Clinical Research:
Who Are The Players on a Clinical Research Team for?An Emerging Biotech Company?
Originally Published in CanBiotech BioMed Outsourcing Newsletter: Volume 1, Issue 1, September 2002

By STATKING Consulting Inc.
Dennis W. King, President

After securing financing and developing a prototype product, the next hurdle to be crossed for an emerging biotech pharmaceutical or medical device company is executing the company’s clinical research plan. The clinical research plan gives the strategy for gaining regulatory approval from the countries in which the company wishes to sell the drug or device. The key elements of the clinical research plan are the controlled clinical trials (CCTs) that will indicate whether the drug/device is safe and efficacious to the regulatory body. These controlled clinical trials are conducted under Federal regulations and guidelines generally known in the United States as Good Clinical Practice (GCP) guidelines.

Because of the broad set of experience needed to execute a CCT, a clinical research team will be formed by the emerging biotech company to execute the clinical trials necessary for regulatory approval. The clinical research team usually consists of a project manager, a regulatory consultant, a medical advisor, a statistician, a data manager, the study coordinator for each study site, the investigator for each study site, a medical writer and a representative from the biotech company. The company representative makes financial decisions concerning the clinical trials and represents the biotech company’s strategic interests.

The project manager is the central figure in the clinical research team. This person organizes team meetings, develops timelines and budgets for the trials and promotes the interaction of team members in moving the clinical trials forward. This individual may be a contractor or an employee of the biotech company. The regulatory consultant should be knowledgeable of both the manufacturing and GCP regulations for the countries in which the company is seeking approvals. The medical advisor works with the site investigators concerning the medical aspects of the trials. The medical advisor and the investigators are usually physicians with experience in the therapeutic area where the drug/device will be used. The statistician helps with the design of the study, the development of the protocol and case report forms and the analysis of the data from the study. The statistician is a key contact with the regulatory agency should the agency have questions about the results of the trials. The data manager controls the clinical study database for each clinical study. The data manager overseas a staff of data management professionals, including clinical study monitors, who work to guarantee quality data in the database. The site coordinator at each study site works with the clinical study monitor to insure that the case report forms, the records of data for the study, are correctly completed. The medical writer coordinates with several members of the clinical research team to write all the documents (protocol, study reports and submission documents) necessary for regulatory approval of the product.

Emerging biotech companies will outsource all or part of the clinical research team to individual consultants or contract research organizations (CROs). Our company, STATKING Consulting, Inc. is a data-related services CRO. Our company can provide biostaticians, data managers, clinical study monitors, project managers and medical writers for clinical research teams.

In forming the clinical research team, the emerging biotech company should consider (a) how much of the clinical research team will be outsourced, (b) the experience level of consultants and contractors to be hired and (c) who will represent the biotech company on the clinical research team. A clinical research team that can interact efficiently will increase the chances of a speedy regulatory approval of the company’s product.