NEW YORK - Jan. 15, 2019 - Align Clinical CRO, a life sciences industry standards group that includes eight leading contract research organizations (CROs) and Veeva Systems (NYSE:VEEV), today announced its first technology standard is available for industry review and input. The new operational data exchange standard aims to facilitate seamless information sharing during clinical trials and give sponsors greater visibility into study execution when working with CROs.
Cross-functional domain experts developed the standard to improve the exchange of information between sponsors and CROs during phase II and phase III clinical trials. The standard supports operational data related to milestones and metrics for areas such as general trial information, study start-up, patient enrollment, and data management. The operational data exchange standard also provides technical considerations when developing APIs for clinical trial systems.
Align Clinical CRO is dedicated to creating open technology standards, with input from across the industry, that make it easier for sponsors and CROs to work together during trials. The group is now soliciting public review and feedback on its operational data exchange standard through March 15, 2019 at AlignClinicalCRO.org. Once industry input is received, Align Clinical CRO will make the final standard available in spring 2019.
As drug innovation has increased across the industry so has outsourcing to CROs as a way for sponsors to run trials faster and improve operational efficiency. By 2020, sponsors are expected to outsource 72% of clinical trials to CROs.[1] Pre-competitive industry standards can help bring more consistency to trial management and improve sponsor visibility into trial processes.
“Open technology standards can transform clinical trials to be more productive, reduce operational costs, and speed execution across the industry,” said Henry Levy, president of Align Clinical CRO. “Align Clinical CRO is committed to improving CRO collaboration with life sciences companies and reducing the time and effort in product development.”
To learn about the Align Clinical CRO mission and stay up-to-date on the standards in development, visit AlignClinicalCRO.org.
About Align Clinical CRO
Align Clinical CRO is an industry standards group founded by Veeva Systems and the world’s largest CROs. The group is dedicated to creating open technology standards that improve trial execution and collaboration with life sciences companies, making it easier for sponsors and CROs to work together during clinical trials. For more information, visit www.AlignClinicalCRO.org.
###
Contact:
Lisa Barbadora
Barbadora Ink
610-420-3413lbarbadora@barbadoraink.com
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.