{"id":95798,"date":"2026-04-01T22:40:02","date_gmt":"2026-04-01T20:40:02","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=customer-stories&p=95798"},"modified":"2026-05-22T19:06:03","modified_gmt":"2026-05-22T17:06:03","slug":"itm-brings-study-training-in-house-to-stay-inspection-ready","status":"publish","type":"customer-stories","link":"https:\/\/www.veeva.com\/eu\/customer-stories\/itm-brings-study-training-in-house-to-stay-inspection-ready\/","title":{"rendered":"ITM"},"content":{"rendered":"

Biopharmas are seeking greater control over clinical operations to reduce regulatory risk, especially with the new ICH GCP E6(R3) guidelines<\/a> emphasizing enhanced sponsor oversight and comprehensive training for all clinical trial personnel. R3 holds sponsors responsible for making sure that all clinical research sites, contract research organizations (CROs), and functional service providers (FSPs) are adequately trained on GCP guidelines and trial protocols. It also places additional onus on investigators to provide training documentation for specific tasks outside the usual standard of care.<\/p>\n

\nBut, sponsors that rely heavily on outsourced models may struggle to stay in compliance. Outsourcing clinical study training often creates data silos, requiring significant manual effort to sync information and users across multiple, disparate clinical systems. These challenges led radiopharmaceutical development company ITM to rethink its training processes to ensure inspection readiness for internal and external staff. \u201cWe were nearing a NDA submission for our first radiopharmaceutical therapy and we didn\u2019t have a centralized training system to prove that product-specific training took place for ITM staff, or that our CRO staff were compliant,\u201d explains ITM\u2019s Head of Global Clinical Operations, Liz Coxon. \u201cWe started with eTMF ownership and now the next step is owning study training.\u201d\n<\/p>\n

\nITM implemented ³Ô¹Ï±¬ÁÏ Study Training<\/a> in September 2024 for internal staff, connecting with its existing ³Ô¹Ï±¬ÁÏ eTMF and moving away from the hybrid ownership approach the company previously had with its CRO. Now, ITM owns the technology, and they plan to have ITM and CRO staff work together in one system to administer training. \u201cWe needed to prove not only that training had taken place, but that the material had been understood,\u201d notes Coxon. \u201cOur training approach with ³Ô¹Ï±¬ÁÏ Study Training means we can determine whether read-and-understood tasks or training quizzes are required, based on pre-defined rules.\u201d\n<\/p>\n

\n\u201cOur training approach with ³Ô¹Ï±¬ÁÏ Study Training means we can determine whether read-and-understood tasks or training quizzes are required, based on pre-defined rules.\u201d
\n\u2013 Liz Coxon, head of global clinical operations, ITM<\/span>\n<\/p><\/blockquote>\n

\nSince going live:<\/p>\n