The first quarter of 2018 has witnessed plenty of action in, and insights about, the world of contract research organizations (CROs) providing study-related services to sponsors of drug and device research programs.
In late March, word came that a new industry technology standards group had been formed under the guise of Align Clinical CRO. According to a press release about the group, it “represents a first-ever global effort where CROs are joining forces to develop open technology standards to transform clinical trial operations.” The organization, which launched on March 27, brings together Veeva Systems and six leading CROs—ICON plc, Medpace, Pharmaceutical Product Development LLC (PPD), PRA Health Sciences, Syneos Health, and UBC.
“Within our organization, we’ve purposefully removed the silos between the clinical and commercial disciplines to provide solutions that improve operational delivery and enable our customers to speed therapies to patients,” says Rachel Stahler, Chief Information Officer for Syneos Health. “We’re thrilled to bring this spirit of collaboration to Align Clinical CRO, where we’ll work in partnership with our industry peers to transform clinical trial execution.”
Earlier the same month, Veeva Systems announced that Ora, Inc., a leading ophthalmic CRO, had adopted a suite of its products intended to unify clinical systems and processes. Ora is bringing together its clinical trial management system (CTMS), electronic trial master file, and study start-up applications on one platform to improve operational efficiency and visibility throughout its clinical trials.
How Integrating Your EMR and CTMS Can Become Reality – Get the tools you need to reap the benefits of an electronic medical records (EMR) / clinical trial management system (CTMS) integration by attending ACRP 2018 this April. Speakers representing Cerner PowerTrials, IBM CTMS for Sites, and a research site will break down the value of components of EMR/CTMS integrations and discuss how these interfaces can be implemented. Leave with a strong understanding of the considerations and configurations that need to be made for a successful EMR/CTMS integration. View Session Details
Speaking of CTMSs, which can be crucial to the ability of sponsors and CROs to manage large trials, a new report from Grand View Research Inc. estimates the global CTMS market will reach $2.26 billion by 2024. A press release about the report notes that “[r]ising research activities and increasing complexity in data management for multiple verticals such as pharmaceutical and biotechnology are anticipated to present the clinical trial management system market with lucrative opportunities over the forecast period.”
Further, a study on “Assessing Study Start-Up Practices, Performance, and Perceptions Among Sponsors and Contract Research Organizations,” released by the Tufts Center for the Study of Drug Development in January, surveyed more than 400 sponsors and CROs. It found in comparisons between sponsors and CROs that CROs completed all site-related start-up activities six to 11 weeks faster than sponsors.
“CROs, our study found, had faster start-up times than pharma or biotech companies because of their investment in technology, such as [CTMSs] and commercially available databases and market intelligence on investigators and sites,” wrote Mary Jo Lamberti, a senior research fellow at Tufts, about the results in STAT in late March. “As sponsors rely more on CROs to conduct clinical trials and manage site activity, CROs are continually looking to implement efficiencies.”
Edited by Gary Cramer