Clinical Development
I have a wealth of experience in protocol development and achieved proven track record in successful product registrations. I write protocols by leveraging strong therapeutic knowledge, as well as by engaging Key Opinion Leaders (KOLs), incorporating their clinical and academic expertise from the outset. Moreover, I work closely with trusted statisticians and pharmacokineticists to ensure the most optimal study design. I also take clinical practicalities into careful consideration during the drafting process in order to minimize protocol deviations during the course of the study.
Assessing study feasibility is also instrumental to the study design process. I am a natural researcher and make it my practice to carefully analyze prior product approvals to ensure that we build on known success factors and prior mistakes. In addition I conduct accurate feasibility studies and have a pool of experienced sites in my database for some key indications.
Clinical Operations
Throughout the course of my career, I have spent a lot of time mentoring and training CRAs, and I enjoy it.. Successful protocols are but one of many aspects fundamental to successful trials, and in my experience, study specific operational documents s are also essential to this process. I have extensive hands on operational experience and have created numerous key study documents in support of study compliance, such as IMP Manuals and Logs, Source Data Worksheets, Patient Diaries and Study Manuals to name but a few.