- Clinical documents and Standard Operating Procedures (SOPs) development for Clinical Program
Clinical Development:
- Clinical Proposal Development
- Site Assessment
- Site Training
- Clinical Protocol Development
- Clinical Protocol reviewing and advising study sponsor and study team on protocol development, inclusion/exclusion criteria, and eligibility questions, protocol study design and halting rules for pediatric studies
- Clinical Protocol reviewing and advising study sponsor and study team on protocol development, inclusion/exclusion criteria, and eligibility questions, protocol study design and halting rules for studies in adults
- Informed Consent review
- Analysis of interim reports data
- Analysis of data for the Final Report
- Final report writing and review
Safety:
- Safety signal management and benefit risk assessment activities
- Regular and ad hoc review of existing and emerging aggregate safety data;
- Review and approval of safety sections of study protocols and informed consents documents
- Evaluation of adverse events (AEs) and serious adverse events (SAE)
- Review of SAE narratives and other safety reports
- Preparation of interim safety reports
- Medical assessment of individual Case Safety Reports (ICSR)
- Review of the FDA MedWatch Alerts and safety communicationsreview of the FDA MedWatch Alerts and safety communications
- Organizing and serving on Safety Monitoring Boards (SMEs) and Data and Safety Monitoring Boards (DSMB)