The better a study is planned upfront, the smoother the study will run, to achieve maximum efficiency and minimal cost.
A day in my life at Clinipace
I support design and conduct of our clients' research studies, beginning with protocol development, then the Statistical Analysis Plan (SAP), clinical monitoring through our biostatistical presentation of collected clinical data, biostatistical analyses, and writing the final biostatistical reports that become part of the final Clinical Summary Report (CSR). I also am responsible for the development and conduct of each Data Safety and Monitoring Board (DSMB) and Independent Data Monitoring Committee (IDMC) that Clinipace runs for each client study requiring such support.
My "a-ha!" moment
As an original developer of the TEMPO system, I am gratified each day to see the system we envisioned over a decade ago now making a difference in improving efficiency and reducing costs associated with clinical research.
One of the biggest misconceptions I run up against in my daily duties is
A big misconception is that therapeutic experience is the only thing that matters when selecting a CRO or assigning a project team member. It is really operational knowledge and experience that make the difference. Yes, it is very helpful to be knowledgeable about a therapeutic area or class of drugs, especially when working in a complex therapeutic area. However, an experienced monitor or project manager can bring operational expertise to a project that transcends the need to have worked in the specific area before.
My #1 piece of advice when advising clients is
Plan as much as possible before beginning the study, consider all possible contingencies, and plan for them. Rushing into a study without proper planning generally leads to substantial problems and higher costs in the end.
American Statistical Association