Do you want to start a contract research organization? If YES, here’s a 20-step guide to starting a clinical research organization with no money in 2022. Please note that if you intend to start this type of business, it is a good idea to first check the existing laws and zoning regulations in the country or state you live in so that you know what is expected of you.
The bottom line is that you need to visit the regulatory authorities in your country to get all the necessary information 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 in terms of coming up with breakthroughs in clinical research and workable solutions to challenges for players in the healthcare and medical industry, it won’t take long for your brand to become a nationally recognized brand.
Understand contract research organization industry
The contract research industry, a subset of which is clinical research, 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 healthcare and the medical industry are not treated with all seriousness.
In fact, the healthcare industry, along with the contract research industry, is known to swallow more than 10 percent of the 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 (CROs) provide biopharmaceutical development, preclinical research, clinical research, and clinical trial management. Many contract research organizations specifically provide support for clinical trials and clinical trials 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 demand for industry services has grown over the past five years as clients increasingly use their research and development (R&D) budgets to outsource contract research organizations.
Demography and psychology
As a result, industry sales are expected to grow at an annual rate of 7.1 percent to $17.1 billion over the five years to 2016, including projected growth of 6.3 percent in 2016 alone. years of aggressive growth, benefited from an aging US population and an expansion in private spending on health-related research and development (R&D).
As a result, the industry’s revenue is expected to grow in the five years to 2016. Over the next five years, the industry will continue to benefit from increased research and development spending and an aging US population in increasing need for disease treatments.
The industry will also benefit from increasing demand from biopharmaceutical companies. IBISWorld predicts that revenue from this industry will increase over the five years to 2022. Statistics say that in the United States, the industry is worth $17 billion with an estimated growth rate of 7.1 percent.
There are about 3,585 registered and licensed contract research organizations with clinical research businesses in the United States, and they are responsible for employing about 5,513,669 people. LabCorp and Quintiles are industry leaders and boast the lion’s share of the available market in the United States.
If you are thinking of starting your own clinical research company in the United States, you should try to work around the obstacles in this industry. The truth is that barriers to entry in the contract research industry are high due to significant regulatory requirements and the experience and strength of incumbents.
Some of the factors that encourage entrepreneurs to start their own clinical research business may be that the business can easily get support from government at all levels and that the business is indeed a profitable business despite the legislation that governs the industry.
Conduct market research and feasibility studies
The demographic and psychographic composition of those requesting the services of clinical research organizations is across all players in the health and medical care industry, such as dental clinics, pharmaceutical companies, biotechnology companies, biomedical companies, the Ministry of Health, medical device development companies and all medical clinics and hospitals.
The demographic makeup of clinical research organizations is essentially all inclusive. 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 in the United States and even other parts of the world.
Decide on a niche
There is no specialized field in the field of clinical research because clinical research is a specialized field in the contract research organization industry. Although some clinical research organizations may choose to specialize in some or all of the following;
- Conducting clinical research for pharmaceutical, biomedical and biotechnology companies
- Conducting clinical research for manufacturers of medical devices
- Data management and compliance services
- Development, advancement and formulation of devices and drugs
- The level of competition in the industry
The competition that exists in a clinical research organization goes beyond the competition in your city; it is both national and international. This is because large clinical research organizations can be contracted from any part of the United States or from abroad, especially in Israel. So it will be correct to say that the competition in the field of clinical research is highly competitive.
Also read:- What Do Gastroenterology Clinical Trials Do?
The truth is that regardless of the level of competition in an industry, if you have done your due diligence and properly brand and promote your services or business, you will always make progress in the industry. Just make sure you come up with breakthrough clinical research papers and functional solutions for players in the healthcare and medical research industry and know how to reach your target market.
In addition, however, there are several clinical research organizations scattered throughout the United States. So if you decide to start your own business in the United States, you will definitely face tougher competition among clinical research organizations in the United States.
Know your main competitors in contract research organization industry
Here are some of the most popular clinical research organizations in the United States 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 to start a business successfully and maximize your profits, you need to ensure that your economic analysis is sound and try as much as possible to adopt best practices in the industry in which you choose to build your business.
A clinical research business is no longer a green business, in fact you will come across several brands when sourcing for clinical research organizations in your state. So if you are mapping out your economic analysis, you should do a thorough market research and estimate the required research materials, branding and other costs needed to run the business successfully.
Furthermore, if you are considering starting a clinical research business, your concerns should not be limited to start-up costs and quality clinical research, but also to branding and how to build a robust business. Sew. The truth is that if you are able to build a robust business network, you are sure to maximize your business profits.
Decide whether to buy a franchise or start from scratch
Unfortunately, it is rare to find a clinical research organization franchise for purchase, which means that if you want to own a clinical research business, you must be prepared to start from scratch. The truth is that it pays to start a business from scratch.
Also read:- Ophthalmology CRO Services – What You Need To Know
Starting from scratch will give you the opportunity to conduct thorough market research and feasibility studies before choosing a location to start your business. Please note that most of the large and successful clinical research organizations around have started from scratch and have been able to build a solid brand. It takes dedication, hard work and determination to achieve business success.
Know the potential threats and challenges you will face
If you decide to start your own clinical research organization today, one of the main challenges you will likely face is the presence of well-established clinical research organizations whose research work and solutions are used by major players across the United States. The only way to avoid this challenge is to create your own market, perhaps in collaboration with smaller health and medical organizations.
Other threats you are likely to face are economic downturn and unfavorable government policies (slowing down the release of funds to the R&D organization). The growth of a few dominant operators has actually led to an increasing level of concentration.
Select the most suitable legal entity (LLC, C Corp, S Corp)
When considering starting a contract research organization, the legal entity you choose will have a lot to do with how big the business can grow. In general, you have the option of choosing to be a public company, a limited liability company, or a sole proprietorship for your business. Under normal circumstances, a sole proprietorship should be the ideal business structure for a small clinical research company, especially if you are just starting out with modest seed capital.
However, if your intention is to grow your business and conduct clinical research for clients across the United States, then the sole proprietorship option is not for you. A limited liability company, LLC, or even a public company will cut it for you.
Setting up an LLC protects you from personal liability. If something goes wrong with the business, only the money you have invested in the limited company will be at risk. It does not apply to individual companies and public companies. Limited liability companies are simpler and more flexible to operate and you do not need a board of directors, shareholder meetings and other management formalities.
Factors You Should Know About
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, acceptance of the expectations of new owners and investors, and of course taxes.
Also read:- What is a CRO (Contract Research Organization)?
If you take the time to research the various legal entities to use for your clinical research organization, you will agree that a limited liability company; LLC is best. You can start this type of business as a Limited Liability Company (LLC) and convert it to a “C” or “S” corporation in the future, especially if you plan to go public.
Upgrading to a “C” or “S” corporation will give you the opportunity to grow your clinical research organization to compete with the major players in the industry; you will be able to generate capital from venture capital firms, you will be able to enjoy a separate tax structure and you can easily transfer ownership of the company.
Choose a catchy business name from the ideas below
Normally, you should be creative when choosing a name for your business, because whatever name you choose for your business will go a long way to creating an idea of what the business stands for. It is usually the norm for people to follow the trend in the industry they intend to operate in when naming their business.
If you are considering starting your own clinical research business, Contact Vial for more information.
