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Clinical
Trial Management: TrialStat’s
ClinicalAnalytics 4.0
ClinicalAnalytics
(CA) is an integrated Web and handheld-based
Electronic Data Capture solution. It’s designed to
be simple enough that users can design, configure, and
manage their own clinical research projects through a
browser interface. Studies can be deployed in as
little as a week, and adding multiple sites or new
studies is meant to be simple and straightforward.
Clinicians can point data toward their Web browser,
their handheld device, or both—it is also possible
to enter patient data in real time, into a device that
does not have Internet access, for synchronization
later on when it is convenient for the clinician.
Selected Features
CA’s
image-based
data capture can save valuable time in the clinic.
For example, instead of writing out in long-hand the
anatomical locations of a rheumatoid arthritis
patient’s pain, a touch of the stylus on the
physician’s handheld device clearly indicates on a
virtual map the source(s) of discomfort. It is also
possible to differentiate the degree of discomfort at
each point, e.g. from mild discomfort to severe pain.
TrialStat
provides complete
data-management services from biostatistics,
data entry, adverse-event coding, and training to
project management.
Case in point: Time-pressed researchers can employ
TrialStat’s biostatisticians to run and analyze
their data for them. TrialStat reports that in their
third quarter, 50% of all clinical studies were
delivered with full data-management services.
CA
features browser-side
encryption. Highly
sensitive patient data, such as health card numbers or
other identifying information, is encrypted prior to
being sent from the user’s Web browser to
TrialStat’s hosted server. A user-managed electronic
security key is used to encrypt and decrypt specified
data fields. These data elements are completely
obscured, ensuring that only those who created the
data can access it in decrypted format. Clinicians are
urged to keep a copy of their security key in a
safe-deposit box or other secure location, as their
self-encrypted information never reaches TrialStat’s
hosted servers in a readable format.
Scheduled
for release in December 2006, version
4.0 of CA will have the following new features:
- Built in graphing
capabilities for added convenience. CA 4.0 includes Clinical Intell graphing functions,
which work similarly to programs such as Microsoft
Excel, eliminating the need to export data to an
external program. Data are displayed in standard
table format, as well as in a comprehensive
selection of charts and graph types.
- Post data-entry validation. CA currently delivers comprehensive data
validation at the point of capture, but CA 4.0’s
new enhancement permits the design and use of
complex validation rules that can be run against a
full data set at any time.
- Data dictionary
automation. Study
managers can upload and use any standard
dictionary in their projects. Coded form fields
enable quick lookups, allowing data-entry staff to
quickly select dictionary terms instead of having
to enter them by hand.
- Double data entry.
Improved
support for those studies capturing data on
paper—streamlines data entry and provides
conflict-detection interfaces.
Vendor: TrialStat Corporation
Product:
ClinicalAnalytics 4.0
Available:
December 2006
Price:
Based on flat rates according to number of users
For more
information: Visit www.trialstat.com
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