Faster time to finalize protocol design and upfront planning to
manage data outside the eCRF are keys to more efficient trials
New study also highlights need to transform clinical data management
practices to enable risk-based approaches
BOSTON & PLEASANTON, Calif.--(BUSINESS WIRE)--
At the upcoming DIA 2018 Annual Meeting, Tufts
Center for the Study of Drug Development (CSDD) will preview its
study findings on the root causes for delays and inefficiencies
impacting trial timelines. As a follow-up to the 2017
eClinical Landscape Study, sponsored by Veeva
Systems (NYSE:VEEV), Tufts CSDD spoke with more than 40 data
management executives about the top challenges and opportunities in
clinical data management. Findings indicate there is a significant
opportunity to transform data management practices for greater agility
and to accelerate adoption of risk-based approaches.
Protocol changes, amendments, and uncertainty in finalizing the protocol
design cause upfront delays that have a negative downstream impact on
key data management activities. Clinical leaders indicate that improving
processes for early consensus and leveraging modern, agile systems that
better adapt to protocol changes can significantly streamline execution
and speed timelines.
Executives also expressed concerns with the ability to manage data
beyond eCRF. They believe having a steady stream of comprehensive and
clean data throughout the trial, much of it prioritized through
risk-based approaches, will assist in faster decision-making and shorter
overall cycle times.
“Protocol design is taking longer to finalize and undergoing more
iterations, creating challenges in data management and overall trial
efficiency,” said Ken Getz, research associate professor and director at
the Tufts Center for the Study of Drug Development. “Also, data volume
supporting clinical endpoints is rapidly increasing. More data comes
from sources other than eCRF and lab data, creating substantial
integration and coordination difficulties for data management.”
“There is tremendous opportunity to address the limitations of
traditional data collection to accelerate clinical trial timelines,”
said Henry Levy, chief strategy officer at Veeva. “As the number of data
sources continues to rise, data management teams will have a greater
need to see all their clinical data, at all times. Veeva’s vision is to
help organizations seamlessly bring their data together throughout the
course of a trial and make the transition to risk-based trials where
data is collected and analyzed for a current, holistic view of the
patient.”
Join Veeva and Tufts CSDD at the DIA 2018 Annual Meeting for more
details on the study results and their implications. Don’t miss their
session on Tuesday, June 26, at 1:10 p.m. in theater #2 of the exhibit
hall. Richard Young, vice president of Veeva Vault EDC, will also share
Veeva’s vision for the future of clinical data management. Learn more at veeva.com/DIA2018.
Additional Information
Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems
Follow @veevasystems on Twitter: twitter.com/veevasystems
Like Veeva on Facebook: facebook.com/veevasystems
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development at Tufts University
provides strategic information to help drug developers, regulators, and
policy makers improve the quality and efficiency of pharmaceutical
development, review, and utilization. Tufts CSDD, based in Boston,
conducts a wide range of in-depth analyses on pharmaceutical issues and
hosts symposia, workshops, and public forums, and publishes Tufts CSDD
Impact Reports, a bi-monthly newsletter providing analysis and insight
into critical drug development issues. For more information, visit csdd.tufts.edu.
About Veeva Systems
Veeva Systems Inc. is a leader in cloud-based software for the global
life sciences industry. Committed to innovation, product excellence, and
customer success, Veeva has more than 625 customers, ranging from the
world's largest pharmaceutical companies to emerging biotechs. Veeva is
headquartered in the San Francisco Bay Area, with offices in Europe,
Asia, and Latin America. For more information, visit veeva.com.
Forward-looking Statements
This release contains forward-looking statements, including the market
demand for and acceptance of Veeva’s products and services, the results
from use of Veeva’s products and services, and general business
conditions, particularly in the life sciences industry. Any
forward-looking statements contained in this press release are based
upon Veeva’s historical performance and its current plans, estimates,
and expectations, and are not a representation that such plans,
estimates, or expectations will be achieved. These forward-looking
statements represent Veeva’s expectations as of the date of this press
announcement. Subsequent events may cause these expectations to change,
and Veeva disclaims any obligation to update the forward-looking
statements in the future. These forward-looking statements are subject
to known and unknown risks and uncertainties that may cause actual
results to differ materially. Additional risks and uncertainties that
could affect Veeva’s financial results are included under the captions,
“Risk Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations,” in the company’s filing on Form
10-Q for the period ended April 30, 2018. This is available on the
company’s website at veeva.com
under the Investors section and on the SEC’s website at sec.gov.
Further information on potential risks that could affect actual results
will be included in other filings Veeva makes with the SEC from time to
time.
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Source: Veeva Systems Inc.