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How to Start a Clinical Research Organization

Do you want to start a clinical research organization? If YES, here is a 20-step guide on how to start a clinical research organization with no money.

Please note that if you intend to start this type of business, it is advisable to first look at the existing laws and zonal regulations in the country or state you reside in to know what is expected of you. The bottom line is that you need to pay a visit to the regulatory bodies in your country to get all the information you need before you can legally open your clinical research organization in your city.

You can start your clinical research business from a small town in the United States. If you are good at what you do when it comes to coming up with breakthrough clinical research works and workable solutions to challenges for players in the healthcare cum medical industry, it won’t be too long before your brand becomes a nationally recognized brand.

Steps on How to Start a Clinical Research Organization Business

  1. Understand the Industry

The Contract Research industry that clinical research business is a subset of, is perhaps one of the fastest growing and largest industries in the world because the wealth of any nation depends on the health of the nation. 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 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 clinical trial support for drugs or medical devices.

A recent report published by IBISWorld shows that the Contract Research 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 a 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 in the increasing need of disease treatment.

The industry will also benefit from rising demand from biopharmaceutical companies. IBISWorld forecasts that industry revenue will increase over the five years to 2022. 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 share 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 industry are high due to the significant regulatory requirements and the experience and strength of incumbents.

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 levels and the business is indeed a profitable venture despite the legislation governing the industry.

  1. Conduct Market Research and Feasibility Studies

  • Demographics and Psychographics

The demographic and psychographic composition of those who require the services of clinical research organizations cut across all players in the health and medical care industry such as dental clinics, pharmaceutical companies, biotechnology companies, biomedical companies, Ministry of Health, medical devices development companies, and all medical clinics and hospitals.

In essence, the demographic composition for clinical research organizations is all encompassing. So, if you are thinking of starting your own clinical research business, then you should look beyond marketing your research services in your city, but also across the United States of America and even in other parts of the world.

  1. Decide on a Niche

There is no niche area of specialization in the clinical research business since clinical research business is a niche area in the Contract Research Organizations industry. Although some clinical research organizations may decide to specialize in any or all of the following;

  • 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
The Level of Competition in the Industry

The competition that exists in the clinical research organization goes beyond competitions in your city; it is both national and international. This is because, major clinical research organizations can be contracted from any part of the United States or abroad especially in Israel. So, it will be right to say the competition in the clinical research business is highly competitive.

The truth is that no matter the level of competition in an industry, if you have done your due diligence and you brand and promote your services or business properly, you will always make headway in the industry. Just ensure you come up with breakthrough clinical research works and workable solutions for players in the healthcare cum medical research industry and you know how to reach out to your target market.

But over and above, there are several clinical research organizations scattered all around the United States. So, if you choose to start your own business in the United States, you will definitely meet stiffer competitions amongst clinical research organizations in the United States.

  1. Know Your Major Competitors in the Industry

Here are some of the most popular clinical research organizations in the United States of America and the world at large;

  • IQVIA.
  • Advanced BioScience Laboratories
  • AlphaGenesis Incorporated (AGI)
  • Covance (LabCorp)
  • Syneos Health
  • PRA Health Sciences
  • Bio Analytical Research Corporation (BARC)
  • Parexel
  • Blue Sky BioServices
  • Charles River Laboratories
  • Clinical Device Group (CDG)
  • Clinical Research Consulting, Inc.
  • Davinci Biomedical Research Products, Inc.
  • Edinger Medical Group and Research Center
  • eResearchTechnology, Inc (ERT)
  • Fast-Track Drugs and Biologics
  • Fountain Medical Development (FMD)
  • Global Drug Development Experts (GDDE)
  • STATKING Clinical Services
  • Symphony Pharma Life Sciences.
Economic Analysis

If you are looking towards successfully launching a business and maximizing profits, then you need to ensure that you get your economic analysis right and try as much as possible to adopt best practices in the industry you choose to build a business in.

Clinical research business is no longer a green business, as a matter of fact, you will come across several brand names when you source for clinical research organizations in your state. So, if you are mapping out your economic analysis, you should carry out thorough market survey and costing of the required research materials, branding and other costs needed to successfully run the business.

Over and above, if you are considering starting a clinical research business, then your concern should not be limited to the cost of setting up the business and churning out a quality clinical research works, but also on branding and on how to build a robust business network.

The truth is that if you are able to build a robust business network, you are sure going to maximize profits in the business.

  1. Decide Whether to Buy a Franchise or Start from Scratch

Unfortunately, you can hardly find a franchise of a clinical research organization to purchase meaning that if you want to own a clinical research business, you must be ready to start from the scratch. The truth is that it will pay you to start your business from the scratch.

Starting from the scratch will afford you the opportunity to conduct thorough market surveys and feasibility studies before choosing a location to launch the business.

Please note that most of the big and successful clinical research organizations around started from the scratch and they were able to build a solid business brand. It takes dedication, hard work, and determination to achieve business success.

  1. Know the Possible Threats and Challenges You Will Face

If you decide to start your own clinical research organization today, one of the major challenges you are likely going to face is the presence of well–established clinical research organizations whose research works and solutions are used by major players all across the United States.

The only way to avoid this challenge is to create your own market perhaps by working with smaller health and medical organizations.

Other threats that you 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.

  1. Choose the Most Suitable Legal Entity (LLC, C Corp, S Corp)

When considering starting a clinical research organization, the legal entity you choose will go a long way to determine how big the business can grow. Generally, you have the options of choosing a general partnership, limited liability company, or a sole proprietorship for your business.

Ordinarily, sole proprietorship should have been the ideal business structure for a small-scale clinical research company especially if you are just starting out with a moderate start-up capital.

But if your intention is to grow the business and conduct clinical research for clients all across the United States of America, then choosing a sole proprietor is not an option for you. Limited Liability Company, LLC, or even general partnership will cut it for you.

Setting up an LLC protects you from personal liability. If anything goes wrong in the business, it is only the money that you invested into the limited liability company that will be at risk. It is not so for sole proprietorships and general partnerships.

Limited liability companies are simpler and more flexible to operate and you don’t need a board of directors, shareholder meetings and other managerial formalities.

These are some of the factors you should consider before choosing a legal entity for your clinical research organization; limitation of personal liability, ease of transferability, admission of new owners and investors’ expectation, and of course taxes.

If you take your time to study the various legal entities to use for your clinical research organization, you will agree that limited liability company; an LLC is most suitable. You can start this type of business as a limited liability company (LLC) and in the future convert it to a ‘C’ corporation or an ‘S’ corporation especially when you have plans of going public.

Upgrading to a ‘C’ corporation or ‘S’ corporation will give you the opportunity to grow your clinical research organization so as to compete with major players in the industry; you will be able to generate capital from venture capital firms, you will enjoy separate tax structure, and you can easily transfer ownership of the company.

  1. Choose a Catchy Business Name from the ideas Below

Normally, when it comes to choosing a name for your business, you should be creative because whatever name you choose for your business will go a long way to create a perception of what the business represents.

Typically, it is the norm for people to follow the trend in the industry they intend to operate from when naming their business. If you are considering starting your own clinical research business, here are some catchy names that you can choose from;

  • Research Pro® Clinical Research Organization, Inc.
  • Beth Martinez® Clinical Research Organization, LLC
  • Lazarus Morphy and Co® Clinical Research Organization, Inc.
  • International Clinical Research Corporation, Inc.
  • Michelle Monk® Clinical Research Organization USA LLC.
  • Shannon Stev® Clinical Research Organization, Inc.
  • Larry Chris® Clinical Research Organization, Inc.
  • Clinical Research and More® Inc.
  • Lance Institute® Clinical Research Organization USA LLC
  • South Gate® Clinical Research Organization, Inc.
  1. Discuss With an Agent to Know the Best Insurance Policies for You

In the United States and in most countries of the world, you can’t operate a business without having some of the basic insurance policies that are required by the industry you want to operate from. Thus, it is imperative to create a budget for insurance and perhaps consult an insurance broker to guide you in choosing the best and most appropriate insurance policies for your business.

Here are some of the basic insurance policies that you should consider purchasing if you want to start your own clinical research organization in the United States of America;

You can contact the following leading insurance companies in the United States of America to purchase the needed insurance policies for your clinical research business;

  • Allstate Insurance Group
  • Liberty Mutual
  • Progressive Insurance Group (PGR)
  • Health Care Service Corporation (HCSC)
  • New York Life Insurance Company
  • Lincoln National Life Insurance Company
  • MassMutual (Massachusetts Mutual Life Insurance Company)
  • Northwestern Mutual Life Insurance Company
  1. Protect your Intellectual Property With Trademark, Copyrights, Patents

If you are considering starting your own clinical research organization, you need to file for intellectual property protection/trademark. This is because the nature of the business makes it impossible for you to successfully run the business without having any cause to challenge anybody in court for illegally making use of your company’s intellectual properties.

So, in essence, if you want to leverage on these business opportunities within the industry and also to protect your unique design, company’s logo, and other documents or software that are unique to you or even operation concepts, then you can go ahead to file for intellectual property protection. If you want to register your trademark, you are expected to begin the process by filing an application with the USPTO.

  1. Get the Necessary Professional Certification

Aside from your ability to come up with clinical researches, professional certification is one of the main reasons why you will be able to stand as a clinical researcher. You are strongly encouraged to pursue professional certifications; it will go a long way to show your commitment to the business.

Certification validates your competency and shows that you are highly skilled, committed to your career, and up-to-date in the market. These are some of the certifications you can work towards achieving if you want to run your own clinical research organization;

  • ACRP Certified Professional.
  • ACRP Medical Device Professional Subspecialty
  • ACRP Project Manager Subspecialty

Please note in order to become a certified clinical research associate, you should complete 3,000 hours performing essential job duties or 1,500 hours of equivalent work experience requirements through ACRP certifications or approved clinical research degree programs accredited by the Council for Higher Education. Submit a resume documenting and demonstrating job performance.

  1. Get the Necessary Legal Documents You Need to Operate

It is a fact that you cannot successfully run any business in the United States without the proper documentation. If you do, it won’t be too long before the long hands of the law catch up with you. These are some of the basic legal documents that you are expected to have in place if you want to legally run your own business in the United States of America;

  1. Raise the Needed Startup Capital

Starting a standard clinical research organization is capital intensive even if you choose to launch the business on a small scale and you only have a handful of full–time employees on your payroll.

Leasing of a standard laboratory facility that can accommodate your research equipment and staff members and equipping the facility are part of what will consume a large chunk of your startup capital, in essence, if you choose to start the business on a small scale, you will still have to source for fund to finance the business.

No doubt when it comes to financing a business, one of the first things you should consider is to write a good business plan.

If you have a good and workable business plan document in place, you may not have to labor yourself before convincing your bank, investors and your friends to invest in your business. Here are some of the options you can explore when sourcing for start-up capital for your clinical research business;

  • Raise money from personal savings and sale of personal stocks and properties
  • Raise money from investors and business partners
  • Sell shares to interested investors
  • Apply for a loan from your bank or banks
  • Pitch your business idea and apply for business grants and seed funding from government, donor organizations, and angel investors
  • Source for soft loans from your family members and your friends.
  1. Choose a Suitable Location for your Business

When it comes to choosing a location for your clinical research business, the rule of thumb is that you should be guided by the demand for such services and easy access to labor and research materials. Of course, if you are able to secure a central location for your clinical research organization, it will enable you cut the cost of transporting access to medical facilities.

It cannot be overemphasized that the location you choose to open your clinical research business is key to the success of the business, hence entrepreneurs are willing to rent or lease a facility in a visible location; a location where the demography consist of robust players in the health and medical industry.

If you make the mistake of renting or leasing a facility for your clinical research organization in a not too visible or hidden location simply because it is cheap, then you must be prepared to spend more in promoting the business and perhaps giving direction to potential clients.

It is important to note that a business facility in good location does not come cheap hence you should be able to allocate enough fund for leasing / renting in your budget. If you are new to the dynamics of choosing a location for your business, then you should feel free to talk to a business consultant or a realtor.

Most importantly, before choosing a location for your clinical research organization, ensure that you first conduct a thorough feasibility study and market survey. The possibility of you coming across a similar business that just closed shop in the location you want to open yours can’t be ruled out.

Having said that, these are some of the cities in the United States of America where you can locate your clinical research organization;

  • Brattleboro, Vermont
  • Tucson, Arizona
  • Silver Spring, Maryland
  • Rowland Heights, California
  • Portland, Oregon
  • Richmond, Virginia
  • Green Bay, Wisconsin
  • Plano, Texas
  1. Hire Employees for your Technical and Manpower Needs

If you are considering setting up a clinical research organization, it means that you should be prepared to set up a standard research center. If you don’t have enough cash, you can start from a small laboratory.

As regard leasing or outright purchase of a research facility or laboratory facility, the choice is dependent on your financial standings, but the truth is that to be on the safe side, it is advisable to start off with a short–term rent/lease while test running the business in the location. If things work out as planned, then you go on a long-term lease or outright purchase of the property but if not, then move on and source for another ideal location.

When it comes to hiring employees for a standard clinical research business, you should make plans to hire a competent Chief Researcher / Chief Executive Officer (you can occupy this role), Clinical Research Fellows, Clinical Research Associates, Office Administrator, Accountant, Marketing Executives and Client Service Executive. On the average, you will need a minimum of 5 to 15 key staff members to run a small-scale but standard clinical research organization.

The Service Delivery Process of the Business

This is how clinical research organizations work; as an independent organization that steps into the development process, once a pharma company has identified a promising new molecule, a clinical research organization will organize and conduct clinical trials to test the new molecule in humans.

Clinical research organizations engage in performing clinical research for pharmaceutical, biomedical and biotechnology companies, and performing clinical research for medical device manufacturers. Clinical research organizations will also carry out data management and regulation adherence services and of course, development, advancement, and formulation of devices and medications.

  1. Write a Marketing Plan Packed With ideas & Strategies

Running a business requires that you should be proactive when it comes to marketing your goods or services. If you choose to launch a clinical research organization, then you must employ strategies that will help you attract customers, or else you will likely struggle with the business because there are well–known brands that determine the market direction for clinical research industry.

Your marketing strategy will center on breakthrough research works, quality and pricing, and above all excellent customer service. The truth is that if you are able to put the above stated in place, you won’t struggle to retain your old customers and at the same time win over new customers.

So, when you are drafting your marketing plans, make sure that you create a compelling company profile. Aside from your qualifications and experience, it is important to clearly state what you have been able to achieve in time past. This will help boost your chances when marketing your clinical research services. Here are some of the platforms you can utilize to market your clinical research organization;

  • Introduce your clinical research organizations by sending introductory letters alongside your brochure to 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 and Canada.
  • Advertise on the internet on blogs and forums, and also on social media like Twitter, Facebook, LinkedIn to get your message across
  • Create a basic website for your business so as to give your business an online presence
  • Directly market your clinical research organization
  • Join local clinical research associations for industry trends and tips
  • Advertise our business in international and national newspapers, local TV and radio stations
  • List your business on yellow pages ads (local directories)
  • Encourage the use of word of mouth marketing (referrals)
  1. Work Out a Reasonable Pricing for your Services 

One key factor that will help you offer your clinical research work at rock bottom prices is to purchase your research materials and supplies directly from sources as against going through third parties. The truth is that if you source your research materials directly from sources you will get them at a premium price.

You can also try as much as possible to work with independent contractors and marketers, it will help you save cost of paying sales and marketing executives. So also, if you are able to secure a business partnership as it relates to getting referrals, then you will be able to get the right pricing and of course maximize profits from your business.

  1. Develop Iron-clad Competitive Strategies to Help You Win

The clinical research business is not so much a competitive industry because of the few players in the industry, but you must come up with a unique and highly creative strategy to be able to outsmart your competitors in the industry. Part of what you need to do in order to stay competitive in the industry is to ensure that your clinical research works are well designed to fit with the trends and safety must also be your guiding principle.

In other to stay competitive in this industry, you must ensure that your clients are always comfortable when making use of your clinical research works and always ensure that you pay attention to details when carrying out your job. The truth is that if there are fluctuations in the quality of your research works, customers can choose to shift allegiance and settle for other options available.

  1. Brainstorm Possible Ways to Retain Clients & Customers

When it comes to business, no matter the industry that you choose to pitch your tent in, one of the easiest ways to increase customer retention and perhaps attract new customers is to produce results and satisfy your customers always. If your customers are satisfied with your products and service delivery, they can hardly source for alternative service providers.

If your services and customer service fluctuate, you are likely going to struggle to get your customers coming back. Ensure that you offer your customers incentives if you want to retain them and of course continue to generate repeated sales from them and also attract new customers.

Part of what you need to do to achieve this is to track progress, results, or outputs with the aim of improving on them quickly as the case demands. When it comes to managing your customers and building a loyal clientele base, you should purchase customized CRM software.

With a customized CRM system, you can easily stay in touch with your clients (you can carry out quick surveys, you can introduce new products and prices to them without any hitch, you can felicitate with them on their birthdays and other anniversaries, you can keep track of their progress, you can send bulk SMS and customized emails and above all, you can easily receive compliant and feedback from them).

  1. Develop Strategies to Boost Brand Awareness and Create a Corporate Identity

If you are in business and you are not conscious about boosting your brand awareness and communicating your corporate identity, then you should be ready to take on whatever the society portrays your business to be. One of the secrets of larger corporations is that they are willing to spend fortunes to boost their brand awareness and to continue to communicate their corporate identity the way they want people to perceive them to be.

No matter the industry you belong to, the truth is that the market is dynamic and it requires consistent brand awareness and brand boosting cum promotion to continue to appeal to your target market. Here are the platforms you can leverage on to boost your brand and create a corporate identity for your clinical research organizations – business;

  • Place adverts on both print (newspapers and health magazines) and electronic media platforms
  • Sponsor relevant international and community-based events
  • Leverage on the internet and social media platforms like; Instagram, Facebook, Twitter, YouTube, Google + et al to promote your clinical research organization
  • Install your billboards in strategic locations all around your city or state
  • List your clinical research organization – business in local directories / yellow pages
  • Advertise your clinical research organization – business in your official website and employ strategies that will help you pull traffic to the site
  • Position your Flexi Banners at strategic positions in the location where your clinical research organization – business is located.
  • Ensure that all your staff members wear your branded shirts and all your vehicles are branded with your company logo.