The Current State of IT in Life Sciences Organizations
Authored by Rosemarie Truman, stock covered by Ken Nagy, CFA
Many Life Sciences organizations perform clinical development both internally with their own teams and also by leveraging Clinical Research Organizations (:CRO) providers. Depending on the size of the Life Sciences company, this means that they may have one or more of the following systems: Clinical Trial Management Systems (:CTMS), Clinical Data Management Systems (:CDMS), Electronic Data Capture (EDC), e-Diary Patient Reported Outcome (ePRO), Interactive Voice and Web Response System (IVRS/IWRS), randomization and trial supply management (:RTSM), Drug Supply Management System (:DSMS), Safety Database/System, project portals to share information and, finally, reporting systems. In addition, new smart phone apps have been integrated into the already complicated web of systems. While these are the core systems, it’s also critical to have these systems integrate with the Regulatory Submission, Lab Information Management, Image Management and several other applications/data sources.
Many of the current systems are “point solutions” and only handle one of the functions outlined above. It is nearly impossible to find a software provider that has thought through all the various integration points for all these system and offers a complete solution.
To add to the complexity of having a variety of point solutions that may or may not integrate, many times Life Sciences companies will have several sets of Clinical Application Architectures (:CAA) to deal with given varied relationships with CROs. For example, a common scenario is that Life Sciences companies will hire a CRO that does not have the same preferred platforms they have internally. Now, further imagine that the first CRO doesn’t work out, and then the Life Sciences company selects another CRO that doesn’t have the same clinical platform. The data for one product in clinical trials is now in three systems.
The typical situation is actually much more complicated than outlined above as not only are there multiple platforms of each type within the company; there are more than just two CROs.
To add to all this complexity, the FDA, more and more, wants to see nearly ALL the data in a harmonized form, especially for an NME NDA. If the number of clinical trials to submit NDA has doubled since 1980 (up to 68 trials to get one NME to market), we’re now talking about a lot of data integration; harmonization and complexity. What would happen if there are 6 CROs with different CAAs and at least 2 CAAs at the client site; those are 8 distinct data sets to harmonize, integrate and from which to create results.
Future State Requirements
Given the dynamics at play, the most desirable eClinical platform will go way beyond the typical requirements of stability; ease of use; high security able to support complex backup and recovery scenarios; etc. These requirements are table stakes. The desired future state platform should meet the following requirements:
• Comprehensive: Internally integrated, comprehensive suite of systems, including all the types above, e.g., CTMS, CDMS, EDC, IVRS/IWRS, etc.
• Integration Ready/Interoperable: Creating a platform for data Extraction and Transformation (:ETL) as well as for Clinical Application Integration (:CAI); this includes but is not limited to:
o Well-defined application programming interfaces (APIs) that allow outside developers to extend the system capabilities
o Pre-defined integration points for:
• third-party eClinical products
• term dictionaries/thesauri (i.e. MedDRA and WHOdrug)
• electronic medical records
• laboratory, or test equipment (Xray, MRI, EKG, etc.) systems
o Allows data to be imported/exported to/from the system
• Regulatory Compliance:
o System validation
o Electronic signatures
o Audit trails
• Delivery: Support fully hosted, partially hosted, SaaS, on-site possibilities. Hosted delivery can provide dedicated resources for a single client
o Integrated, interactive reporting spanning multiple products
o Able to offer many kinds of reports: ad-hoc, standard/”canned”, scheduled or multi-dimensional, including Key Performance Indicator dash-boards
o Capable of graphical output (i.e. charts and graphs)
• Full Featured Clinical Trial Support (“Extensible”): Can support Adaptive; Streamlined Adaptive; as well as other creative clinical trial designs
• Standardized: Support the CDISC/CDASH standardization initiatives
As mentioned previously, there has been practically no software provider that has thought through the required future-state CAA. In a resent objective assessment of all the major CAA software players, RHT Consulting found that DATATRAK (DATA) is truly the most visionary with regards to thinking through the “big picture” CAA requirements and also delivering the requirements. In particular, DATATRAK has conquered the integrated architecture with the use of a unified databae and has thought through the future state regulatory environment. RHT Consulting strongly recommends DATATRAK should be reviewed by anyone looking at their CAA strategy.
We see several differentiators as it relates to the nature of the product in that it’s not just software, it’s a platform. The platform allows for one integrated CAA solution. In addition, these “differentiators” have an amazing value proposition that can be quantified by an organization.
DATATRAK is a strong contender in the CAA space, offering a compelling reason to buy given above differentiators. To become a dominant player, DATATRAK needs to continue to capitalize on the very savvy starting point that they have to capture market share. Given the market dynamics are rapidly changing in this space, the window to capture this share and continue to innovate is probably closing in the next two years.
In past business cases RHT Consulting has developed, we have found the platform approach with a single source of truth can save 30 percent when considering the total cost of ownership. Our view is that an organization should develop a sophisticated business case based on all the factors to illustrate the value proposition that DATATRAK can potentially provide.
i Paddison, C., et al. Outsourcing Beyond the Comfort Zone. Pharmaceutical Technology Outsourcing
Resources 2005,p. 24. Available at http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=174014.
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