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PPCE carries out Clinical Data Management activities for paper-based, electronic data capture trials as well as hybrid studies.
We identify four important areas of difference between electronic and paper based studies:

- the manner in which data will be collected

- timelines necessary to prepare for the study

- the manner in which collected data will be verified, and

- disaster recovery planning.

Standard Operating Procedures (SOPs) followed by PPCE incorporate current applicable regulatory requirements and are audited on a regular basis for completeness, applicability and compliance. SOPs include requirements from the stage of protocol finalization, CRF design and database design and testing to data validation, discrepancy management, SAE reconciliation, QA and QC to database audit, lock and archiving.

Considering that the final goal of clinical data management is to allow for logical and accurate analysis of data, we pay particular attention to regulatory compliance.   21 CFR part 11, ICH-GCP and GCDMP requirements are built into operating procedures and checked at regular intervals to ensure that your clinical trial data is in safe hands.