tions. Beyond these, there are also various one-off tracking tools
used for things like study/site status, and monitoring schedules.
Nearly all respondents had at least one major challenge with
their clinical applications. The top two challenges—integrating
multiple applications and reporting across applications—are a
direct result of system silos.
Two years ago, Ora Clinical hired Leftin to modernize their
technology. He replaced aging, disconnected systems with unified, cloud-based technology, and has experienced a number
of benefits. “Now, everything is easy to see in one place. This
includes all of the regulatory and clinical documents, reports,
a dashboard showing performance, and key metrics such as
enrollment numbers. When you bring all of this technology
together, you are providing sponsors with total transparency,”
MANY SYSTEMS LEAD TO MANY CHALLENGES
Study start-up is a microcosm of the broader challenges companies face managing clinical trials, with multiple systems and
tools involved the start-up process. Veeva’s research shows that
the more tools a sponsor uses, the more challenges they report. A
separate study from Tufts Center for the Study of Drug Development had similar findings, with 95% of sponsors reporting challenges with study start-up.
Also consistent with Veeva’s research, Tufts found that the
time from the pre-study visit to contract execution accounts for
the majority of the lengthy study start-up cycle time. Almost two-thirds of sponsors in Veeva’s survey say contracting and budgeting are one of their most challenging study start-up processes.
Site identification selection and study planning during protocol
design were the next most oft-cited challenges.
Purpose-built study start-up applications are relatively nascent, with only a small percentage of sponsors leveraging this
technology. The vast majority still rely on spreadsheets to manage the complex study start-up process, reports Tufts Center,
with roughly one-third or less using CTMS, eTMF, or home-grown applications. Companies that use two or more tools to
manage study start-up practices report encountering at least
three challenges. With so many tools and systems, it is no surprise sponsors are frequently reporting issues in the crucial
study start-up process.
MODERN SYSTEMS ARE IMPROVING
The introduction of newer, more advanced applications and
platforms are helping sponsors and CROs start on the path
to streamlining the clinical ecosystem. Trial master file (TMF)
management solutions, for example, have experienced rapid
transformation over the past four years, with one in three
sponsor companies now using advanced eTMF applications,
more than doubling since 2014. And, 77% of sponsors using
modern e TMF applications report improvements in inspection
readiness and managing the growing volume and complexity
of clinical trials.
“We have significantly improved efficiencies across all of
THE RIPPLE EFFECT
clinical,” said Leftin. “This is particularly evident with our e TMF,
where everything is now done digitally in real time so there is
little clean up at the end. The days of searching for paperwork to
compile a paper TMF at study close-out are over.”
Similarly, there is also a shift underway with CTMS. A Markets
and Markets report forecasts life sciences organizations will in-
crease their CTMS investments by almost 15% each year through
2020 as sponsors report significant deficiencies in their current
systems. Ora Clinical, as one example, recently implemented a
cloud-based CTMS that’s part of a broader clinical suite applica-
tions.“The ability to bring together CTMS, e TMF, and study start-
up on a single, modern cloud platform is a real game-changer,”
said Leftin, “and will enable our organization to leverage the
same business processes and workflows throughout the lifecycle
of all our studies.”
Clinical trials are a critical part of the broader product development lifecycle, including regulatory, quality and manufacturing,
commercial, and medical. As the next big step forward, information will flow through to other parts of the organization and have
a positive impact across many areas.
Clinical and other functional groups need to access much of
the same information during different stages of drug development. Rather than using manual processes or complex integrations, cloud-based platforms enable different teams to access the
same information in multiple ways without redundant effort.
“After 25 years’ working in hospital systems where everything
is electronic and connected, I was excited to be a part of bringing these changes to the pharmaceutical industry,” said Leftin.“At
Ora, we have shifted away from paper in less than two years, and
are working to unify our systems across clinical and regulatory.
We have gained major efficiencies and streamlined workflows so
everyone is rowing in the same direction with the greatest benefit
of increased quality.”
There is great opportunity for both sponsors and CROs to
transform their operations by streamlining their clinical environments. Doing so will help address the growing complexity of trials, support end-to-end trial processes, and drive new levels of
efficiency and effectiveness across the entire clinical ecosystem.
Further, streamlining processes and being able to leverage information throughout the development lifecycle has even greater
potential expanded across organizations.
The Veeva 2017 Unified Clinical Operations Survey looked at
the drivers, barriers, and benefits of a unified clinical operating
model and tracked the move to streamline clinical systems and
processes. For the full report, visit: http://go.veeva.com/2017-unified-
JIM REILLY is vice president of Clinical Market Strategy at Veeva
Systems, where he is responsible for defining the market approach for the Vault Clinical suite of products. For the last 15
years, Reilly has held a variety of senior positions in life sciences
technology, where he has led software delivery and sales efforts in regulatory, clinical data standards, and content management. Reilly
holds an MBA in Information Systems from Villanova University and a B.S. in
Neuroscience from the University of Scranton. He can be reached at james.