Starting a Clinical Research Business: Unlike other businesses, clinical research business is one of the most complex businesses in the world. The business is highly regulated and supervised because they deal directly with human life. It is so complicated because you will need human volunteers to participate in your clinical research and trials.

If you are someone who loves research and someone who dares things, then clinical research business is an ideal business for you. Clinical research study people with the aim of advancing knowledge in the medical world, this is done by interacting directly with the people or by collecting and analyzing their tissues, blood sample and other samples.

Clinical research and clinical trial go together, while clinical research is broad, a clinical trial is a type of clinical research that monitors a protocol or predefined plan. This is the most popular type of clinical research upon which this guide is drafted. Clinical trials require volunteers (participants), who play an active role in contributing to medical research. They have access to experimental treatments and work to improve their own healthcare.

Clinical Research Business Global Market Outlook

As an entrepreneur reading this, I know you may be at a crossroad whether clinical research business is worth investing your money, whether it can return back your investment with profit. Let me inform you that the industry is worth over US$200 billion globally and clinical trials alone have taken up to US$50Billion.

In India, an annual growth rate of 45% has been recorded; this is opening up new business opportunities for entrepreneurs to invest in clinical trials as a result of this consistent growth in the industry. Entrepreneurs are investing seriously in:

• Clinical Data Management Centres
• Clinical Operations
• Pharmacovigilance KPO
• Regulatory affairs(Monitoring Services)
• Training & HR Services
• Biostatistics
• Clinical Trial Logistics services
• Patients Admission and retention service
• Quality Auditing & Assurance
• Clinical Research Lab Services

What you will be doing as a Clinical Researcher

• Defines the effectiveness and safety of medications (drugs and therapies)
• Determines the safety of diagnostic products and treatment procedures proposed for human consumption
• Determine how to diagnose, treat, cure or prevent disability and disease.

Types of Clinical Research you should know:

Clinical Research Study of Natural history– This is to provide valuable facts on the evolution of disease and health progress.

Prevention Clinical Research– this research is aimed at finding a means of preventing a particular disease from affecting those that have never had it previously and from returning to people that have suffered it. Such research findings may come up with a recommendation to change of lifestyle, new vaccines, medicines etc.

Screening Clinical Research –This clinical research is to test the most appropriate way to identify some diseases and certain health conditions.

Diagnostic Clinical Research –aimed at defining better procedures or test for diagnosing certain conditions and diseases.

Treatment Clinical Research –treatment research is to identify new drug combinations, new treatments, new radiation therapy and new methods of surgery.

Clinical Research in Quality of life –this is targeted at people with protracted diseases to measure and explore avenues to enhance their quality of life and comfort. This is also called Supportive Care Clinical Research or trials.

Stages of clinical trials you should know as a Clinical Research Entrepreneur

I cannot tell you how to establish a business that you don’t know what it entails, that is why I am taking time to take you through some important things you need to know about the business and its demands. Clinical research has to pass through all these four phases of the clinical trial as listed below before it can be used to evaluate devices and medications. Each of the trial stages has a unique purpose, which helps the researchers to answer various medical research questions:

• Phase I trials – This is the stage where the clinical researcher tests the treatment or the experimental drug on a small set of volunteers to determine the safety, evaluate the ideal prescription range and detect side effects.

• Phase II trials – At this phase, larger group volunteers are given the treatment or experimental drug to further determine its safety and effectiveness.

• Phase III trials – This is the combination of both phase I and II trials but with larger groups of volunteers. Here the scientists confirm its efficacy, compare the treatment with the universally used treatments and observe if there are any side effects. Information gathered are now collected by the researcher, which will now allow the treatment or experimental drug to be safe.

• Phase IV trials – This is the last phase of the clinical trial phases; this phase deals most with studies after marketing the treatment or the experimental drug. This phase is conducted after the approval of the treatment to provide additional information including the benefits, risks and the best way to use the drug and the treatment.

Establishing your own Clinical Business

Starting a clinical research business is capital intensive; most of the equipment and tools for clinical research are very expensive. Most clinical research endeavours are sponsored by the government, NGO, pharmaceutical companies and other reputable organisations. Follow this guide to know how to start your own clinical research business today.

Do Research about the Business

Clinical research business is a knowledge business, where you do series of experiments to find solutions to certain health problems. You should, therefore, conduct thorough research in the business to know the health or biotech problem that people, pharmaceutical companies, governments etc are desperately searching for solutions.

This is the foundation of clinical research business; this will give you the boldness to venture into it knowing that market is not your problem. Also, capital can be generated for your clinical research from organisations like governments, pharmaceutical companies, and biotech companies etc who are interested in such solutions.

Equipment and Location

Your research should determine your location. Though, a solution to a problem does not have respect for location, as you can always be traced if you have solutions to a problem; but it is, however, important that where you be easily assessed for people to interact with you. You should put the cost of rent, transportation, and other logistics into considerations before choosing a location.

You may not have capital now to acquire the necessary equipment, don’t worry; there are companies that do rental of clinical research equipment, which is another business in the clinical research business.

Possible Clients

A clinical researcher does business mostly with governments, Biotech Companies, Pharmaceutical companies, Non-Governmental Organisations (NGOs), Hospitals and Educational Research Institutions.

Initial Cost Outlay

The initial cost of starting clinical research business service is relatively in the middle of higher ranges. Startup costs for clinical research business is the same as for any individual starting a medium to large size business in Africa. ($150,000 – $500,000).