CTMS Solutions That Help Solve Clinical Trial Sponsor Challenges
Posted on Thu, Aug 26, 2010 @ 12:40 PM
Is Anything Really New in Clinical Trial Management System Platforms?
Robert Webber, Vice President, Clinical Trial Management Systems
Today’s clinical trial environment is very much open, involving multiple CROs and software from numerous vendors. Are the software solutions today keeping up with this increasingly complex environment? What are the challenges faced by today’s model? And what will tomorrow’s clinical trial management system (CTMS) platform look like?
The State of Today’s CTMS Platform
When we look carefully at today’s CMTS platform, there are five areas that seem to stand out. Those are clinical trial reporting, the user experience, working with business partners, business agility and managing software costs.
The state of today’s clinical trial environment poses many substantial challenges for a sponsor. Some of the biggest challenges that I’ve witnessed include:
- How can I report on data distributed across all these different clinical trial management systems?
- How can my clinical operations people deal with the complex user interfaces of numerous clinical applications they have to use?
- How can I effectively use CROs without losing oversight and control of my studies?
- How do I implement an IT infrastructure that provides the adaptability to meet my unique and evolving business needs?
- How do I manage my IT costs, especially if I have to integrate all these different systems for each study?
The challenges faced today by clinical trial sponsors demand a new approach to clinical trial software infrastructure – a broader vision than the conventional clinical trial suite.
The Next Generation of CTMS Offerings
Open Architecture with a Technology Platform. In this new approach, clinical data is made available in a normalized form to IT organizations and technology partners to customize and develop with the latest software tools – a new level of agility to meet changing business requirements.
Separation of Clinical and Operational Data. Web services alone do not enable open architecture. A next generation platform must provide an operational data model based on a core set of data definitions.
Collaboration. Collaboration means more than accessing the same data. It requires the translation of that data into targeted information based on user roles, configuring workflow.
Not Just Integration. Interoperability. Integrated systems share data. Interoperable systems allow users to perform similar functions from within their own applications. The next generation Clinical Trial Management Platform should address how users work within the most prevalent software user environment – Microsoft Office.
Microsoft SharePoint has changed the way clinical trial sponsors operate, providing each of the four CTMS offerings a common denominator from which to co-exist. BioClinica has found a way to leverage data with SharePoint Lists. This is a new and unique approach that will help clinical trial sponsors find CTMS solutions to the five challenges listed above.
Have you used the SharePoint platform in clinical trials? What other trial challenges are you seeing currently that this type of platform could assist? I welcome your thoughts and questions.
Download a copy of my white paper, The Next Generation Clinical Trial Management Platform, here.