Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, has launched its Clinical Trials Planning and Oversight Group. The group will help small and medium-sized biopharmaceutical companies in the development and management of efficient and cost effective clinical trials. Biologics Consulting has a broad range of global clinical trial experience and clinical operations expertise that it will leverage to help clients design trials to meet the ethical, regulatory and scientific standards required to obtain successful product development outcomes.
The Clinical Trials Planning and Oversight Group works closely with clients, investigators and CROs to design the most appropriate and efficient clinical programs to obtain the data necessary for FDA approval. Services range from designing and implementing a full clinical trial program, to serving as an in-house expert on various aspects of the program including: writing and reviewing clinical protocols, designing reports, monitoring data, overseeing and managing CRO/vendor selection, operations and budget negotiations, trial monitoring, and review and presentation of clinical data, among others.
"Orchestrating a successful clinical trial is one of the greatest challenges that small and medium-sized biopharmaceutical companies face. Our Clinical Trial Planning and Oversight consulting services are designed to make it easier for biopharmaceutical companies to navigate the process and realize successful outcomes," said Norman Baylor, Ph.D., president and CEO of Biologics Consulting. "There is a significant need for this type of service and we have the in-house experience and expertise necessary to fill the void that currently exists in the market."