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.”
Main MEDICAL MONITORING 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.
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.
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).
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
ARG Medical Monitoring works closely with Data Management during start-up, allowing our team to build a database that is more intuitive and efficient for sites. We have the end in mind at the beginning, asking: what data do we want in the CSR, in what form, and why?
These sessions allow the entire team (including PMs, CRAs, DMs, even Biostatisticians) to accumulate general knowledge about the indication. This allows for more informed decisions throughout the entire trial on every level.
ARG Medical Monitoring develops rapports with site Study Coordinators and Principal Investigators by directly communicating to ask and answer questions. These relationships make for a better trial over time.
ARG Medical Monitoring collaborates closely with team members across all departments with open lines of communication, something which is part of our organizational DNA.
Breadth of Study Knowledge
The same Medical Monitor does data reviews/safety narratives/TLF and CSR reviews, eliminating any type of siloed structure. Because ARG Medical Monitoring scrutinizes the data in-depth from the beginning, we can better provide guidance on all sorts of measures from safety to TLFs to the final CSR. This is incredibly helpful to sponsors when questions arise, especially toward the end of the study.
Medical Monitoring is part of the Core Project team that remains consistent from start-up to close-out.