Medical monitors are continuously faced with challenges which can affect the trial outcome particularly with respect to patient safety. The key goal of the medical monitor is to identify areas which are relevant to volunteer safety and which eventually affect the Risk Based model for clinical trials. Our medical monitors are highly qualified, experienced and have the capabilities to look at safety related key aspects of your clinical trial programme. Our Monitors perform Source Data Verification (SDV), validating that the data in the Case Report Form (CRF) accurately reflects the source. To simplify this process COD actively embraces increasing use of electronic CRFs which has opened the door to alternatives that provide more efficiencies and cost advantages than the SDV approach.

At COD research, we utilize a central risk-based monitoring approach which improves monitoring cost-effectiveness without compromising quality and integrity with our standardized in in built technologies. COD clinical monitoring solutions is a platform which helps in identifying clinical trial related issues pro-actively, in-depth insight into patient data and can provide consolidated as well as customized data for all therapeutic areas of COD clinical trial conduct. Additionally, our technology oriented, Risk-Based Monitoring helps improve and enhancing clinical trial design, conduct, oversight, recording, and reporting, while ensuring human subject protection and reliability of trial results.

Our Benchmarks for Risk based Monitoring

We follow the published industry guidance, “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring published by the USFDA in 2013 for our Risk based monitoring services to our clients. Based on this guidance, COD research is able build a formal approach to quality management by embracing technology and leveraging access to real-time information to drive a more structured approach to risk in study conduct, of which monitoring is a critical element.

COD research ensures maximum compliance to the risk-based guidance provided by the USFDA, helps clients proactively manage risks, and keep their trials on track and on budget. We understand that just identifying risk in a clinical trial programme is not sufficient. There is an increasing need for data integrity, quality and patient safety in the clinical trial. For imparting the same we have an extended Risk based quality management approach (RBQM) system for our clients.

This system has the fundamental principle of Quality by Design Approach by looking at the clinical trail through a lifecycle lens. This approach takes into consideration only the key steps of the clinical trail monitoring programme which are specific, relevant and measurable.

Our Success stories in our Risk based monitoring services are primarily because we align with the 3 focus areas as per USFDA specifications:

• We do risk assessment conduct at both pre-study and ongoing during the trial.
• We prepare a well-articulated study protocol based on factors identified during this risk assessment
• We prepare a customized Risk based monitoring approach for our clients based on the Risk assessment and protocol.

We also monitor our internal RBQM strategy on an ongoing basis so that necessary changes and improvements can enhance quality, effectiveness and efficiency of clinical trials.