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:

Study Design, Protocol and Statistical Analysis Plan (SAP) Development

• • 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.
  • Develop a stand-alone statistical analysis plan, consistent with the study protocol, defining detailed statistical methods as apropos for pre-planned analyses, pre-specified criteria for intention-to-treat, per protocol, and safety cohorts, and pro forma table/figure/listing templates.
  • Review relevant aspects of case report form content and contribute to the creation of specifications for clinical data management and validation.

Ongoing Study Execution

• • Interim Analyses as pre-specified in the study protocol and/or the study statistical analysis plan
  • Ad hoc, exploratory analyses as you may require for the study to support interim evaluations, preliminary publications and presentations.
  • Collaboration with the sponsor, principal investigators/steering committee, and other parties as apropos to review study progress and other relevant operational considerations.

Post-Study Close Analyses and Publications

• • Collaborate with the sponsor, study authors and medical writers, to create analytic content for abstracts, posters, manuscripts and other presentations for meetings and journal submissions.
  • Generate analyses for sponsor internal utilization.

Post-Hoc Analyses of Prior Studies

• • In many cases, I have been approached by a study sponsor to provide analyses on studies that were performed in the past, where new opportunities to leverage the value in the data that are already available become evident. 
  • These are studies where I was not originally involved as the statistician, but can now bring my expertise to bear to provide new insights in collaboration with the sponsor, whether for internal use, or for publication related activities.

Sponsor and Investigator Meetings

• • These meetings may be in-person or virtual, as apropos.
  • I can provide critical insights into study data, interpretations of previous analyses and, in many cases, can engage in "live" analysis during the meeting to provide timely answers to questions that arise during discussions.