Coté Orphan, a regulatory affairs advisory firm based in Silver Spring, Md., has added a new line of service for its clients by providing CRO services that will help organizations navigate the clinical trials process through the lens of regulatory affairs. With the addition of the CRO services, Coté Orphan provides companies a complete and robust solution to those developing or seeking to develop orphan drugs.

According to research from the Center for Information & Study on Clinical Research Participation (CISCRP), the process of creating a safe, useful medicine can take more than 20 years from start to finish. Further, CISCRP’s research finds that only 19% of drugs in the clinical trial process are even submitted to the FDA for approval.

Coté Orphan now will provide clients with a valuable service that designs clinical trials for orphan drugs to fit the current regulatory frameworks set forth by the FDA and the EMA. Dr. Timothy Coté, CEO of Coté Orphan, recently was the director of the FDA’s Office of Orphan Product Development and is utilizing his experience and knowledge in the regulatory process while at the FDA to provide an invaluable service to organizations undertaking clinical trials.

Coté said, “We see this as a natural evolution in services that are vital for the orphan drug development process. By designing trials processes that are already in compliance with current regulations, we are helping to drastically cut the time to market for these types of drugs. This, in tandem with our other planning and execution services, puts us in a position to provide a one-stop-shop service to clients—from inception through to acceptance.”

Coté Orphan has tapped Harry Cook, possessing more than 36 years of experience in the pharmaceutical industry, as director of the clinical operations. Cook’s experience includes major exposure to the NDA process and hands-on oversight of the clinical function, including clinical trial design, budgeting, investigator selection, site initiation, monitoring, data analysis, report writing and pharmacovigilance. Cook has either led or been instrumental in more than 14 major drug submissions in the U.S. and abroad in a variety of therapeutic areas.