Medical monitoring

Our medical monitors offer clinical trial oversight, strategic consulting and safety support

Our medical monitors are professional Medical Doctors with several years of experience in pharmaceutical medical positions.

The team responsibilities include detailed clinical study protocol review of inclusion/exclusion criteria, medication administration, lab tests and safety and review of Clinical Study Report and manuscript.
Regular training to the project management and CRA team generate confident on the field. Our medical monitoring team helps the project stay on track and deliver quality.

Services provided :

Verification of Subject eligibility with

Identification/review of safety issues (deviation, violation..)

Review of lab and medical alerts (ECG…)

Review and Reporting of AEs/SAEs

Final reconciliation of medical data

Regulatory submissions

Our medical monitors offer the following clinical trial oversight, strategic consulting and safety support including :

Providing medical review and input into key study documents, such as protocols, case report forms, clinical study reports, data analyses, and regulatory submissions

Assist the sites to assess patient eligibility and ongoing protocol/management issues

Reviewing all Serious Adverse Events (SAEs) and safety information

Recommending Key Opinion Leader (KOL) and Advisory Panel Networks

Providing representation at regulatory meetings

Get in touch

About us       |      Expertise      |      Services      |      Contact

Copyright © ExperTrials 2019  |  Privacy Policy  ​

Le Patio – 35/37 rue Louis Guérin – 69100 Villeurbanne (Lyon), France

+33 (0)4 20 10  62 16

Shopping Basket