LIFESCIENCELEADER.COM JULY 2014
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evolution toward a single source of shared
electronic documents is helping stake-
holders modify processes that improve
collaboration and gain business insights.
"We recognized from the outset that
going electronic with our TMF would
be critical to improving efficiency and
enabling seamless collaboration with trial
stakeholders around the world. Now, in
order to maximize the system's value, we
are reengineering our SOPs to reflect the
advantages of a cloud-based eTMF and to
move forward with study success — ulti-
mately delivering much-needed drug ther-
apies to patients faster," concluded Fate.
L
als, what steps can be taken to shorten this
activity and improve cycle time?"
This is the point at which the eTMF
builds to a greater level of sophistication.
The eTMF can help with business deci-
sions by gathering an array of quality, per-
formance, and operational metrics that
are both internal and external and across
multiple sites and studies.
eTMF: AN ESSENTIAL TOOL
With increasing pressure to meet clinical
trial timelines and rein in costs, sponsors
and CROs are looking to the eTMF as an
essential tool for completing and collect-
ing the array of documents involved in
clinical trials — and for using the resulting
data to identify process improvements.
The urgent need for greater visibility into
study conduct and quality benchmarks
for trial operations is driving the indus-
try's growing use of new technology. This
into what's approved and what's missing.
These common, trial-specific perfor-
mance metrics — efficiency and complete-
ness — establish a baseline for improve-
ment, allowing managers to look at met-
rics in an organized way as opposed to
extrapolating from paper-based processes.
However, as more data is collected over time
and across multiple trials, it also becomes
possible to identify trends. "What about
improving cycle time? Time to database
lock? Are things getting better? Worse?
Which sites are the best performers? When
you start to ask those questions and get
answers, users are ready to move toward
a more mature phase in the process," says
Sullivan. "Eventually, the eTMF expands in
value when organizations can determine
whether problems are unique to one study
or if there is a common problem across
multiple trials. For example, if the contract-
ing process is too lengthy for numerous tri-
Jennifer Goldsmith is VP of Veeva Vault at Veeva Systems.
Lisa Mulcahy is owner and principal at Mulcahy
Consulting. She is an expert in the TMF f eld and eTMF
implementations.
REMOVES COMPLEXITIES
IN CLINICAL TRIALS
leading to Better Site Compliance, Better Data, and Ultimately a Safer Trial
datatrak.com +1.440.443.0082 marketing@datatrak.com
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