Proof of Concept & Pivotal

Proof of Concept & Pivotal

Proof of Concept (POC) & Pivotal Clinical Research

Design and implementation of proof-of-concept and pivotal clinical research rely on high-level statistical and medical experts as well as an efficient and stable clinical operations team. CR Medicon has integrated key resources to fully support such projects.

Integrated Services & Advantages

  • Statistical Expertise: Designs of proof-of-concept trials and pivotal trials are diverse and choosing which design to use is largely depending on statistical science. The CR Medicon team of statisticians have completed more than 50 FDA-delivered NDA filings. We provide expert consulting services through trial design, implementation, and reporting phases.
  • Drug safety and surveillance: CR Medicon’s independent PV team and experienced medical monitors handle incidents regarding drug adverse events in particular concerns to regulators.
  • Our clinical operations team is located across major cities in China and covers major clinical trial facilities; We use Medidata CTMS system and provide clinical audit and project management services that meet China’s ICH national regulatory requirements.
  • Our own biological sample analysis lab conducts population PK determination and analysis.
  • CR Medicon team has extensive experience in setting up and managing Independent Data Monitoring Committees (DMCs).
  • Provide unblinding services that meet regulatory requirements for double-blind trials.
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