January 28, 2021 | Strategic collaborations to enable more diverse trial populations, advance combinatorial intravesical immunotherapy, and engage patients in a privacy-centric way. Plus: new partnership program for CROs and an Oracle integration for Cognizant’s Shared Investigator Platform.

Cognizant’s Shared Investigator Platform (SIP) is now integrated with Oracle Health Sciences. By standardizing administrative tasks and processes with one unified system, sponsors and CROs can reduce study startup time, increase collaboration, and streamline the management of clinical trials. A global leader in business and technology services, Cognizant is a member of Oracle PartnerNetwork (OPN). Cognizant and Oracle, both recognized industry leaders, have combined the SIP solution and study startup offerings to address these site challenges and deliver unique value in the initialization of studies, collaboration, and management. By combining the Oracle and Cognizant systems, CROs and sponsors will be able to ease common burdens, such as manual, paper processes, navigate disparate technology systems, and eliminate multiple log-ins. For sites, the integration provides a centralized site profile that is maintained by the site and can be leveraged across multiple studies by sponsors and CROs. This centralization, plus the ability to use a single log-in, will save both time and costs. Press release.

The Decentralized Trials & Research Alliance (DTRA) is an alliance of life sciences and healthcare organizations that seeks to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The DTRA launched in late 2020 to unite industry stakeholders, including healthcare companies, regulators, patient groups and research organizations, to make clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research. Several new groups have announced their joining: Firma Clinical, Withings, NurseNow, and QYNAPSE.

Calyx has announced a valuable new partnership program for Clinical Research Organizations (CROs). The program, “ACTIVATE Solutions for CRO Partners,” is designed to provide close alignment between Calyx and its CRO partners. By participating in the ACTIVATE program, CROs can meet the needs of their many different clients and help accelerate trial execution and data collection, ultimately delivering more customer value. CROs who qualify to participate in ACTIVATE operate under a personalized governance and reporting structure that drives real value to their customers. Access to industry-leading technology, accelerated decision-making, and streamlined issue resolution increase clinical trial efficiencies, improve study quality, and generate faster trial execution. Press release.

Reify Health has announced that StudyTeam is now available to clinical research sites in 100 countries worldwide. In the last year alone, Reify Health has expanded availability of StudyTeam to 88 new countries. This milestone marks Reify Health’s investment in providing sites with effective solutions to manage recruitment and enrollment and drastically reduce the manual work historically required from sites during trials. Currently, more than 2,700 global research sites use StudyTeam to manage patient recruitment and enrollment. Those sites are connected seamlessly and securely with numerous leading biopharma sponsors - including Amgen, AstraZeneca, and Eli Lilly and Company - so that critical information about recruitment activity can be shared in real time without sites needing to duplicate work they have already done. Press release.

The University of Texas MD Anderson Cancer Center and UroGen Pharma have announced a strategic three-year collaboration agreement to advance combinatorial intravesical immunotherapy, which is delivered directly into the bladder, for the treatment of high-grade non-muscle invasive bladder cancer (HG-NMIBC). UroGen's approach involves the local delivery of potent immunomodulators (UGN-201, a TLR 7/8 agonist and UGN-301, an anti-CTLA-4 antibody). UGN-301, an immune checkpoint inhibitor, is delivered using UroGen's proprietary RTGelTM platform to increase dwell time, which has been shown to significantly improve the effectiveness of intravesical therapy. Under the agreement, MD Anderson and UroGen will collaborate on the design and conduct of non-clinical and clinical studies with oversight from a joint steering committee. UroGen will provide funding, developmental candidates, and other support. Press release.

In an overwhelming majority vote, 99% of voting shareholders support the Veeva Systems’ proposal to become a public benefit corporation (PBC), including the vast majority of Veeva’s largest shareholders. Veeva will become a public benefit corporation on Feb. 1, 2021, making it the first publicly traded company and largest-ever to convert to a PBC. As a PBC, Veeva will remain a for-profit corporation but will be legally responsible to balance the interests of multiple stakeholders, including customers, employees, partners, and shareholders. It will also broaden its certificate of incorporation to include a public benefit purpose, ‘to help make the industries it serves more productive and create high-quality employment opportunities.’ Veeva’s proposal to declassify its board of directors also received near unanimous approval by shareholders today. Press release.

The American Society of Hematology (ASH), the International Society on Thrombosis and Haemostasis (ISTH), National Hemophilia Foundation (NHF), and World Federation of Hemophilia (WFH) have developed joint clinical practice guidelines on the diagnosis and management of von Willebrand Disease (VWD), the world's most common inherited bleeding disorder. The guidelines were published in Blood Advances. Guidelines.

Parexel and Signify Health have announced a strategic collaboration to provide customers with new solutions to enable access to a more diverse and traditionally underrepresented population for their clinical trials. The partnership will focus on improving patient access to clinical trials, bringing studies to patients in their own homes, and identifying relevant social determinants of health (SDoH) to facilitate connections among local resources, patients, and caregivers. Over the coming months, the companies will explore opportunities to address social determinants of health issues as part of the clinical trials recruitment and management processes with the intention of initiating their first pilot program during the first half of 2021. Press release.

Trialbee is partnering with LiveRamp to expand the pool of potential patients and then match and engage patients for clinical trials in a privacy-centric way. This partnership will help to avoid such inefficiencies inherent to untargeted patient recruitment. Trialbee will use LiveRamp’s data connectivity platform to scale a patient seed model for a specific trial protocol to reach a larger pool of matched patients who may be motivated to participate in a clinical trial. Trialbee will further engage with patients through the company’s unique triple qualification process, which includes online qualification and nurse panel interviews to ensure high-quality patient matches prior to study enrollment. Press release.