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DONNA SMITH INTERVIEW
BIOGEN Clinical Project Manager
Q : Describe the evaluation process
for selecting a CTM.
A : Biogen hired a consulting company to drive the
assessment and evaluation process. The consultants assembled
a cross functional selection team which in turn created
a detailed list of specifications based on business
processes and business needs. CTM vendors were identified;
Requests for Information were generated; and responses
were evaluated. Three vendors were invited to submit
Requests for Proposals and to demo their products. The
selection team used a three point rating scale to access
software and vendor characteristics against the pre-identified
characteristics. A follow up demo and question and answer
session was scheduled with the prospective vendor to
confirm the assessment.
Q : What were the reasons for
your selection?
A : Oriam's TrialManager met the greatest number of
pre-defined requirements in the most satisfactory manner.
It was judged as the most visit centric, user-friendly
of those CTM systems evaluated. Requirements that were
not met - fully or partially - were assessed. Those,
which were critical to our business processes, were
met by development of either customized interfaces,
use of the Checklist feature in TrialManager, or expectation
of increased functionality in a future version up-grade.
Q : How did the vendor help to
implement EC-1 TrialManager?
A : Oriam hand-delivered all software and assisted
with installation. Oriam also customized, to the extent
possible, the installation for a Unix environment. They
provided assistance in applying our business processes
to the best use of the software. Overall, Oriam has
been very responsive to Biogen's requests. They have
incorporated reasonable requests into the current version;
and have made plans to include additional requests in
future upgrades.
Q : Have you saved time and money
in using EC-1 TrialManager?
A : It is too early in our implementation to have realized
a return on our investment in either time or money.
However, if we were to look at one particular business
process; investigator payments, it is clear that the
process is much more streamlined and accurate than the
manual process we had been using. Using TrialManager,
a visit ( or visits) is marked as performed and therefore
is "Payable". The contract specialist reviews
the completed visits and if a milestone has been reached,
generates an electronic check request using the Fee
Option. When the interface runs between TrialManager
and Oracle Financials, these visits are picked up, a
check is generated with the visit information printed
on the remittance stub, and the visit is marked Paid.
Q : Would you recommend EC-1
TrialManager and Oriam to another bio-pharma company?
A : Yes, we have been pleased with : the support Oriam
has provided during the implementation phase; the incorporation
of suggestions for future version upgrades; and the
overall direction Oriam is taking the product.
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