Precision Oncology’s clinical data review services provide rigor and quality assurance to the data clean-up process and enhance the predictability of finalization of end data and “lock” of the database for filing.
Our clinical and data team uses “SMART Patient Profiles” to conduct ongoing review of eCRF data. They are “SMART” due to programmed edits that highlight areas of potential error in the profile to facilitate the quality of the review process. Quality issues are identified early and corrective actions are implemented without delay. Clinical data review ensures adherence to the protocol (including toxicity grading and response evaluation criteria) and provides early detection or correction of site training and compliance issues. Conducting detailed remote review of the data allows the monitors to be highly focused while on-site for targeted source verification and pre-identified areas of concern.
Some benefits of our clinical data review services are:
• Data clean-up can be done on an ongoing basis
• Ensures that the final data makes clinical sense
• Timely database locks and analyses
Insights and corrections in the following areas:
• Safety data
• Interim response
• Cross-patient trends