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 TigerLogic®
Clinical Trials Data Services
Product
Overview
Raining Data’s TigerLogic Clinical Trials
Data Services (CTDS) allows drug sponsors and large Contract
Research Organizations (CRO) to aggregate and transform their
legacy clinical data to the industry standard Clinical Data
Interchange Standards Consortium (CDSIC) Operational Data Model
(ODM) or Study Data Tabulation Model (SDTM) for data exchange
with 3rd party partners.
TigerLogic
CTDS accepts legacy clinical data in any format such as SAS,
Oracle and CSV (Comma Separated Values). This data is validated
based on business or regulatory rules (such as 21 CFR Part 11)
and transformed into the specified central repository standard.
This clinical data is then available to data consumers such
as other internal systems, partner systems and analytic tools
with group based secure views to enforce privacy policies. TigerLogic
CTDS is also used for audit purposes to identify who did what
and when.
Large sponsors
or CROs will be interested in TigerLogic CTDS to provide a single
view of their clinical trial data and associated research in
an industry standard format.
The
Innovative Technology
TigerLogic CTDS is built on the TigerLogic XML (eXtensible Markup
Language) Data Management Server (XDMS). The TigerLogic XDMS
is a native XML data management system that accepts clinical
data in any format and transforms it into the CDISC industry
standard, which is an XML document. TigerLogic XDMS comes with
extensive security and access rights to limit clinical trial
visibility. The flexibility of TigerLogic XDMS allows sponsors
and CROs to validate current clinical data across multiple legacy
data sources. Exhibit 1 illustrates legacy clinical data stored
in a relational database (RDBMS). Exhibit 2 illustrates the
clinical data transformed to the CDISC ODM standard.
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Exhibit
1: Clinical Data in an RDBMS |
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Exhibit
2: Final ODM Compliant Output |
The TigerLogic
XDMS system inspects new data to validate it, identifies changes
in data values or structures and triggers exception handling
processes. The power of the technology is the multi-schema engine,
which not only handles multiple schemas, but also evolves to
handle new schemas. For example, as CDISC ODM changes from V1.2.1
to V1.3, or as an Electronic Data Capture (EDC) evolves its
data schema, adds new data fields, the TigerLogic XDMS evolves
to handle these new structures as well as the original ones.
Additionally, TigerLogic XDMS can be configured to store data
value changes as sub-elements to current values. These sub-elements
could include the previous value, a time stamp of the change
and who changed it.
TigerLogic
CTDS can be deployed quickly in many technical environments.
TigerLogic CTDS comes with a powerful 3rd party Independent
Development Environment (IDE) to map data from legacy clinical
systems to the central repository and from the central repository
to the data consumers. For example, Legacy System 1 might have
a gender field with acceptable values of “M” or
“F”. This field and its values are quickly mapped
to the gender element in the repository with acceptable values
of male or female. Exhibit 3 illustrates the data mapping tool.
Problems
Addressed by TigerLogic CTDS
Most
drug sponsors and CROs are swimming in trial drug data, but
do not have the means to bring it all together in a usable form.
Real-time accurate visibility would allow drug sponsors to improve
patient safety, enable adaptive trials, improve CRO productivity
and better manage the overall drug portfolio. The key challenge
is that a typical drug study may have as many as 40 different
trials running and associated research data may be spread across
as many as 12 different back-end systems and data warehouses
over many years with diverse data definitions and schemas. The
source data structures are complex and dynamic. Fixed data mapping
from a target to a source will constantly be broken and impossible
to maintain. Additionally, clinical data quickly gets out of
sync with similar data in other systems (e.g., safety) leading
to sub-optimal decisions. TigerLogic CTDS acts as a clinical
trial data hub or Operational Data Store (ODS) and feeds other
systems or analytic tools.
Another
problem area is the current technical environment may not be
able to aggregate the data from the different legacy data sources
and transform it to CDISC standard for information exchange
with 3rd parties as well as vice-versa. The Extract Transform
Load (ETL) data warehouse process that brings together clinical
data for drug sponsors or CROs does not support dynamic data
sources where changes occur in unanticipated ways. Currently,
changing data structures (new or deleted fields) break the ETL
process and require a reactive response. TigerLogic CTDS does
not have this problem since it evolves with new data structures.
Additionally, Slowly Changing Dimensions Type 2 (SCD) is not
managed well with current technologies, which require artificial
records and table joins. As stated earlier, TigerLogic CTDS
can store data changes as sub-elements to current values and
maintain a single view of the data. This improves auditability
and analytics of the clinical data.
Finally,
conversion to or from the current version of CDISC ODM will
often be a challenge for most drug sponsors and CROs. TigerLogic
CTDS, with its multi-schema engine, easily manages the multiple
CDISC ODM versions and can apply transformation to any of the
stored clinical data. In fact, a new CDISC ODM can be loaded
into TigerLogic CTDS, where the system will evolve to the new
schema, and existing data can be re-purposed using this new
schema.
TigerLogic
CTDS Product Availability
TigerLogic CTDS is available now for customer Proof of Concept
(POC). The product supports Windows, Linux and Solaris.
Best
of Show Awards Finalist for the Bio-IT World Conference &
Expo
Raining Data's TigerLogic Clinical Trials Data Services was
chosen as a finalist in the Best of Show Awards among entries
submitted from leading Bio-IT vendors exhibiting at the
2007 Bio-IT
World Conference & Expo.
Product
Brochure
TigerLogic
Clinical Trials Data Services Product Overview (234 KB pdf)
Contact
Us
For inquiries, please contact TigerLogic Clinical Trials
Data Services at 949-442-4400 or email
tl-ctds@rainingdata.com.
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