Clinical Trial Management Systems in the World of Mergers and Acquisitions
when devising a system implementation plan is that it cannot impact any major milestones to our clinical programs. We would always have a plan in place that would defer certain trials if they were undergoing any kind of major milestones. But the business has been very proactive and we can plan deployments months in advance,” said Heider. Training was similarly planned to be absorbed without impacting any clinical commitments.
To assist with the implementation challenge Merck engaged Oracle Life Sciences Consulting. “They were selected due to their close alignment with the product,” Heider remarked. “Oracle’s consulting team also possessed a direct line to the software engineering side of Oracle and associated support teams.” These teams were crucial in leveraging Oracle’s extensive collection of consulting assets and accelerators, prioritizing tasks such as providing a patch for a point release. In addition to Oracle’s global team of product experts, a strong internal program management team was put in place to work on the Siebel CTMS implementation, providing the necessary domain expertise and in-depth experience. “Our data migration team was selected due to the previous experience gained with our legacy CTMS implementation.”
The success of the implementation strategy also depended greatly on the structure of the project team. Additionally, it was important that the team focused on three distinct phases: implementation, migration, and integration. A staged migration was agreed as the most appropriate strategic approach as it allowed the design configuration, testing, and deployment of a limited Siebel CTMS release to a subset of users, adding more functionality and enlarging the user base over time. According to Heider, “one country, Canada, was chosen to carry out preliminary live testing of which feedback was received and acted upon.” The feedback allowed Merck to address issues in the system with a point release before going live with the final wave. This experience also allowed the teams to quickly address issues in the system post-production before the majority of users were migrated.
Following the initial deployment and testing phase, the CTMS strategy will be deployed in four waves: local studies in Asia, European migration, and then the final waves will be US and global studies. The
rationale for having the US in the latter phases is because many of the global studies are managed from the US.
The phased approach also meant a training schedule for the Siebel CTMS and the merged eClinical trial management technology could be devised that would inform and educate intended users and personnel within the time constraints. End-users such as documentation specialists and database administrators needed to acquire the required Siebel knowledge and skills through training. “Most of the training parameters were dependent on the volume, and number of users,” explained Heider. “Sufficient analysis had to be initiated and tested to ensure that the process and the system were ready to launch for everybody.” In terms of training requirements, a staged migration allowed a staggered approach with internal training resources that met expected needs. From a logistical perspective, training users to an acceptable standard within the given timeframe proved a challenging task that carried with it a high degree of uncertainty. “Training approximately 2,000 people is not possible within a short space of time. Likewise, it would’ve been unwise to train people too far in advance otherwise the training goes stale and they would require a refresher,” explained Heider. Other factors to consider were the training materials that needed to be developed for each specific study that used the new system. Crucially, it was important to determine who would have the responsibility in creating and delivering training programs/materials, and the responsibility in maintaining training records.
CTMS solutions are becoming increasingly integrated within the eClinical infrastructure. Chris Heider sees the CTMS as “the glue that binds together all the other processes across the clinical organization. It tracks the status of all of your trials; it is the single source of the truth that can give management a good overview.”
At present, CTMS appears to be a technology that is now coming into its own, excelling as a vital enabling tool in the management of global clinical programs. Looking ahead, there is a strong case for the CTMS becoming the cornerstone in any pharmaceutical organization. n
THE POWER OF CTMS—INTEGRATION, INTEROPERABILITY, AND COLLABORATION
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