Phase 2 / 3 / Registrational Studies: Designing and conducting Phase required Proof-Of-Concept (POC) or Registrational studies including establishing innovative statistical approaches and endpoint design

Protocol Development: Developing detailed study protocols that outline the study design, patient population, endpoints, and statistical analyses.

Regulatory Strategy: Engaging with regulatory authorities to ensure the study design meets the requirements for approval and addresses any feedback or concerns.

Patient Recruitment: Implementing strategies to ensure timely patient recruitment and retention, addressing potential barriers, and ensuring diversity in the study population.

Statistical Analysis: Overseeing rigorous statistical analyses to interpret study results accurately and support regulatory submissions.

New Drug Application (NDA)/Biologics License Application (BLA): Preparing and submitting comprehensive regulatory packages, including NDAs or BLAs, with all necessary clinical data, study reports, and supportive documents.

Regulatory Interactions: Engaging in ongoing communication with regulatory agencies throughout the submission and review process, addressing queries and providing additional data as needed.

Market Preparation: Collaborating with commercial, marketing, and medical affairs teams to develop strategies for market introduction and positioning of the drug.

Education and Training: Providing training and educational materials to healthcare providers to ensure they understand the drug’s benefits, usage, and safety profile.

Post-Marketing Surveillance: Implementing plans for post-marketing surveillance to monitor the drug’s safety and efficacy in the real-world setting and fulfill any regulatory commitments.