that there currently is no effective financing mechanism in place for clinical investigators in academic medicine, resulting in an unstable and unattractive career path.

Informatics

EDC, directed by a neutral entity operating via a system of cloud computing, can connect individual systems used by health care systems and research organizations. This interoperable approach could obviate the need for one unified data system. Alternatively, a central data repository could be established, with universally retrievable information about the capacity of research sites, the credentials of investigators, protection of human subjects, training, and other topics, thereby eliminating the need for the laborious and wasteful gathering of information to support each new trial.

Many informatics products now are legacy-driven. An AHSS that has invested in separate systems for billing and research does not have incentives to replace both systems with a new, integrated product. Different academic institutions have their own systems, and little interoperability exists. While federal regulators, health care providers, and the IT industry focus primarily on the “meaningful use” 4 of EHRs, according to a workshop participant they are not sufficiently investing in connectivity and the use of EHRs in the health care setting for clinical trials. Consequently, the records of patients who receive care from different providers, health systems, or academic institutions are all incomplete. It was suggested by one workshop participant to start increasing efficiency and interoperability by merging information for compliance systems such as financial disclosure forms. Billing, scheduling, and other processes also could be combined.

International Competition

Many participants noted that the United States will have to invest more heavily to remain competitive in the field of clinical research and to achieve more effective and value-driven health care. While other countries are increasing their commitment to medical research, in recent decades U.S. health policy concerns have been concentrated on cost containment. Clinical research has not been central to the discussion, even though research could lead to a significant reduction in expenditures for medically unnecessary procedures, which contribute to an estimated $750 billion to $765 billion of excess in annual U.S. health expenditures ( IOM, 2010b ).

Workshop participants expressed differing views about the best way to meet the challenge of globalization in clinical trials. One view was that it may make sense to let other countries undertake industry-driven studies, of the type regulated by FDA, while the United States moves into quality improvement and clinical effectiveness research as an area of growth. A contrasting view was that, to the extent clinical trials are moving offshore due to excessive U.S. research costs, this is a loss to the United States. In this view, research should be conducted in the United States if the results are to be applied to U.S. populations specifically. Another type of viewpoint offered at the workshop identified spillover benefits to conducting clinical trials in the United States. Trials are educational opportunities because knowledge of, or participation in, clinical trials facilitates dialogue among clinicians about developing medical evidence for new treatments or comparing products or interventions already in use. Clinical trials are also a source of jobs. And finally, clinical trials can result in improved clinical care for trial participants.

Building Consortia to Create Conditions for Change

When the U.S. semiconductor industry faced strong pressure from Japanese competition and other forces, a Semiconductor Manufacturing Technology consortium (SEMATECH) was formed to create elements of a single manufacturing infrastructure, supported with the pooling of funds and public–private partnerships. The consortium concept may be applicable to the challenges facing the CTE, according to Steele. The creation of consortia could enhance the current clinical trials infrastructure. Already the Biomarkers Consortium, managed by the Foundation for the NIH (FNIH), is developing common adaptive trial designs. The CTSAs and academic medical centers share training programs, improve common understanding about regulatory requirements, improve informatics, develop model clinical trial agreements, and achieve other infrastructure enhancements across the CTSA institutions. The consortia model also could help overcome cultural barriers to CTE transformation, by resolving problems in leadership and governance. For example, Steele suggested that a consortium could be developed to revamp the weighty IRB structure as currently used in clinical research. Interagency coordination also can be improved through coordinating councils with multiagency input.

This section is based on the presentations and Discussion Paper by Judith Kramer, Associate Professor of Medicine, Duke University Medical Center, and Executive Director, Clinical Trials Transformation Initiative (CTTI), Duke Translational Medicine Institute; and Kevin Schulman, Professor of Medicine, Duke University Medical Center, and Gregory Mario and Jeremy Mario Professor of Business Administration, Fuqua School of Business. (See Appendix F for the Discussion Paper “Transforming the Economics of Clinical Trials.”)

For example, currently, the CTTI, a collaboration between Duke University and FDA, is undertaking to combine the perspectives of more than 50 stakeholder organizations to develop new approaches and begin to point the way toward a new model for clinical trials.

This section is based on remarks made by Paul Eisenberg, Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc., and the Discussion Paper “Developing a Clinical Trials Infrastructure” (see Appendix G ).

The HITECH Act, part of the American Recovery and Reinvestment Act of 2009, allowed CMS to provide financial incentives to health providers for the adoption and “meaningful use” of certified EHR technology. Meaningful use entails three components: (1) the use of certified EHR technology in a meaningful manner, such as e-prescribing; (2) the use of certified EHR technology for electronic exchange of health information to improve quality of health care; and (3) the use of certified EHR technology to submit clinical quality and other measures. For more information, visit https://www ​.cms.gov/EHRIncentivePrograms/30_Meaningful_Use ​.asp (accessed March 28, 2012).

• Cite this Page Institute of Medicine (US). Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing An Agenda for 2020: Workshop Summary. Washington (DC): National Academies Press (US); 2012. 4, Creating a New Business Model for Clinical Trials.
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Clinical Trials Business Plan Template

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