Clinquest - Your Partner From Bench to Market

Medical Affairs & Strategic Development

Our Medical Affairs and Strategic Development Practice guides emerging biotechnology, pharmaceutical, medical device and medical diagnostics companies through the entire product development process, from research and development through market approval. Our Medical Affairs professionals provide our clients with strategies that help maximize the commercial value of their product development programs.

Our professionals have a proven track record of superior leadership and success in the management of clinical development programs. The Medical Affairs and Strategic Development Practice often serves as our clients' Medical Affairs Department, developing and facilitating research projects that support our clients' full medical-use and commercial objectives. This close working relationship ensures that our clients' research efforts are medically sound and meet current regulatory requirements.

The Medical Affairs Practice provides our clients with:

Medical and technical expertise, regarding the development program.
Managerial oversight and leadership, to the clinical group implementing clinical trials and the project team to ensure that corporate milestones are reached.
A liaison with potential clinical investigators and academia, to initiate clinical trials.
Medical expertise, for selecting clinical investigators and sites, protocol and investigator brochure development, study and safety report writing and the writing of medical sections of regulatory applications.
Medical monitoring, a safety review of data obtained during a clinical trial, the application of stopping rules and regulatory expertise regarding AEs/SAEs and reporting. Advisory board meetings with experts in the client's therapeutic field, which are conducted and chaired by the Medical Affairs Practice and give our clients an invaluable look at how their compound or medical device will fare with medical practitioners.
Chief Medical Officer, for young companies that lack a full-time, in-house medical department but need an experienced medical development leader.




		Medical Affairs & Strategic Development Our Medical Affairs and Strategic Development Practice guides emerging biotechnology, pharmaceutical, medical device and medical diagnostics companies through the entire product development process, from research and development through market approval. Our Medical Affairs professionals provide our clients with strategies that help maximize the commercial value of their product development programs. Our professionals have a proven track record of superior leadership and success in the management of clinical development programs. The Medical Affairs and Strategic Development Practice often serves as our clients' Medical Affairs Department, developing and facilitating research projects that support our clients' full medical-use and commercial objectives. This close working relationship ensures that our clients' research efforts are medically sound and meet current regulatory requirements. The Medical Affairs Practice provides our clients with: Medical and technical expertise, regarding the development program. Managerial oversight and leadership, to the clinical group implementing clinical trials and the project team to ensure that corporate milestones are reached. A liaison with potential clinical investigators and academia, to initiate clinical trials. Medical expertise, for selecting clinical investigators and sites, protocol and investigator brochure development, study and safety report writing and the writing of medical sections of regulatory applications. Medical monitoring, a safety review of data obtained during a clinical trial, the application of stopping rules and regulatory expertise regarding AEs/SAEs and reporting. Advisory board meetings with experts in the client's therapeutic field, which are conducted and chaired by the Medical Affairs Practice and give our clients an invaluable look at how their compound or medical device will fare with medical practitioners. Chief Medical Officer, for young companies that lack a full-time, in-house medical department but need an experienced medical development leader.