Case Processing
Our case processing services can help pharmaceutical companies identify incoming cases and verify their validity and seriousness. We have experts in a variety of areas who can assist with medical reviews and quickly and accurately identify adverse events to ensure they’re reported properly.
We have extensive experience in case processing and can help ensure you’re fully compliant with all legal requirements and regulations.
Regulatory Standards
As part of our case processing and management processes, we follow the E2B(R2) and E2B(R3) standards. We’re familiar with international regulations and can work with the:
- European Medicines Agency (EMA)
- Food and Drug Administration (FDA)
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Other international regulatory agencies
We use industry standard gateways and market-leading database software to ensure cases are handled quickly, accurately and in compliance with all relevant standards.
Our Process
We offer end-to-end case management, including data collection, case processing, medical evaluation and, where necessary, reporting adverse events.
Our case processing service follows a detailed workflow. Our experts will:
- Collect information about the case.
- Determine causality.
- Confirm listedness according to the product’s reference safety information.
- Identify any special situations (such as pregnancy, abuse or overdose).
- Carry out routine case reporting in the case of adverse events.
Where necessary, we can also work with other non-PV teams. For example, by liaising with study teams or your quality assurance department.
Why Choose Med Communications
At Med Communications, we have an experienced, multi-disciplinary pharmacovigilance team that includes medical experts, academics and pharmaceutical specialists. Our team is well-equipped to assist with PV services and to work with other departments and business partners.
We offer fast, efficient case processing services to help you maintain compliance and monitor adverse events, lack of effect issues, overdoses and other special cases.
Our team is experienced, efficient, reliable and able to provide scalable capacity. Whether you’re at the clinical trial stage, are entering post-marketing or planning a global expansion, we can work with you to help ensure regulatory compliance in both domestic and international markets.
Schedule a Consultation
To learn more about our case processing services and find out how Med Communications can help you with your compliance efforts, contact us today to schedule a no-obligation consultation.