Safety Surveillance

Theorem Clinical Research has the experienced data professionals you need to develop an effective pharmacovigilance program. Using the Oracle™ Adverse Event Reporting System, Theorem provides comprehensive clinical and post-marketing adverse event (AE) and serious adverse event (SAE) reporting, including post-marketing coverage.

Our global multidisciplinary and multilingual team of physicians, PharmDs, RNs and other health care professionals are well versed on each project’s objectives and protocols, as well as all drugs and devices involved with a study. We are prepared to receive reports in more than 30 countries and in five time zones around the world. We also offer dedicated phone and fax lines enabling you to personally contact a safety officer in your region and time zone.

Safety Surveillance Services

• Non-serious and Serious Adverse Event Case Processing
• Data Entry, MedDRA and WHO-DD Coding
• SAE Narrative Writing
• Physician Medical Review
• Generation of MedWatch 3500A/CIOMS I Forms
• Preparation of Reports
• Periodic Safety Update Reports (PSURs)
• Periodic Adverse Drug Experience Reports (PADERs)
• EU Annual Safety Report (EASR)
• Pre- and Post-clinical Risk Management Plans (EU RMPs)
• Management of Investigational New Drug (IND) and Compassionate Use Programs
• Pharmacovigilance Plans for Marketing Applications
• Risk Minimization Action Plan (RiskMAP)
• Risk Evaluation and Mitigation Strategy (REMS)
• Risk Management Plans
• Epidemiologic Analysis
• Signal Detection of Safety Data
• Scientific Literature Review
• Safety Data Reconciliation
• Establishment of Database Systems and Standard Operating Procedures (SOPs)
• Assessment of Safety Systems and Processes
• Temporary Staffing