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
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