With industry experience ranging between 12 and 20+ years, our expert statisticians can support sponsors in identifying optimal and risk-mitigated trial designs. They can also be a part of the sponsor team in defending protocols and statistical aspects of the study design in meetings and written responses to the regulatory bodies. Our experts are also well connected to highly experienced regulatory consultants including former FDA reviewers from the Oncology, Neurology and Medical devices sections who can help in planning and preparation of submission documents and meetings. Our key experiences around regulatory aspects include:

• Identifying and filling gaps in protocols, study design and statistical planning before regulatory submissions.
• Participation in regulatory communications and meetings as part of the sponsor team.
• Statistical planning and support for FDA’s Complex Innovative Design (CID) initiative.