June 27, 2018 | June was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from eClinical Solutions, Veeva, Deloitte, and more.

eClinical Solutions announced that elluminate Data Central is available for use by elluminate platform and analytics customers. Designed by clinical data experts, elluminate Data Central enables data managers, medical data reviewers and study managers to improve the management and review of clinical trial data.  It replaces the time consuming manual steps currently required to assemble, aggregate, and track changes across numerous disparate data sources using tedious data listings, spreadsheets and systems with one centralized system for data review. With Data Central, clinical and operational data from systems including Electronic Data Capture (EDC), electronic patient reported outcomes (ePRO), Patient engagement applications, Labs and integrated voice response systems (IVRS) are available for users to review via intelligent reports and visual analytics. Role based permissions and issue management allow users to manage data by identifying discrepancies and outliers and to assign and track issues to users all within an auditable, regulatory compliant environment. “As an organization, we are constantly looking for ways to improve productivity and enhance data quality for all our customers, including our professional services teams which utilize elluminate on each engagement,” Raj Indupuri, eClinical Solutions CEO and Co-Founder, said in a press release. “The market feedback about elluminate Data Central has been extremely positive as it solves an unmet need and rapidly delivers value to users.” Press Release

Veeva announced Veeva Vault Training, a new cloud application to simplify role-based training across life sciences organizations and help quality teams remain audit-ready and compliant. Together with Veeva Vault QMS and Veeva Vault QualityDocs, Veeva will deliver a unified suite of quality applications on a single cloud platform that brings together training with quality processes and document control for seamless, end-to-end quality management. Quality teams are limited by manual training processes and fragmented systems that make it difficult to manage and track training and connect it to document change control or quality events. Vault Training will enable life sciences companies to easily and efficiently organize, assign, and track content and information so the right people are trained on policies and procedures. A centralized view of training across the organization provides full visibility into what content exists and who has achieved qualification to ensure job-readiness. Because Vault Training is part of the Veeva Vault Quality Suite of unified applications, individuals can seamlessly access critical content managed in Vault QualityDocs to efficiently complete training tasks. Also, quality events within Vault QMS automatically trigger training tasks for complete traceability and transparency of new training requirements. This enables organizations to stay current on role-based qualifications as events happen and policies change and have greater control over training content, from creation and approval to trainee completion. Press Release  

Deloitte , a 2018 Bio-IT World Best Practices Award-winner, has integrated its ConvergeHEALTH Patient Connect product with Apple HealthKit, CareKit, and ResearchKit frameworks, enabling patients to improve adherence to treatment plans while supporting connectivity to clinical research. This is the latest in a series of innovative additions to the ConvergeHEALTH product portfolio. ConvergeHEALTH is a group of products engineered and built by Deloitte to enable life sciences clients to respond to the shift to value-based, personalized medicine. In addition, Deloitte is expanding its Apple practice, a dedicated team of health care app developers in the Deloitte Digital studios. "This dedicated team of UI, UX and iOS engineers will specialize in developing health care-specific digital apps to transform the patient experience," Mike Brinker, global Deloitte Digital leader and principal at Deloitte Consulting, said in a press release. Press Release

TrialScope announced that it has promoted Francine Lane to Vice President of Global Transparency, a newly created position designed to better support sponsors in their management of complex global disclosure requirements. More than 50% of clinical trials are conducted outside of the U.S. and there are currently nearly 40 trial registries worldwide. Disclosure requirements are not consistent, making it difficult, costly and time consuming for sponsors to manage and stay compliant. In her new role, Lane will be responsible for helping customers meet and exceed current disclosure expectations globally, giving them the tools they need to meet all the requirements in this evolving industry. "We are starting to see increased pressure, both legal and ethical, to disclose results from regulatory bodies and activist groups," said Lane in a press release. "I am thrilled to take on this unique role, helping sponsors manage disclosure more efficiently in today's market and as new requirements emerge." Lane will also dedicate her time building relationships with external stakeholders, including sponsors, investigators, regulators, and transparency and patient advocates to help align the goals and expectations of these groups, as well as help identify more consistent ways sponsors can meet industry standards. Press Release

Certara announced the launch of Phoenix 8.1. Phoenix is a widely-used validated software for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) modeling and simulation worldwide. 90% of novel drugs approved by the US FDA are from companies that leverage Phoenix in their R&D programs. “Certara’s mission is to improve decision-making throughout the drug development continuum; we are involved at every step from selecting the best drug candidate to demonstrating its value to payers and health authorities. To that end, we are committed to providing a full range of modeling and simulation technology, advisory services, compliance support, and training programs to ensure that scientists optimize their work. We are proud to launch Phoenix 8.1, which offers significant statistical, graphical and validation enhancements to automate processes, saving both time and resources,” said Thomas Kerbusch, President of Certara Strategic Consulting, in a press release. Press Release

Syneos Health and Elligo Health Research are entering a strategic collaboration to mobilize a system of accelerated research to reach real-world patients. Both companies share a vision to evolve the clinical trial paradigm to speed the delivery of biopharmaceutical therapies to market. Syneos Health is a top three Contract Research Organization (CRO) that combines comprehensive and integrated outsourcing solutions for both clinical development and commercialization. Elligo Health Research deploys an approach that improves clinical trial access by engaging the 97% of physicians currently not offering clinical research to their patients. Applying its Goes Direct approach, Elligo identifies patients for clinical trials using electronic health records and then provides their physicians with the infrastructure to conduct the research in their own practices. This platform enables research at practices that historically would not have had the infrastructure to conduct clinical research. Syneos Health will collaborate with Elligo to pilot new ways of quickly finding patients to enlist them in clinical trial research. The collaboration will seek to build a centrally managed infrastructure and regulatory research system around physicians and patients who have not typically been accessible in traditional sites. This could include deploying expert staff and providing the training and regulatory guidance needed to run a trial, removing physician burden and focusing the experience around the patient. Press Release

NANOBIOTIX announced positive topline results of the Phase II/III act.in.sarc trial evaluating NBTXR3 in Soft Tissue Sarcoma (STS). "Data are exceptional and show without any doubt an improvement of radiation therapy impact with a significant number of complete response. NBTXR3 can bring real benefit to patients and it can change the standard of care. This innovation will play a role in many other indications and particularly where radiotherapy is used alone," Sylvie Bonvalot, Head of Sarcoma and Complex Tumor Surgery Unit at Institut Curie, Paris, France and Global Principal Investigator of the PII/III study, said in a press release. NBTXR3 is a first-in-class product with a new mode of action physically destroying cancer cells when activated by radiation therapy.  NBTXR3 is designed to directly destroy tumors and activate the immune system for both local control and systemic disease treatment. Press Release