According to International Conference on Harmonization Good Clinical Practice (ICH GCP), all study-related documents should be stored for at least of 2 years after the last marketing application approval in an ICH region or for a minimum of 2 years from the formal discontinuation of the investigational product clinical development.
In many cases the exact date of drug registration is not available, and CROs and Depots have to store large volumes of paper documentation for a longer period (up to 15 years). In many cases such volumes of clinical trial documentation can be significant and exceed typical office space capabilities. Each file should be identified and ready for submission in case of clinical trial audit or regulatory inspection. Sometimes the activities related to archiving are too laborious to be performed internally and this is where COREX archiving services can be of great value.
COREX archiving services offer special light and humidity control and intensified fire prevention system, they also include all the necessary procedures connected with e-document preparation, identification and access control. COREX offers real-time online access to the scans of the archived documents and access to the originals from the archive that can be sent to the client on the same business day.
corex process approach
- 1 PROJECT CLOSE OUT Close out meeting, analysis of successes and pitfalls.
- 2 ARCHIVING Structured approach to documents’ indexation and storage.
- 3 E-COPYING AND SCANNING Identification of the documents, naming, scanning and uploading to COREX WMS.
- 4 LONG-TERM STORAGE Access allocation, filing and specialized light- and humidity-controlled storage.
- 5 ACCESS TO FILES Sharing access details for downloading the documents from COREX WMS.