Clinical Trial Safety

Palleos pharmacovigilance specialists prepare high quality safety reports within allotted timelines

One thing is permanently paramount: the well-being of our patients

Contact Us

All studies are driven by patient safety as a priority. With over 54,000 patients recruited into our projects since 2005, we emphasize patient centricity principles at every stage of clinical trials. The Palleos pharmacovigilance and medical monitoring teams cover a range of safety tasks and responsibilities throughout each study.

Clinical Trial Safety and Reporting Services

Set up of PVG-specific processes and procedures

Collection, description and processing of serious adverse events data

Evaluation of safety data

Data entry and MedDRA coding

Medical review, quality control

Reporting to regulatory authorities and investigator sites about presumed SUSAR

Annual safety reports to regulatory authorities and investigator sites.

Pharmacovigilance

Prioritizing patient safety, we meticulously manage adverse events, adhering to all regulatory standards.

Our flexible safety processes tailor communication of patient safety data to sponsor needs.

Our comprehensive safety and pharmacovigilance services include:

Safety Management Plan
MedDRA Сoding
Safety oversight service
ICSR processing
Medical assessment of ICSRs
Electronic safety reporting via EudraVigilance
Development Safety Update Report (DSUR)
Medical review of individual and cumulative subject data

Safety Management Plan

MedDRA Сoding

Safety oversight service

ICSR processing

Medical assessment of ICSRs

Electronic safety reporting via EudraVigilance

Development Safety Update Report (DSUR)

Medical review of individual and cumulative subject data

Medical monitoring

Palleos medical monitoring services include:

Medical surveillance by experienced clinicians for patient safety and signal detection/interpretation
Quality control and approval of trial documents to comply with ethical standards and regulatory requirements
Training on specific medical topics by our medical experts team

"Drug development is a costly and time-consuming process. Therefore, it is vital to obtain all-encompassing information on drug safety to ensure its speedy marketing authorization and prevent unfavorable outcomes."