Versante’s Value in Regulatory Review Cycles
All of our clients face time constraints and financial pressures. They need to move through the FDA’s review process quickly and successfully; success in one regulatory review cycle can mean the difference between getting a good drug to market, or its failure.
The leadership of Versante has been actively involved in six drug submissions, and substantially contributed to two others, all of which have been ultimately approved by the FDA. Experience has shown us that during the execution of a clinical study, challenging issues can arise that could quickly transform a seemingly simple study into a complex one. Properly addressing these issues in a timely manner can be paramount to salvaging the study or saving valuable time during the regulatory approval process. Versante’s highly experienced leadership team’s philosophy of proactive and timely intervention has benefitted many of its clients when such situations have arisen.
Versante provides full support to the regulatory review process and very actively participates in the processes listed below.
Pre and Post Submission Activities:
Integrated Summaries of Safety (ISS) and Efficacy (ISE)
Preparation for FDA Advisory Panel Meetings (what if Scenarios and Analyses)
Subgroup analyses
Use of covariates
Exclusion of data/subjects not compliant with the protocol
Consistency across sites
Use of concomitant medications with potential therapeutic effects
Drug interactions
Other interventions and their effects
Specific safety concerns
Superior quality products and processes
Statistical Analysis and Reporting
Clinical Plan Development
Protocol Development and Study Design
Therapeutic Expertise Consultation
Data Management
Electronic Data Capture (EDC)
CDISC Conversion
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