Guide to Pharmaceutical Clinical Trials

Almost half of all Americans take a prescription medication, according the U.S. Department of Health and Human Services. With prescription drug use on the rise, the demand for pharmaceutical clinical research continues to increase.

To keep up with the growing research needs, members of the pharmaceutical industry often outsource pharmaceutical clinical trial services to clinical research companies.

If your company chooses to obtain the services of a pharmaceutical clinical trial company, evaluate the following:

1. What services does the clinical research company provide?
2. How experienced is the company in pharmaceutical clinical trials?
3. How does the pharmaceutical clinical research company measure quality performance?

Action Steps
The best contacts and resources to help you get it done

Evaluate the ability of the pharmaceutical clinical trial services company to meet your needs

Clinical research companies offer a wide range of services including pharmaceutical clinical trial management, laboratory processing, data management and marketing. Make sure your research firm specializes in services to meet your company's particular needs.

I recommend: Coastal Carolina Research Center is a pharmaceutical clinical trial services facility primarily focused on conducting clinical trials on behalf of pharmaceutical companies. They offer two equipped pharmaceutical clinical research sites and a staff of investigators, coordinators, management and support personnel. SeqWright’s clinical trial services focus on custom molecular biology services. BioClin Health Research, Inc. specializes in pharmaceutical clinical trial management, clinical trial coordination and clinical trial financial services.

Examine the pharmaceutical research company's experience with medications and industry organizations

Experience is important when it comes to pharmaceutical clinical trials. Find out how much experience each clinical trial management company brings to the table, not just in years of experience but also in the number of pharmaceutical clinical trials. Ask for a listing of pharmaceutical companies the clinical monitoring company worked with, research studies completed and number of patients enrolled.

I recommend: Coastal Carolina Research Center’s 7 study coordinators possess a total of 80 years of research experience. The clinical trial services company provides a list of studies on their website. Jacksonville Center for Clinical Research offers a listing of their clinical trials sponsors, contract research organizations and therapeutic areas of expertise. Pinnacle Research Group also lists their pharmaceutical clinical research experience online. Pharmaceutical Research Organization cites working with 63 pharmaceutical companies, 36 contract research organizations and 45 independent and private-practice investigators to conduct 250 research studies with more than 7,600 patients.

Research pharmaceutical clinical trial companies to assess performance quality

Your company strives to develop safe and effective ways to treat and prevent disease. Make sure your pharmaceutical clinical trial management firm is committed to patient safety and ethical standards throughout the research process. Ask about their quality control standards.

I recommend: Coastal Carolina Research Center offers a comprehensive online standard operating procedures guide and a section of their website dedicated to previous audits. SeqWright developed a Quality Assurance Program to support its pharmaceutical clients and now hosts monthly audits. Pinnacle Research Group received positive audits without citations from institutional review boards, sponsors and the Food and Drug Administration.

Tips & Tactics
Helpful advice for making the most of this Guide

• When outsourcing pharmaceutical clinical trial services, many different departments will be involved based on the services rendered. Ask for one primary contact to provide consistent information in a timely manner.

The official source of Pharmaceutical Clinical Trials is
the Pharmaceutical Clinical Trials page at Business.com