Clinical Development Consulting
Our professionals have a proven track record of superior leadership and success in the management of clinical development programs. Our Medical Affairs and Strategic Development group often serve as the Medical Affairs Department for our clients, developing and facilitating research projects that support full medical-use and commercial objectives for your clinical program. Our close working relationship ensures that our clients' research efforts are medically sound and meet current regulatory requirements.
Clinical Development Consulting Core Services:
- Medical and technical expertise on development programs.
- Managerial oversight and leadership to the clinical group implementing clinical trials and to the project teams to ensure that corporate milestones are reached.
- A liaison with potential clinical investigators and academia to conduct 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, safety review of clinical trial data, application of stopping rules and regulatory expertise regarding AEs/SAEs and reporting.
- Organizing Advisory board meetings.
- Chief Medical Officer for start-up companies that lack a full-time, in-house medical department but need an experienced medical development leader.