Services and Areas of Expertise
Dr. Beasley’s combined medical and computer science background, along with his training in basic statistical analyses methods provides him with the ability to effectively communicate with and coordinate the activities of medical experts, data management scientists, and statisticians in the design, execution, analysis, interpretation of results, and reporting of complex studies with novel endpoints. His experience with large sets of safety data from complex development programs makes him well suited to the sensitive review of such safety data with an eye toward noting matters requiring focused, in-depth analyses. He can work well with the technical expert teams necessary for such activities and is well suited for interpreting the results of such work.
Key areas of consultation
Planning or Authorship of Reports and Manuscripts
Consultation on the planning of or primary authorship of regulatory reports of individual studies, integrated analyses, and post-hoc analyses for topics of special interest across multiple therapeutic areas as well as academic manuscripts in neuropsychopharmacology.
Study / Development Program Design
Consultation on individual study and/or development program design in neuropsychopharmacology. This service can include collaboration with your statisticians / statistical consultants on the design of the Statistical Analysis Plan; specific analyses; tables, listings, and figures; and the development and authoring of regulatory reports for individual studies and/or integrated development program results.
Consultation on Topics of Special Interest
Consultation on topics of special interest regarding the safety of a compound in development or an approved drug. This can include review of existing data or consultation on analyses designed to explore the specific topic of interest across multiple therapeutic areas.
Analysis
Consultation on methods for analyses of various safety data. Assistance with development and writing of the Statistical Analysis Plan for Safety and / or Efficacy for regulatory submissions.
Data review
Review of efficacy and/or safety data for a study and/or development program with regard to estimation of likelihood of technical success in development across multiple therapeutic areas.
Product Liability
Consultation on product liability matters related to safety.
Assistance in Preparation for Regulatory Advisory Committee Documents and Presentations
Review of Integrated Summary Documents (efficacy and safety) as well as summaries for Regulatory Advisory Committees in order to highlight areas of potential concern to regulators and / or Advisory Committee members and consultation on potential additional analyses with existing data that are intended to potentially mitigate such concerns.
