ProSciento has a dedicated team of clinical monitoring specialists broadly positioned geographically. They are extensively trained in metabolic study procedures and regulatory requirements to proactively identify and mitigate trial risks.
Our Clinical Research Associates (CRAs) ensure that all critical activities meet sponsor and ProSciento expectations and are delivered in accordance with the trial protocol, standard operating procedures (SOPs), ICH/GCP guidelines, and all applicable regulatory requirements.
ProSciento’s Clinical Monitoring Services:
- Rigorous study-specific CRA preparation, including site feasibility assessments, document collection and review, and clinical status tracking
- Continuous Risk Contingency Assessments (RCA)
- Real-time, secure data via electronic study-specific functional systems, including Medidata, IBM Clinical, Inform, CTMS and IWRS