During Oracle Health Sciences Connect 2021 this week, some Oracle clients have been sharing why they decided that after 20 or so years using InForm, it was time to transition to Clinical One.
The technical drivers for making this move include moving off antiquated architecture to a SaaS model with automated system upgrades. The business drivers include the need for efficiency in study build (for both data capture and RTSM) and being able to rapidly make study changes when requested by sponsors. Being responsive to client needs is clearly essential for CROs, whether that be in using a variety of available systems or in promptly implementing protocol amendments mid-study.
The deciding factors in selecting Clinical One as the new EDC and RTSM system included:
- Efficiencies to be gained by having EDC, Randomisation and Supply Management functionality all in one system
- Ease of study build and testing
- Ease of post-production changes for EDC or for RTSM functionality (e.g., implementing a new cohort in RTSM within 1 week)
The technical training available for Clinical One is interactive and really engaging, with the opportunity to work hands-on in the system throughout. For site users, the ability to take just-in-time training on-demand will clearly be beneficial.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
Currently, multiple companies are piloting Clinical One and working with the Oracle product development team to discuss potential enhancements, as are we at Perficient. Being early adopters can provide opportunities to influence the functionality and future roadmap of a system. The impact of collaborating with Oracle can be seen in the new or amended Clinical One features released each quarter.
While there are pros and cons to quarterly releases for a unified platform, companies will need to determine their strategy for handling them. Processes will need to be implemented to review the release notes for upcoming new features and determine which functions they will implement for ongoing or new clinical trials. This will undoubtedly mean more regular validation activities, but these should be smaller in effort than the large system upgrade and validation projects required for traditionally siloed systems.
There is much to consider when implementing a clinical development platform, and it is clear that companies will require support throughout their journey. That support can include:
- Selecting a platform
- Developing a phased roadmap to transition from multiple siloed systems to a single platform
- Updating study set-up processes to realize the benefits of a platform
- Organizational change management to prepare teams for the change and enable them to learn
- Technical support with functionality
It was interesting to hear about the experiences of Clinical One early adopters. At Perficient, we look forward to supporting more companies with their clinical development platform implementation journeys.
The Clinical Development Platform Dilemma
Interest in clinical development platforms is picking up steam. And for the right reasons. These platforms substitute multiple disparate point applications – such as electronic data capture, trials management, randomization, and pharmacovigilance systems – with one unified solution.
But is a clinical development platform right for you, and if so, which one?
Download our perspective to learn the:
- Brief history of clinical platforms
- Potential challenges
- Questions to ask before and during your search
- How Perficient can help