Interactions with Regulatory Agencies:
Procedural and In-person
Collaboration between sponsors and regulatory agencies is essential for the success of a clinical drug development program. This process begins with filing the IND and continues with an end-of-Phase 2 meeting. Then the requisite a pre-filing meeting, responses to regulatory queries, often there's an Advisory Committee Meeting, label-options discussions, adjunct or any on-going related studies and then the addressing of post-marketing commitments.
Cytel has clinical trial statisticians with extensive experience in regulatory settings. As you prepare for your regulatory interactions, our statistical consultants are here to provide knowledge and guidance.
Each statistician is highly knowledgeable about relevant and emerging methods associated with clinical trials and can articulate complex statistical issues to both non-statisticians and regulatory reviewers. We are available for all phases of drug, biologic and medical device development.
Cytel is versed in the rigors of designing and implementing better clinical trials.
In every phase of development we've helped trial sponsors in oncology, cardio-vascular, CNS, gastro-intestinal, Diabetes, metabolic disorders, inflammatory, pain, psychiatric, rare/orphan diseases, and medical devices more rapidly bring their trials to successful completion.
Every Cytel adaptive trial design submitted for review by regulators has been deemed acceptable.