Throughout the clinical development process, interactions with the regulatory authorities are strongly encouraged but the response timelines are often prohibitive and clinical development teams tend to stick to the strict minimum.
We’ve captured thousands of sponsor-FDA exchanges made accessible to you through a simple but smart search tool to help you better understand the agency’s expectations, prepare for scheduled meetings and optimize your clinical development strategy.
The growing complexity in study design is making clinical trials harder to execute and leading to significant challenges with study startup, recruitment and retention. Striking a balance between complexity and feasibility can help relieve the study’s burden on patients and sites.
We analyze historical data to define this balance and help guide your study design to its optimal point.
The CRO selection process takes months to complete and the results are often disappointing. Similarly identifying and assessing investigator sites is labor intensive and doesn’t always lead to good outcomes.
We’re continuously assessing a number of performance indicators on thousands of CROs and sites to be able to direct you towards the ones best-fitted for your study and keep your risk at a minimum. We then help you monitor them routinely to address any risk factors that may arise.