MEDICAL AFFAIRS & SAFETY SERVICES
The CRMG medical affairs and safety team offers a variety of services to enable your organization to meet or complement your overall medical monitoring and safety oversight needs. Our medical affairs and safety team is managed by an actively US licensed physician with over 24 years of clinical research and drug development experience who holds an active license to practice medicine in the United States.
Our core competencies encompass general safety surveillance compliance with current good clinical practice (GCP) standards and therapeutically experienced medical monitors matched to your study’s needs. In addition, we offer all aspects of regulatory safety reporting to the US FDA and other competent authorities.
Moreover, the CRMG medical affairs team can provide you and your investigative sites expert know-how and assistance with protocol development and execution. We offer thoughtful and intelligent responses to study-site initiated questions related to study entry criteria and other questions pertaining to safety.
In addition, CRMG offers physician review of all safety narratives associated with serious adverse event reporting, review of adverse event, laboratory and ECG data, and when indicated, interaction with data monitoring committees (DMCs) and data safety monitoring boards (DSMBs).
Specifically, our medical affairs and Safety Services include:
- Medical monitoring and plan development
- Safety review plan development
- Processing and safety database entering of adverse events (AEs) and serious adverse events (SAEs) into the safety database
- Drafting of detailed case narratives with strict medical oversight
- Preparation of necessary safety reporting forms for the regulatory authorities (MedWatch, CIOMS etc.)
- Preparation of periodic safety reports (DSURs, SUSARs, PSURs and PADERs)
- Reconciliation of SAE and clinical trial AE data
- Medical QC of coding terms using the latest versions of MedDRA (Medical Dictionary for Regulatory Activities) and WHODD (World Health Organization’s Drug Directory)
- Third-party vendor selection and management of safety databases
CRMG’s medical affairs team offers in-depth knowledge and experience across a wide spectrum of therapeutic areas with both in-house medical personnel and an established network of specialized clinical experts. Our clinical trial experience ranges from translational medicine to supporting all phases of pre- and post-registration clinical trials in both adult and pediatric subject populations. Further, our medical team will provide medical and scientific input and expert review on all types of regulatory submissions or scientific publications.
CRMG is well acquainted with and positioned to work across a variety of state-of-the-art, 21 CFR Part 11 compliant, electronic safety platforms & modules. Our experience with these systems provides our customers comfort that compliance will be achieved with the required electronic safety reports for regulatory filings and other tailored electronic outputs, and enables our clients to have in-house oversight of 'real-time' safety data.