Medical Monitoring Services
We provide medical monitoring services and 24/7/365 medical support to clinical trial Sponsors, investigational sites and study teams. We provide strategic consultancy during the study design as well as continuous clinical and medical oversight throughout all phases of a clinical program.
Our team of drug safety physicians consists of licenced Medical Doctors (MDs) having a vast knowledge in a wide variety of therapeutic areas. Our medical monitoring experience covers different types of medicinal products, including small molecules, biologicals and advanced therapy medicinal products.
What is more, our medical monitoring services can be paired with our full service clinical safety solution to provide a single platform for medical and safety oversight in clinical trials.
Development of Medical Monitoring Plans
24/7 coverage medical monitoring
Acting as the medical point of contact for Investigators and sites
Continuous medical support on eligibility, issues or concerns
Review of laboratory findings
Serious Adverse Events (SAEs) and safety information review
Causality assessment discussions
Medical coding of AEs and medications (MedDRA, WHO Drug Dictionary)
Medical review of study documents and materials (protocols, CRF, data, listings, reports)