Try our Pharmacovigilance and Safety support to ensure patient protection and data integrity

Explore how we plan and monitor patient safety throughout your clinical trial and ensure that the proper safety procedures are in place.

Our primary concern at ExperTrials is the patient.

Patient safety is of paramount importance in clinical research and is a critical part of the clinical trial process.

To ensure patient protection as well as data integrity, our staff provides site level safety services through Adverse Events (AE) and Serious Adverse Events (SAE) monitoring and reporting, and thorough review of efficacy endpoint data.

Safety event reporting and pharmacovigilance are subject to severe regulatory oversight.

Pharmacovigilance services support the project team to adhere to safety standards that protect the identity and well-being of the trial participants.

When planning a clinical project, one of the most sensitive, and coincidentally most important issues, is the establishment of a secure, feasible, functional and effective safety reporting workflow.

A cornerstone of safeguarding patient well-being and the quality of care in clinical research is the collection and reporting of serious adverse events (SAEs).

Ensuring patient protection and data integrity is our priority : we plan and monitor patient safety throughout your clinical trial and guarantee that the proper safety procedures are in place.

Medical monitors work closely with the sponsor and sites to perform qualified medical reviews of e.g., SAEs/SUSARs as well as providing general oversight and immediate support when safety issues arise.

Our well-trained team has all the necessary credentials and experience to provide you with full-service safety support throughout your trial.

Our commitment of excellences is our asset in fulfilling the needs of rigor and accuracy accomplishing these activities.

Our Safety & Pharmacovigilance services include :

  • SAEs/SUSARs monitoring
  • Patient narratives
  • Annual safety reports and DSURs
  • Interim safety listings
  • SAEs reconciliation
  • Participation in Safety Advisory Board
  • Clinical trial risk management
  • Coding (MedDRA, WHO Drug) of adverse event information
  • Pharmacovigilance database
  • Eudravigilance registration

The accurate and timely capturing and reporting of SAE is a critical component of a successful trial. Ensuring proper safety reporting procedures to sites, Ethics Committees and competent regulatory authorities is of utmost importance in protecting subjects/patients as well as the integrity of the clinical study results. Therefore, ongoing safety analyses and reporting are vital and require vigilant attention to ensure all SAE are reported in accordance with ICH-GCP and local regulations.

Do you need some additional information concerning Pharmacovigilance and Safety? Get in touch with us

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