Drug Safety and PV Services

When patient safety is of the utmost importance, Sponsors trust MMS as their go-to CRO.

We are very impressed with the quality of the MMS deliverables. Excellent improvement proposals!
Oncology Clinical Lead
Top 5 Pharma

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 clinical 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.

Suggested For You

perspectives

July 1st, 2025

Why Real-Time Data Access Matters (and How to Make the Most of It)

webinar

July 31st, 2025

Design, Data, and Decisions in Oncology Trials

perspectives

June 24th, 2025

Why Now Is the Time for Specialized, Data-Focused CRO Partners

news

June 19th, 2025

MMS Wins in the 2025 Fierce CRO Awards for Excellence in Client Service and Partnership and Dr. Uma Sharma Named CRO Champion 

perspectives

June 17th, 2025

Solving Data Complexity with Real-Time Insights, Predictive AI, and Smarter Decision-Making with Datacise

regulatory intelligence

June 16th, 2025

Key MedDRA Coding Gaps Highlighted at the ISCTM 2025 Scientific Meeting

perspectives

June 10th, 2025

Applying Artificial Intelligence (AI) and Real-World Evidence to Boost Efficiency in Patient Safety Narratives 

perspectives

June 3rd, 2025

Choosing the Right Strategy: Parallel, Sequential, and Staggered Regulatory Submissions 

news

May 28th, 2025

MMS Named Finalist for Fierce CRO Award in Excellence in Client Service and Partnership, CEO shortlisted for the CRO Champion Award 

perspectives

May 28th, 2025

A Season of Change: Why the REMS Industry Consortium Matters More Than Ever

perspectives

May 20th, 2025

Navigating FDA OMOR Meetings: A Comprehensive Guide to Type X, Y, and Z Meetings for OTC Drug Sponsors

perspectives

May 6th, 2025

Why Clinical Trial Simulation Is Reshaping Drug Development: A Q&A with Dr. Aiden Flynn