PROFICIENCY CENTER
Independent Professional Peer Reviews
Scientists in the Technical Center have experience and are prepared to provide expert assessments of critical issues in:
- Preclinical development (e.g. directed pathology peer review, critical assessments of carcinogenicity, specific assessments of target organ toxicity, pharmacokinetic and toxicokinetic reviews)
- Clinical development (e.g. rationale for treatment approach, orphan drug documentation, analysis of specific patient populations, protocol review or development)
- Regulatory assistance for issue resolution with regulatory agenices worldwide (e.g., clinical hold documentation, preparation for advisory committee meetings, clinical expert consultations, and investigator's meetings)
Drug Development Documentation
Scientists in the Technical Center are experienced and are prepared to analyze and compile technical/regulatory documentation.
- Preclinical - Research Report Summaries, Non-Clinical Safety Assessments, Risk Management Plans, Adverse Event Reporting
- Clinical - Investigator's Brochures, Clinical Protocols, Clinical Expert Reviews
- Regulatory - IND/NDA Summaries, Regulatory Agency Interactions
- Pharmaceutical Sciences - CMC
