Medifodil- Smart Pharma Solutions

Protocol Development & Study Design

Custom clinical trial protocol design. Scientific and regulatory alignment for protocol approvals. Feasibility analysis and site selection strategy.

Clinical Data Management & Biostatistics

Custom clinical trial protocol design. Scientific and regulatory alignment for protocol approvals. Feasibility analysis and site selection strategy.

Site & Investigator Support

Site feasibility assessments and investigator training. End-to-end operational support for trial sites. Ensuring compliance with ICH-GCP and ethical guidelines.

Regulatory & Ethics Committee Submissions

Preparation of Clinical Trial Applications (CTAs). Submission support for Institutional Review Boards (IRBs) and Ethics Committees (ECs). Ensuring compliance with country-specific clinical trial regulations.

Real-World Evidence (RWE) & Post-Market Studies

Patient registry and observational study design. Data collection and analysis for real-world patient outcomes. Post-market surveillance to assess long-term safety and effectiveness.

Let’s Build a Smarter Pharma Future Together

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