Medical and Safety
ClinPro Trials global pharmacovigilance team consists of experienced healthcare professionals (PharmD, Nurses, Medical Doctors, etc.). Our mission is to serve as a collaborative pharmacovigilance partner, helping our clients improve patient health and safety. Our professional team has wide experience across a broad range of therapeutic areas, ensuring safety and consistency throughout your clinical trials. We can help you with the following:
Development of the Safety Management Plan(SMP) inclusive of outlining the safety management responsibilities between ClinPro Trials and the sponsor.The safety team at ClinPro Trials, will partner with you to create an SMP document that includes a Development Risk Management Plan, Safety Monitoring Plan, and other post marketing safety documents. We work together with your team to minimize compliance gaps and to create efficiencies in managing your safety data.Our experts follow the latest industry trends requiring a more proactive approach to pre- and post-clinical safety surveillance activities to ensure patient safety throughout the drug development lifecycle.
- Safety Adverse Event (SAE) Management
- Oversight of safety in the study and continual evaluation of safety data
- Medical oversight and evaluation of SAEs
- Review of coding and safety data listings and tables
- Review of coding and safety data listings and tables
- Completion of MedWatch/CIOMS forms
- Project-specific and therapeutic-area training to ClinPro Trials team members
- Review of safety and I/E criteria
- Protocol deviation review and management
- Completion of MedWatch/CIOMS forms
ClinPro Trials has a deep understanding of safety databases, with comprehensive expertise in ARISg, AERS, ARGUS, and others.
- Pharmacovigilance in Europe
- Eudra Vigilance Registration
- EV WEB Portal Registration
- European Suspected Unexpected Serious Adverse Reaction (SUSAR) Submission
- Qualified Person Responsible for Pharmacovigilance (QPPV) surveillance