Medical Monitoring in Clinical Trials

We Understand Your Medical Monitoring Challenges:

  • Does your Medical Monitor thoroughly review all your data?
  • Does your Medical Monitor bring a spirit of curiosity to the project?
  • Does your Medical Monitor infuse the study with a sense of practicality?
  • Does your Medical Monitor engage in proactive communication?

Proactive and Practical Medical Oversight of Your Clinical Trial​

Each of ARG’s full suite of service offerings is driven by the same ideal: individualized customer service. This is certainly true with Medical Monitoring, as we continually pose the question: “What is important here in this particular study?” ARG Medical Monitoring is engaged and communicative both internally and externally, going beyond simply answering questions. Our Medical Monitors take an ownership role in projects, reviewing the totality of the data, not just pieces of it. And because ARG Medical Monitoring takes both a broad and granular view of every clinical trial from start-up to close-out, we are able to infuse the study with medical expertise, clinical curiosity and a commitment to subject safety.

“My co-workers are amazing people and I’m always impressed by their professionalism as well as their clinical trial knowledge.”

“Being involved in everything from protocol design to study planning, to trouble shooting problems as they arise, to the final steps of CSR review gives the MM a unique perspective on the study and it’s data.”

Jen Prichard, MD, Medical Monitoring

Main Clinical Operations Offerings

Medical Data Listing Reviews
A review of data listings (typically Medical History, Concomitant Medications and Adverse Events, but involves other key information depending on the study such as laboratory results or physical exam findings). This is one of the most valuable functions of a MM. This ensures accurate data is collected throughout the study as well as improving subject safety by monitoring for safety signals.

SAE Review
ARG performs 100% review of each ICSR including a review of all source documents provided, coding of event terms, assessment of expectedness and relatedness, narrative review and query generation.

TLF and CSR Review
Involvement in review of TLF mock-ups is very important as issues can be identified early in the process. With a broad overview and understanding of the study data, the MM can be an invaluable asset throughout the CSR process.

Eligibility Review
A formal review of each subject to ensure they meet inclusion/exclusion criteria prior to study enrollment. This is especially important in some rare disease trials to ensure enrollment of an appropriate study population, or in trials where there are multiple or complicated exclusion criteria to ensure subject safety (such as multiple possible medication interactions).

Coding Review
A review of coded terms for accuracy and consistency. This is an invaluable service when done regularly throughout the trial. It creates very clean data which allows timely database lock (since the queries are addressed throughout the trial and not just at the end) and for better representation in the final tables due to appropriate coding consistency.

The ARG Difference