Effective Data management plays a critical role in the conduct of clinical trials. Clinical research requires quality data sets for any conclusions to be valid. Questionable information does not allow researchers to ensure patient safety or make timely decisions, especially important in early phase trials. Clinical research organizations (CROs) and Sponsors have gone to great lengths to enhance the capabilities and technologies within their own data management groups. There is a plethora of different clinical trial data collection and analysis tools devoted to improving insights, but at Pharm-Olam, we discovered that the best resource and/or tool we have is our Medical Data Reviewer or MDR.
What is a Medical Data Reviewer?
The MDR adds another layer of data cleaning to our experienced Medical Monitors, CRAs, and Data Managers. We find that having a medical expert skilled in our data process and tools provides a much deeper clinical understanding of a therapeutic area and supports that nothing of clinical importance is missed within the data.
What Does a Medical Data Reviewer Do?
Medical Data Reviewers monitor all of the data collected in the course of a clinical trial. This individual performs a holistic review of safety data including Adverse Events, Prior and Concomitant Medications, Medical History, Physical Exam, Laboratory Data, Prior and Concomitant Procedures, and other safety components. This dedicated function allows him or her to identify any potential adverse events, prohibited medications, or out-of-range safety lab values within the data. MDRs also consider the data collected in light of the review guidelines in place for specific drug mechanisms or therapeutic areas. The individual highlights discrepancies and information that simply does not make sense given the study protocol and queries researchers directly so the issues can be resolved. They flag this for the study team (medical monitor, clinical and data management) and sponsor for further investigation and follow-up.
How Does Having an MDR Improve Research?
The Medical Data Reviewer improves research at a fundamental level. This person is involved in CRF design, SAE Reconciliation, Patient Profile development, Medical Coding UAT and Coding Consistency Review from the ground up. This hands-on focus allows the MDR to highlight medical trends at an earlier stage in our studies due to the development of sophisticated exception listings and continued quality oversight of Data Management cleaning activities. The inclusion of an MDR in study design also streamlines study processes by ensuring timely delivery of the clinical research data, helping to maintain protocol timelines.
The Pharm-Olam Difference
Pharm-Olam Data Management understands the criticality of your study data. We treat your data with the utmost respect and our team is always dedicated to finding new and better ways to help you meet your study objectives while delivering quality data to support your decision making. Managing clinical research data more efficiently and effectively is a big part of our operational excellence. Employing dedicated Medical Data Reviewers for each study is one of the ways that help Pharm-Olam go the distance in helping you create a healthier world.
Co-Authored by Zahida Bano