Set up
A Data Management Plan (DMP) serves as the foundation for every CHDR study. It outlines the data-related requirements and activities, ensuring the blinding, accuracy, integrity, consistency, reliability, and completeness of the collected data. The DMP also includes detailed timelines. Our team and the sponsor’s team work collaboratively to create and implement a DMP that complies with ICH-GCP guidelines.
Our study team will also develop a study-specific database by carefully translating the study's schedule of assessments into Promasys, a rigorous system validated through IQ/OQ/PQ in compliance with GAMP 5 and 21 CFR Part 11. This database includes all timepoints for each subject, with integrated validation checks to ensure accuracy. Before the study begins, the database undergoes a thorough review to guarantee the smooth execution of the trial. This meticulous process upholds data integrity and reliability, providing a robust foundation for successful study outcomes.
Conduct
At CHDR, we prioritise the accuracy, integrity, and security of data throughout the study process, ensuring that all data is complete, correct, and properly documented.
We use Promasys®, a validated protocol and clinical data management system, to efficiently collect and manage data. Promasys® maintains an audit trail of all data actions and enables prevention of unauthorised access and data protection through secure backup systems. User acceptance testing (UAT) is conducted to verify that databases fully meet the protocol requirements. Promasys® offers direct data entry as well as manual dual-entry of data from paper records, HL7 linkage (for safety lab data and ECGs), and import of data via load files (for example external lab data). Clinical trial data can be transferred to sponsors or third parties, with all transfers governed by Data Transfer Agreements (DTAs) to guarantee secure and compliant data sharing.
Our team conducts thorough reviews of both paper and electronic data collected during screening and study visits to ensure consistency and compliance with the study protocol, including judgement of laboratory results. We address queries promptly and perform extensive data checks before database lock, including generating blind data reports (BDR). Additionally, we review audit trails for potential process improvements.
CHDR also offers medical coding for adverse events, medical history, and concomitant medications, as well as SDTM and ADaM data conversion for regulatory submission.
After study completion, data is securely archived in Promasys® and removed or anonymised once the retention period has passed. Paper files are stored in a fireproof cabinet before being transferred to an external archive.
We ensure that all studies comply with protocols, SOPs, GCP guidelines, and regulatory requirements through continuous oversight by sponsor monitors.
With CHDR, you can trust that your clinical trial data is managed with precision, security, and full compliance.
Reporting & analysis
Once the clinical phase of a study is complete, our Data Management department ensures that all data is accurate and ready for analysis. At the time of study closure, we perform a database lock (DBL), which is carefully planned in alignment with the study timeline. This process involves ensuring that all relevant data has been entered, reviewed, and approved, with no missing or unresolved issues. We also conduct thorough data checks to verify quality and accuracy. If applicable, a statistician will generate a blind data report to assess pharmacodynamic variables, ensuring that any outlying data is handled without bias.
Through these steps, we ensure that the study data is complete, accurate, and ready for the next phase of analysis.
