Clinical Safety

Services

PVpharm supports sponsors, CROs, and biotech companies throughout the clinical development process, ensuring participant protection and regulatory compliance.

Our Clinical Safety services cover SAE and SUSAR management, medical monitoring, safety reporting, protocol review, DSUR preparation, and CTIS submission support. With a strong medical and regulatory foundation, we help safeguard the integrity of clinical trial safety data while offering a proactive and dependable partnership.

If you require specialised support for your clinical safety activities, PVpharm is ready to collaborate with you.

SAE and SUSAR Management

Medical Monitoring and Evaluation

Development Safety Update Reports (DSUR)

Safety Management Plan (SMP) and Investigator Brochure (IB)

Protocol Review and Safety Input

CTIS Portal Management

Legal Representation in the EU / Responsible Person in EudraVigilance

Sponsor Profile Registration in EudraVigilance

Clinical Safety Training

Support for Marketing Authorisation Applications (MAA)

Quality and Compliance in Clinical Safety