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
• etc.
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
• Reporting:
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
The Solution
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.
DATATRAK Differentiators
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.
Conclusions
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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