Pharmacovigilance Services

Service Details

SDRL provides Pharmacovigilance services for product safety as part of pre- marketing and post-marketing of drugs. We have a dedicated team of trained Pharmacovigilance specialists and physicians who are experts in recognizing, processing, analyzing and reporting adverse events to provide high quality safety surveillance services during all phases of clinical development. Our team is highly familiar and up to date with local safety reporting requirements of different countries and are in compliance with 21 CFR part 11 and GCP standards for Pharmacovigilance.       The team brings expertise and proven tools to support your Pharmacovigilance program. Working closely with clients, our safety experts help organize, coordinate, and facilitate your surveillance activities. In every case, we work closely with epidemiologists to review the data to identify new trends and signals or to follow up on theoretical or actual safety concerns that have been previously identified. Pharmacovigilance Services include: Analyzing and reporting Serious Adverse Events (SAEs)and Unexpected Suspected SAEsAssessing the benefits and risks on an ongoing basisTrend analyses for safety parameters during the trialsData miningClassification and triage of casesQuality check of data entryMedical review of case reportsNarrative writing of case reports and submissions to regulatoryFollow up of case reportsSafety monitoring visitsVerification of case information and case lockPeriodic, annual and aggregate report writingPatient data managementOngoing data captureCapturing patient reported outcomeLetters to InvestigatorsPost-marketing surveillance services