Dedicated to Ensuring the Quality and Scientific Integrity of Your Microbiology, Virology, Diagnostic, and Biomarker Data
There are many complexities in infectious diseases clinical trials. The absence of well-documented processes and systems to ensure the quality and scientific integrity of study data poses a significant risk for delays and added costs to your trial. To avoid these risks, Medpace invests in a unique Data Integrity Unit — a team comprised of highly trained microbiology specialists that provide ongoing evaluation and oversight of the microbiology aspects of infectious diseases studies.
Cross-Functional Collaboration
Integrated seamlessly into all aspects of the study from startup to close out, the Data Integrity Unit ensures cross-functional operational processes are exhibiting optimal productivity. They are dedicated to collaborating with the clinical team ensuring the protocol is maximally operationalized to capture appropriate microbiology, virology, diagnostic, and biomarker data for comprehensive study outcome evaluation.
Operational Oversight, Training, and Data Reviews
The Data Integrity Unit provides an additional level of operational oversight to infectious diseases trials, engaging in key document reviews to certify the inclusion of all procedures for endpoint data collection and analysis. The team works closely with Clinical Trial Managers and the study’s medical team during feasibility to assess epidemiology and provide updates on epidemiology. The team also assists during site selection and in assessing site and local laboratories’ capabilities to meet the study’s requirements. Serving as liaison with local and central labs, the Data Integrity Unit facilitates start-up and ensures proper execution of the study.
Additionally, the Data Integrity Unit develops and delivers training presentations and materials to ensure the study team, laboratories, and sites are equipped to seamlessly execute the trial. These trainings include scientific and study specific training for study teams involved, along with laboratory and endpoint training for the study site and local laboratory teams. Study specific microbiology data entry trainings are prepared for the sites to ensure capturing accurate data.
Finally, comprehensive data reviews are a key aspect of the role of the Data Integrity Unit, proving ongoing real-time review of study microbiology, virology, diagnostic, and biomarker laboratory data. The team provides weekly reports to the study team outlining the patient populations metrics, along with suggested study team action for identified issues. The proactive approach in monitoring study data and populations on an ongoing basis is essential to quickly identify trends or issues in the study while providing mitigations early on before they negatively impact the study’s data quality.
