The team handles the following activities:
- Signal management
- Aggregate reports, including periodic benefit–risk evaluation reports (PBRERs) and periodic safety update reports (PSURs)
- Clinical expert statement (CES)
- CTD modules 2, 4 and 5
- Addendum to clinical overview (ACO)
- Risk management plan (RMP)
- Specific requests
- Responses to authorities
- Specific analyses
As demand has grown for medical writing services, PLG’s team has adapted its offerings with tools created specifically to optimize coordination and writing. Advanced tools offer automation that uses artificial intelligence to streamline and speed up processes—for example, the automation of certain listings, tables, and figures or the creation of alerts.
The medical writing team is composed of coordinators and medical writers, including physicians, pharmacists, and doctoral-level scientists. Our experts have many years of experience and extensive knowledge across multiple therapeutic categories and product portfolios and can adapt to the specific needs of each client.
PhD in biomedical science
Deep experience in and knowledge of the field of molecular and cellular biology and neuroimmune interactions.
Handles medical writing for full dossier and CTD preparation and medical affairs activities.
PhD in Biochemistry and Molecular Biology
Experience and knowledge in Oncology, Immunology and Target Therapy
Handles medical writing for full dossier preparation, aggregate reports and medical affairs activities.
Signal detection reports in 2020
PSUR in 2020
RMP in 2020
eCTD modules and ACO in 2020