From pre-application through post-approval, SDC has extensive experience facilitating communication for our clients with institutional review boards (IRBs), the FDA, and other regulatory authorities. Whether filing a submission or preparing for an upcoming regulatory meeting, our experienced team will offer our full support and representation to help our client’s program succeed. An example of this support is listed below:
Case Details
- Multicenter global EDC study with clinical duration of over 2 years
- Complex adaptive study design was developed balancing multiple objectives including time and cost constraints
- Enrollment of over 100 subjects with 14 study visits
Key Highlights
- SDC was intimately involved in developing a new clinical endpoint, inclusion/exclusion criteria and performing detailed power calculations
- Provided full client representation and support with regulatory agencies
- Study design and corresponding SAP were approved by multiple international regulatory agencies
- Seamless interaction with sponsor and multiple clinical operations groups