Late Phase Studies

I am pleased to offer the following services in a collaborative manner with you and your team. These services provide support for late phase observational studies (prospective or retrospective), late phase randomized studies, investigator initiated studies and post hoc analyses of prior studies:

Protocol Development Support – Develop key biostatistical components of the study protocol, including assisting with the specification of primary and secondary endpoints, writing statistical analysis plan and method sections, generating power and sample size estimates, defining randomization strategies, and other components as apropos.

Case Report Form Development Support – Review relevant aspects of case report form content and contribute to the creation of specifications for clinical data management and validation.

Interim, Final and Post Hoc Analyses – Conduct biostatistical analyses as pre-specified in the study protocol, the study statistical analysis plan (SAP) and/or ad hoc, exploratory analyses as you may require for the study. Post hoc analyses, sometimes performed years after a study has closed, can also be performed, even if I was not the original study statistician.

Publication Support – Collaborate with study authors and medical writers, to create analytic content for abstracts, posters, manuscripts and other presentations for meetings and/or journal submissions.

Statistical Analysis Plan Creation – Develop a stand-alone statistical analysis plan (SAP), consistent with the study protocol, defining detailed statistical methods as apropos for pre-planned analyses, pre-specified criteria for intention-to-treat, per protocol, as treated and safety cohorts, and pro forma table/figure/listing templates.

Sponsor and Investigator Meetings – Provide critical insights into study data, interpretations of previous analyses and in many cases, engage in live onsite analyses to provide timely answers to questions that arise.

Data Safety Monitoring Boards

Serve as the independent biostatistician for pharmaceutical and medical device clinical trials for regulatory submissions (e.g. Phase II/III IND and IDE studies), collaborating with the independent subject matter expert physicians, to support key discussions, reviews of interim data and study stopping rules, and the formulation of recommendations to the study sponsor during open and closed meeting sessions.

Other Consulting Services

Provide a wide range of ongoing, value-added consulting services addressing key research considerations such as study conduct, research issues/findings and protocol modifications. If you are in need of services that are not specifically mentioned above, please contact me so that we can discuss your requirements in detail.