Digitisation cuts development times, but many processes still incomplete

Posted on Sep 23 2015 - 9:05am by John Peters
RATING

The benefits of digitisation for life sciences organisations are highlighted in the Veeva 2015 Paperless TMF Survey: Annual Report.

 The benefits of digitisation for life sciences organisations are highlighted in the Veeva 2015 Paperless TMF Survey


The benefits of digitisation for life sciences organisations are highlighted in the Veeva 2015 Paperless TMF Survey

This shows that clinical operations are continuing to move away from paper processes for managing trial master files (TMF), with the proportion of organisations managing ‘most or all’ TMF documents on paper falling to 31%, from 43% last year.

There have also been advances in the next stage of digitisation – implementing electronic processes to manage the eTMF workflow.

One in four respondents now uses electronic trial master file (eTMF) applications to exchange TMF documents between sponsors and contract research organisations (CROs), up nine percentage points from 2014, and trial sponsors and CROs now rely considerably less on paper shipments and fax to exchange documents with sponsors, both down 10 percentage points in one year.

Survey respondents expect the use of an eTMF to manage study/site start-up and TMF filing to shorten development times, cited by 63% and 57% of respondents respectively. Half of all eTMF users (49%) and 61% of those using eTMF applications have improved their inspection readiness.

Users of eTMF applications are more than twice as likely (57%) to grant auditors and inspectors remote access to the TMF than respondents as a whole (26%).

The report also identifies gaps in many organisations’ electronic processes. Less than one third of respondents ‘mostly or always’ use electronic methods for signing documents (21%), the electronic creation of source documents (25%) or electronic collaboration with external partners (30%).

veeva.com/2015tmfsurvey

About the Author