Medical Monitoring
Elevate your clinical trials with our Medical Monitoring services.
From the inception of study design to the release of the final clinical study report, we prioritize patient safety, uphold data integrity, and deliver unparalleled medical expertise and oversight.
Trust us to transform your clinical trial journey, ensuring the highest standards of care and precision throughout.
Integrated to clinical research, Medical Monitoring ensures patient safety and data integrity. In line with SOP MED001 and ICH-GCP, constant oversight safeguards patients and study data. Medical issues are identified, advised to Investigators, and escalated when needed. While Medical Monitoring advises on patient management, the ultimate responsibility lies with the Investigator.
OPIS Medical Monitors are Medical Doctors experienced in the planning and conduct of clinical trials and with deep knowledge of the indication under investigation, investigational products of the clinical trial, and the protocol procedures. Medical Monitor provides medical expertise and oversight for the clinical trial, from initial study design through final clinical study report release.
A detailed Medical Monitoring Plan is in place to describe details of the Medical Monitoring activities to be carried out for the study, including timelines, data listings to be used, protocol-specific events of interests, and any additional information that can have an impact on the Medical Monitoring activities.
The users can perform the following tasks:
Access to patient profiles and medical monitoring reports
Perform a medical review of clinical data
Generate and manage queries
eSign the clinical data reviewed
Print the PDF report
Safety Trends and Signal assessments are configurable, some examples are:
Enrolment / Randomization
Safety data
AEs / SAEs / Pregnancies / Deaths
Vital Signs and lab tests
Study drug compliance
Our Medical Monitoring tool seamlessly integrates with the Clinical.Net EDC (Electronic Data Capture) system, creating a cohesive ecosystem for clinical data management. This synergy ensures that clinical data monitoring and review become more efficient and effective than ever before. Ensuring data integrity and regulatory compliance are at the core of what we do. The MM tool is rigorously validated to meet the highest industry standards. Notably, it is 21 CFR Part 11 compliant, which is a critical milestone in demonstrating its robustness and trustworthiness.
The MM 24/7 is the dedicated platform offered by OPIS to deliver around-the-clock medical support to research sites.
Here’s how it works:
Learn more about our Modules!
