Pharmacovigilance

CST Holdings offers a comprehensive solution to meet the pharmacovigilance needs of industry today. Our efficient, adaptable model enables increased productivity for sponsors, enhances internal and external reporting, and offers sponsors more time to focus on strategy rather than day to day activities.

Comprehensive Safety Services:

• Management of safety databases including data migration services
• Medical Monitoring
• 24/7 case management
• SAE management and expedited reporting
• Ad hoc safety analyses and risk management
• Signal detection
• Annual reports
• Periodic safety update reports
• Expert reports
• Labeling/CCDS support
• Literature review

Medical Monitoring

MMS Medical Monitoring staff provides medical reviews and oversight of clinical trial activities across all phases of clinical research including first-in-man trials. Our Monitors have experience in a wide range of therapeutic areas and can provide services utilizing a variety of tools and technological platforms. Our medical staff brings a practical and real-world clinical perspective to assist study and sponsor teams with every aspect of subject safety. This includes ongoing collaboration with trial investigators, assisting with safety event reporting and the analysis, interpretation of efficacy, safety and outcomes data. Our team looks to add value through the clinical trial process including the evaluation and determination of the clinical implications of the study results.

Medical Monitoring List of Services:

• Drug Development planning including literature reviews and summaries to support scientific position and competitive analyses
• Medical review of clinical trial documents including Investigator Brochure, Protocol, CRF, Informed Consent, Safety Management Plan, data analysis plans, data validation plan, study reports, medical narratives and regulatory submissions
• Assist sites with decision regarding in/exclusion deviations, questions related to dosing or concomitant medication requests
• Site education including investigator meeting training related to disease states, trial efficacy or safety measures, treatment administration, protocol compliance, in/exclusion criteria, study procedures
• Patient emergency management including 24/7 coverage
• Review of study data listing including laboratory data, EKG, vitals and other safety data to ensure appropriate reporting of AEs or concordance with other critical data fields.
• Review of Medical Coding
• Medical review of the clinical database, flagging data for clarification by site
• Preparation of medical narratives, review and causality assessment of SAEs or events of special interest
• Trend analyses and signal detection during the trial
• Product safety including evaluation of relatedness and analysis of similar events for expedited cases