INTERNATIONAL CLINICAL RESEARCH GROUP WITH THE FOCUS ON MEDICAL MONITORING

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DRUG DEVELOPMENT

While medical monitoring is the core of our activities, we do have an integrated approach to drug development. This approach begins with helping the client select the next step in the development process based on existing preclinical and clinical data. Our specialists can accommodate activities including clinical trial design, biostatistics, clinical pharmacology, site selection and/or core lab selection, data analysis, and writing up the trial results.

MEDICAL MONITORING

Medical monitoring is essential for the success of any clinical trial or expanded access/compassionate use program. We provide all necessary aspects of medical monitoring, including: confirming the subjects’ eligibility, evaluating the data collected throughout the trial (medical history, concomitant medications, vital signs, physical examinations, lab results, ECG, imaging, etc.), supervising all trial-related medical procedures, evaluating and reporting any adverse events, and serving as a liaison between the client and the research site’s medical staff.

PHARMACOVIGILANCE

Our medical monitors work closely with the pharmacovigilance (i.e., drug safety) specialists to ensure that any adverse events in clinical trials and expanded access/compassionate use programs are thoroughly evaluated and correctly reported. 

 

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