As the industry and organizations' experience with risk-based monitoring and quality management in clinical trials matures, we're seeing a shift in the type of RBM systems being used. While custom-built systems were once many sponsors' go-to solution, we're increasingly seeing the use of off-the-shelf, cloud-based software, otherwise known as Software as a Service, or SaaS. (Disclaimer: Good news to us. Bioclinica offers a SaaS-based RBM solution, ClearSite.)
So why is RBM SaaS picking-up speed?
Leading sponsors and pharma companies I've spoken with in all corners of the globe in recent months give a variety of reasons. Innovation; automation; advantages of leveraging existing data and systems; and reduced project and clinical resource burn are among the top ones consistently given.
But for sponsors considering implementing RBM SaaS for the first time – there's a big caution here – one that can be easily overlooked when so many other considerations and features are at hand. Never forget compliance rests on your shoulders at all times – not the technology vendor's. This is true regardless of where your data is hosted. Sponsors must be especially cautious to be certain the RBM software is validated, complies with regulations, performs as intended in a GxP-regulated environment, and that data handling processes and workflows meet all applicable standards.
Additionally, SOPs must be in place by the sponsor for managing data entry, access and reporting. Regulators also expect that the RBM system continuously be validated, something that can be difficult to do as end users generally have little or no control over the timing of system update releases. Hence the sponsor is responsible for ensuring that after each release, the system remains in a validated state. Despite this requirement, many sponsors are behind in their ability to address validation requirements. And security, compliance and impact on business processes only compound these challenges.
For these reasons and more, I tend to recommend that sponsors carefully evaluate RBM systems, not only on features and functionality, but also in the context of ability to support cloud and other challenges. Ideally a sponsor is able to share the compliance burden with their vendor and have ready access to services of a team well-versed in RBM.
You can head-off validation and other issues by asking vendors some critical discovery questions.
Keys in RBM SaaS Vendor Evaluation
- What is your experience with GxP applications?
- How much experience do you have in regulatory audits?
- Is your staff trained on HIPAA, PHI and security standards?
- How will our data remain secure?
Assessing the RBM SaaS Vendor Release Process
- How often do software releases occur?
- Does the vendor perform a release impact analysis?
- Do you have a process in place to achieve UAT before release? If so, describe.
- What happens if UAT is not completed prior to release?
- What validation support if any is available to assist us in managing release validations?
An RBM SaaS vendor should have solid answers to each of the above. They should also be able to demonstrate a level of experience, expertise and regulatory compliance track record on par with that of the sponsor.
More qualified vendors will formally evaluate the change requirements associated with a release and its business impact on the validated state of their client's systems. This includes an examination of system functionality subject to regulatory oversight. Resulting documentation can then serve as a starting point for the sponsor to conduct its own evaluation of system changes associated with the release. In addition to assessing changes to specific business processes and documentation, the sponsor's internal review also helps ensure documentation is able to stand up to regulatory scrutiny.
While it's easy to become dazzled by system features, remember to keep these things like the release process and surrounding timelines and documentation in the fore during RBM SaaS evaluation. This can go a long way to heading-off validation and other headaches later.
A vendor capable of providing the necessary documentation and support to maintain a validated state in a SaaS environment with better positon your organization and clinical trials for success. Bioclinica happens to be this kind of technology provider. If you'd like to learn more about us and our RBM services and ClearSite technology, drop me a line at Kristin.Mauri@bioclinica.com.