Medical Monitoring / Medical Review

We have put some of our most experienced people on Medical Monitoring/Medical Review of clinical trial data and offer this also as a stand-alone service. All are medical doctors with up to 10 years previous experience as CRA. Our clients are deeply appreciative of outsourcing this responsibility to persons completely independent from a specific project and preferably located in a different country with different language and different medical culture. This makes sure that results are understood by any Data Management Department.

covers CRF Data Checks which cannot be programmed or coded adequately by Data Management (e.g. text entries, diagnosis, treatments, AE`s and SAE`s, AESI)

checks medical data for plausibility and consistency on an ongoing basis

runs in parallel to regular programmable data checks

includes review of supplemental clinical trial data documents with medical content

advices data manager if required

reviews medical data before database closure