Our Focus

We Specialize in oncology trials

We Are here to support Your trial

Medical Monitoring Solutions, LLC (MMS) is a clinical development consulting company that specializes in Oncology. We provide medical monitoring support to biotech companies of all sizes, and offer flexible hours that fit your needs.

Our medical monitors are oncologists and have extensive clinical experience in multiple indications. Our clinical scientists have been working exclusively in oncology trials and bring the data analysis and operational expertise needed to support the medical monitoring role. We can also provide clinical development strategic advice uniquely tailored to your programs.

Medical Monitor Oversight

Our Oncologists provide medical oversight and serve as the main point of contact to your team and sites.

CRF review/Design

We oversee the CRF design process at the beginning of the trial and make sure the CRF completion guidelines provide the appropriate guidance to sites to ensure clinical data integrity.

Investigator Meeting/ Site initiation visits

We can either attend and present at the meetings or support the preparation of medical monitoring slides.

Eligibility Review

Our clinical scientists will prepare the eligibility review form and our oncologists will review patient's eligibility prior to accepting a patient for participation in a trial. We either can provide a full medical review (includes review of redacted subject's medical records) or an abbreviated review of the most significant inclusion/exclusion criteria.

SAE Review

We can perform medical review of SAEs, assessment of relatedness and review of SAE narratives as well as perform reconciliation of clinical vs safety database.

Coding Review

Using MEdDRA our medical monitors will review the coding listings to ensure coded terms are appropriate and ensure consistency.

Protocol Development

We can either develop a synopsis from your concept or develop a full protocol from a synopsis. If you already have the protocol we will review it and do a quality check. We will also support the writing of future protocol amendments.

Safety and Efficacy listings medical Review

Our team will perform the medical review of as many listings are needed: AEs, Con Meds, Medical History, prior therapies, laboratory: Hematology, Chemistry, Coagulation, Urianalysis, ECGs, patient disposition, etc. We not only review safety listings but also efficacy listings, we have a radiologist on board for the review of RECIST listings.

24/7 Medical Coverage

At your request, MMS can make themselves available for emergency coverage for safety-related matters occurring outside of normal business hours, including weekends and holidays.

CRA and Site Support

MMS will provide therapeutic training to the team and answer any medical-related questions to CRAs or sites as needed.

CSR Review

We provide medical review of clinical study report at the end of the study.

Protocol Deviation Review

Our medical monitors will participate in the drafting of a. protocol deviation plan and deviation rules document to ensure protocol deviations are appropriately classified as major or minor deviations. MMS will review protocol deviation listings monthly to ensure consistency between sites..

We Will Help You Every Step Of The Way

Tell us about your project.