Montrium Releases eTMF Navigator to Provide Greater Business Intelligence in Clinical Trials

Our business partner Montrium, Montreal, Canada, announced today the commercial release of the eTMF Navigator.

The eTMF Navigator leverages all of the information and documentation that surrounds your clinical trial and provides a visual, real-time, multi-dimensional view of TMF completeness.  Clinical users now have the ability to manage their ongoing studies directly in the navigator by updating artifacts, sites or country information from a single location.The eTMF Navigator leverages all of the information and documentation that surrounds your clinical trial and provides a visual, real-time, multi-dimensional view of TMF completeness.  Clinical users now have the ability to manage their ongoing studies directly in the navigator by updating artifacts, sites or country information from a single location.

Read more here: http://www.montrium.com/2016/04/montrium-releases-etmf-navigator-provide-greater-business-intelligence-clinical-trials

US-FDA Guidance for Industry Data Integrity and Compliance With CGMP

After MHRA and WHO have drafted their guidance documents on Data Integrity the US-FDA has published in April 2016 the Guidance for Industry for CGMP compliance (DRAFT Version).

The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practices. The guidance outlines US-FDA’s current thinking regarding the narrow scope and application of part 11 pending FDA’s reexamination of part 11 for 2003 as it applies to all FDA-regulated products.

Further reading / references:

Download at PDA the free code of conduct document for data integrity: Open External Link

For more information feel free to contact us at: talk@comes-services.com