The end goal of any clinical trial is to obtain useful data that underscores the safety and/or efficacy of the drug, therapy, or device being assessed. To achieve this, validated processes are essential to carefully handle the data. This ensures potential issues can be identified early, and keeps data internally consistent throughout the study. 

Datapharm’s experienced staff can set up an Electronic Data Capture system for you to ensure all planned datapoints are collected. We use an efficient combination of automatic and manual methods to check the plausibility and accuracy of the entered data.

CDISC standards are becoming the industry standard for regulatory submissions. Our statisticians are familiar with CDISC formats and the necessary conversion of data, to allow the involved process in data conversion to be expedited for regulatory submission.

Part of having usable data is the ease with which it can be looked at. Datapharm is able to provide a study's database in any number of formats for analysis. In addition, user-friendly ICH-compliant data listings can be generated in pdf form for anyone to review during the study.

Make an enquiry

5 Takeaways: Data conversion

  1. The results of plausibility checks can be logged as a data query within an electronic data capture system to alert and communicate with site staff, and to track the status of the query from open to closed.
  2. Plausibility checks can inform what protocol deviations are logged - a full, final list is sent to the Sponsor of the project for their review before datalock.
  3. CDISC works closely with regulators all over the world to ensure their standards are appropriate for regulatory bodies, including the TGA, FDA, PMDA, and NMPA.
  4. Metadata is information that describes a particular database. This includes information about what each dataset contains, what each variable represents, and a data modification audit trail.
  5. The data listings are also included as Appendix 16.2 of a clinical study report as part of ICH GCP standards.


Fill out our form below and we'll get right back to you!