ITM Brings Study Training In-House to Stay Inspection Ready

Biopharmas are seeking greater control over clinical operations to reduce regulatory risk, especially with the new ICH GCP E6(R3) guidelines 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.

But, 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. “We were nearing a NDA submission for our first radiopharmaceutical therapy and we didn’t have a centralized training system to prove that product-specific training took place for ITM staff, or that our CRO staff were compliant,” explains ITM’s Head of Global Clinical Operations, Liz Coxon. “We started with eTMF ownership and now the next step is owning study training.”

ITM implemented Veeva Study Training in September 2024 for internal staff, connecting with its existing Veeva 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. “We needed to prove not only that training had taken place, but that the material had been understood,” notes Coxon. “Our training approach with Veeva Study Training means we can determine whether read-and-understood tasks or training quizzes are required, based on pre-defined rules.”

“Our training approach with Veeva Study Training means we can determine whether read-and-understood tasks or training quizzes are required, based on pre-defined rules.” – Liz Coxon, head of global clinical operations, ITM

Since going live:

• >75% of ITM Study Training users report that they find the interface user-friendly
• >90% are satisfied with the tool

Already, 80% of users are completing training on time, and Coxon is confident that percentage will increase as ITM’s team further tailors training based on roles and responsibilities.

Automating study training with a digital matrix

“It was a challenge for CTAs to maintain training matrices for our study personnel,” explains Coxon. “With the Study Training digital matrix feature, CTAs are now equipped to automate study training assignments per study, using custom matrices they create directly in the platform.”

“With the Veeva Study Training digital matrix feature, CTAs are now equipped to automate study training assignments per study, using custom matrices they create directly in the platform.” – Liz Coxon, head of global clinical operations, ITM

CTAs can also create trial-specific curricula for all staff and identify essential documents or training materials for each role in the curricula up front. The link with Veeva eTMF allows for updates to training content and personnel information to be pulled through to the training system, reducing the risk of staff missing training. Veeva Study Training automatically tracks modifications to documents in Veeva eTMF, including protocol amendments, and signals when updated training is needed. This new process standardizes ITM’s training approach and improves inspection readiness.

Next steps for ITM

Looking ahead, ITM will standardize study-specific training for all study personnel and establish a central report for study team training to provide evidence to regulators. This unified reporting will provide full oversight and ensure compliance, while providing study staff with a consistent yet flexible learning environment that accounts for individual knowledge and experience. “We’ll be able to demonstrate that real-time training has taken place, that we have documented it appropriately, and that we have provided relevant training for all study personnel,” Coxon said.

Learn more about Veeva Study Training for streamlined and compliant study specific training.