Drug Safety and Pharmacovigilance

When patient safety is of the utmost importance, sponsors trust MMS.

Licensed and experienced physicians and healthcare professionals at MMS give sponsors peace of mind.

Drug Safety and Pharmacovigilance

MMS provides comprehensive solutions to meet the pharmacovigilance and drug safety needs of the pharmaceutical industry today. An efficient, adaptable model enables increased productivity, enhances safety monitoring external reporting, and offers sponsors more time to focus on strategy rather than day-to-day processing activities.
Comprehensive safety services across all phases of clinical research include:

  • Implementation and Management of safety databases, including data migration services
  • Medical safety monitoring
  • 24/7 case management
  • Serious Adverse Event (SAE) management and expedited reporting
  • Ad hoc safety analyses and risk management
  • Signal detection
  • Annual reports, periodic safety update reports (PSURs), and expert reports
  • Labeling/CCDS support
  • Literature reviews

 

Medical Monitoring Services

Medical monitoring experts at MMS provide medical reviews and oversight of clinical trial activities across all phases of clinical research, including first-in-human trials. Experienced medical staff bring 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.

The MMS medical monitoring team adds value throughout the clinical trial process, including the evaluation and determination of the clinical implications of the study results.

 

Learn how these services fit into our Data Acceleration Model

Related Client Case Studies

Data Review of NCE

Learn the story of a sponsor who approached MMS with an increased incidence of tumors in a phase 3 study and how MMS assembled a team of oncologists to move the drug through approval with no additional label language. Download the case study

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