eCOA Sciences – Driving Best Practices, Regulatory Rigor and Data Integrity
eCOA science is rapidly evolving, and so are the regulatory frameworks that govern design and implementation practices.
YPrime’s eCOA consulting can support your eCOA implementation strategy with strategic counsel that reflects the most up-to-date practices and regulatory guidances. As members of the Critical Path Institute’s ePRO Consortium, we are actively involved in collaboration, development and dissemination of industry-wide best practice recommendations for electronic collection of clinical outcome data.
Consulting projects typically include:
- Solution design for complex outcome assessments
- Faithful migration practices and mode equivalence testing oversight
- Expert screen review to ensure psychometric equivalence of instruments when migrated to new platforms
- Customized strategies for therapeutic area and protocol-specific challenges
As the body of evidence supporting measurement equivalence of instruments using screen-based electronic formats continues to increase, many lingering questions remain on the appropriate amount of evidence needed to withstand regulatory scrutiny. Rely on YPrime’s eCOA scientists to help avoid unnecessary research and ensure your COA endpoint data quality meets global regulatory expectations.
When you need a reliable solution to ensure data integrity, look to YPrime’s data monitoring services.
Compliance is mission critical when eCOA data supports key endpoints. Data monitoring is a specialized service that provides an early warning system for pivotal studies to alert study teams before potential compliance risks escalate into liabilities. YPrime’s data science team applies targeted algorithms to enable rapid, automated eCOA data review that flags trends of interest or anomalies. It may also involve a combination of automation and clinical expertise for targeted, manual data review of select data points.
Within eCOA data sets, data monitoring can help identify compliance patterns that are below or near threshold levels, allowing for additional analysis to evaluate the scope and severity of the issue. Clinical expertise is available to assess the issue in the context of protocol requirements. YPrime’s clinical experts can help determine if the issue requires a formal data correction or if it can be addressed in downstream statistical analysis.
Data monitoring not only allows study teams to address current compliance or safety risks in real-time but also provides the ability to reduce future risks. It helps studies run more efficiently through identification of outliers, such as missing data, consistency of frequently collected data, query rates and site-level or patient-level protocol deviations. Higher sensitivity analytical capabilities can also identify patterns that indicate near-failure. Insights gained from data monitoring in real-world usage can lead to better protocol design in the future. Once enough data are gathered, predictive modeling can anticipate non-compliance situations and trigger preemptive actions.