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Pharmacovigilance and Medical Monitoring

ProSciento offers a comprehensive suite of services to monitor, assess and report on the safety and risk-benefit profile of investigational products.

Our pharmacovigilance and medical monitoring teams are healthcare professionals with extensive experience and training to effectively evaluate the safety profile of an asset throughout its development path. Our pharmacovigilance services are designed to ensure safety and migrate risk 24/7/360, working closely with sponsors, sites and regulators to foster an exceptional level of quality and compliance.

With the experience of more than 300 clinical trials for metabolic diseases and an unwavering focus on quality, we ensure that our clients have experts monitoring the safety and compliance of their clinical trial programs.

ProSciento’s comprehensive suite of pharmacovigilance services:

  • Customized safety surveillance
  • Safety plan development
  • Dedicated analysis and support for safety review committees
  • Causality assessment
  • Expedited regulatory reporting
  • Safety signal detection and management
  • Aggregate report management
  • Risk-benefit assessment
  • Adverse event coding and reporting
  • Call center function
  • Safety database services
  • Medical monitoring

ProSciento Pharmacovigilance Services
P: 619-863-5215, ext. 278
F: 619-781-9000
E: pvsafety@prosciento.com