PLG effectively supports the management of identifying and evaluating adverse events
A robust drug, device, cosmetic, and dietary supplement safety case management process is necessary to identify and evaluate adverse events (AE) and properly report them to regulators. We have noticed that the most significant obstacle clients face in case management is the ever-expanding number of data sources to process.
We have developed strategies using various tools customized during the project’s implementation phases, ensuring that the final tools always meet relevant regulatory requirements (databases and forms).
In addition to case management for post-approval products, we manage cases for all phases of clinical trials and can support expanded access, named-patient, and compassionate use programs.
We have developed robust processes to meet the diverse criteria of the various health authorities worldwide.
We can also assist clients with selecting, implementing, and validating artificial intelligence solutions to enhance and streamline the case management process.
PLG’s portfolio of case management services contains the following:
- Safety database setup and configuration with EMA, MHRA, FDA, and Health Canada as required
- Eudravigilance and MHRA ICSR downloads and inclusion/exclusion analysis
- Medical literature monitoring (EMA – MLM), national competent authority (NCA), adverse event (AE), adverse drug reaction (ADR) download/ triage
- Data entry, quality control, and medical review of ICSRs
- Follow up directly with investigators, reporters, or consumers
- ICSR submission to EVWEB / MHRA / USFDA
- SUSAR submission to EVCTM
- SUE forms for cosmetic cases
- Local ICSR submission, ethics committee reporting for clinical trial cases
- XEVMPD update and maintenance
- Medical monitoring in clinical trials
Choose PLG as your case management provider to unlock a myriad of benefits
Our team comprises over 80 employees based in numerous countries (France, Germany, Italy, the UK, India, Mauritius, Romania, Tunisia, and others) who are data officers, case specialists, and medical advisers.
Our data officers are scientists with specific training in vigilance processes, and our case specialists are either pharmacists or have graduate science degrees in life science fields.
We also have in-house physicians to support the case processing teams and can act as medical monitors in clinical trials if required.
The case management team is adaptable and flexible to client needs and has experience in client environments with client-specific processes; we can alternatively implement in-house processes, supporting any of your case processing requirements.
KEY FIGURES :
100
clinical trial cases processed during the past three (3) years
60,000+
total cases processed, including initial phases and follow-up during the past three (3) years
Brochure
My name is Nicola Brown. I am one of the case management line of business directors, having been with PLG for over 7 years.” “I enjoy being part of a dynamic, fast-growing company where quality is paramount, and no two days are the same. We have been working to develop and implement new tools to ensure we can always strive to offer our clients the most efficient and cost-effective solutions for their case management needs.
Nicola Brown
Case Management Director, ProductLife Group
