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.

Services Offered:

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)

Medical consultations

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Medical Monitoring Plans written
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24/7 safety and medical monitoring
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SUSAR and periodic reporting compliance

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