October 31, 2017 | October was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Clinerion, Novaseek, goBalto, and more.

Clinerion expands the global coverage of its services in the Americas, adding 60 million patients in North America via partnership with Provisio. Clinerion now has a truly global footprint for its services for clinical trial patient search and identification, and data generation for real-world evidence and market access activities. Clinerion leverages the electronic health records of patients at its network of partner hospitals, hospital clusters, and hospital information system providers to provide patient data analytics services supporting clinical research, development, and marketing. In the past twelve months, Clinerion’s coverage has expanded across Europe, Asia, and South America. This partnership also brings Provisio’s Outreach Assistance service into Clinerion’s portfolio of patient recruitment capabilities for the USA. This service supports traditional outreach and enrollment efforts by providing data-driven intelligence on where pre-qualified patients are. Clients can optimize existing media and outreach programs by focusing on areas with high concentrations of pre-qualified patients and avoiding areas with few of them. With this partnership, hospitals, hospital clusters, and trials sites in the USA will gain exposure to the international clinical trials run by Clinerion’s clients. Trial managers for both academic and sponsored trials will benefit from a more efficient, single-point-of-access to patients on a global scale. Press release

Clinerion also announced that data integration to its Patient Recruitment System platform can now also process electronic medical records made available by hospitals using the Fast Healthcare Interoperability Resources (FHIR) standard. Hospitals using FHIR may now directly exchange data with Patient Recruitment System without the need for additional implementation effort. FHIR is a data exchange standard released by the Health Level Seven International (HL7) health-care standards organization for exchanging healthcare information electronically. FHIR is the latest connector technology which can be accommodated by Clinerion’s Patient Recruitment System. Clinerion’s highly flexible data integration system can handle different data models and standards. This covers i2b2 and more than ten other models used in different hospital information systems worldwide. In addition to FHIR, data exchange with Patient Recruitment System is also possible with the standards HL7, OMOP and RIM (the last two also released by HL7). Press release

goBalto announced its latest release of goBalto Activate. The third major release of 2017 offers new features that further accelerate clinical study startup. SSU is an array of activities performed at the outset of studies, including: investigative site selection and initiation, regulatory document submission, contract and budget negotiations, and enrolling the first subject. The process of initiating clinical trials remains unwieldy, challenging, and often behind schedule, making SSU one of the poorest performing aspects of clinical trials. At a time when SSU remains a perpetual bottleneck, leading companies are positioning themselves ahead of the curve by embracing solutions that confront these real challenges, thereby emphasizing differentiation and operational efficiencies. New APIs and functionality in the release allow for the exchange of alert or task information between Activate and the Shared Investigator Platform (SIP), and other industry site portals. Press release

Novaseek and hc1.com announced a partnership to help hospitals and clinical labs enhance their operations through improved performance and additional revenue streams. The collaboration enables hospitals and clinical labs to contribute to research by maximizing use of clinical information and lab specimens while reducing costs and growing lab revenue. Novaseek’s Clinical Data Network for Research (CDNR) platform is a cloud-based platform that transforms the way healthcare organizations and consented patients share biospecimens and clinical data with the research community.  The platform constantly scans for laboratory biospecimens that match researchers’ detailed clinical criteria, automating what was once a manual process of biospecimen selection and chart reviews. The CDNR makes it possible to fulfill complex requests, accelerating research and driving additional revenue for clinical labs as they assume a greater role supporting biomedical research. Press release

Almac Clinical Technologies has extended the functionality of its IXRS 3 IRT platform to include Accountability and Reconciliation Tracking (ART). ART captures all accountability data relating to the assignment, dispensation, and return of investigational medicinal products (IMP) throughout the course of a clinical trial. The toolkit provides total control over—and visibility into—the entire chain of custody down to the individual IMP unit level. This improves trial oversight, reduces dispensation errors, and strengthens patient safety. To conform to Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) sponsors must be able to prove that the IMP administered to patients was in a safe condition and that it was used only by subjects and according to the prescribed dose. All unused IMP must be accounted for at the end of the trial, and any discrepancies in records must be documented and explained. This process, when not supported by automation, is onerous and error-prone. ART is designed around a consistent and intuitive workflow across the full spectrum of the trial, providing insights on a single screen. Press release

Nanobiotix announced that it has completed patient inclusion for the Phase II/III trial of its lead product candidate, NBTXR3, in soft tissue sarcoma. The last patients are expected to start their treatment in two to three weeks. Elsa Borghi, Nanobiotix’s Chief Medical Officer commented: “We are pleased to have reached this important milestone in Nanobiotix’s soft tissue sarcoma study, and we look forward to reporting our first data next year.” The pivotal international Phase II/III study in soft tissue sarcoma was launched in Europe and Asia in October 2014 and aims to evaluate the safety and the efficacy of NBTXR3, a first-in-class radio-enhancer that could potentially target most solid tumors. The Phase II/III study is a prospective, randomized, multi-center, open label and active controlled two-arm study of 156 patients with locally advanced soft tissue sarcoma. The trial’s primary endpoint is the complete pathological response rate. The secondary endpoints are the objective response rate (ORR) by imaging (MRI); the evaluation of the safety profile in terms of clinical and laboratory adverse events; the tumor volume changes; the resection margins and the limb amputation rate. Furthermore, an exploratory analysis of the progression free survival is planned once the follow-up period has been completed for all treated patients. Press release

Cytel announced further expansion in Europe with the addition of an office in Basel, Switzerland. The new premises are scheduled to open by the end of 2017 and will join the company’s existing Geneva, Paris, Barcelona, and UK locations in Europe as part of a portfolio of 15 offices worldwide. During 2017, Cytel has added more than 150 biostatisticians, statistical programmers, and data managers in Europe and North America alone, and established new sites in King of Prussia, USA; Paris, France; and Ahmedabad, India. The company plans to hire up to 15 office-based members of staff in Basel by the end of 2018 as part of a wider global business growth strategy. Sébastien Gerin, Senior VP of Strategy and Performance at Cytel commented in a press release, “Switzerland is one of the leading centers for clinical development in the world. By establishing a new office in Basel, we will be able to cement our close collaborations with customers in the region and continue to build our team of statistical programmers, biostatisticians, and data managers.” Cytel’s Chief Human Resources Officer, Cary Morrill, commented, “At Cytel we are extremely proud of our excellent reputation as an employer. Therefore, we are confident that candidates will be as excited as we are about the opportunities at the new Basel site. We look forward to welcoming new team members on board over the next few months.” Press release

DCPrime and apceth report that they have entered into a strategic manufacturing agreement. The collaboration involves clinical batch production and the development of a commercial scale manufacturing process of cancer vaccines based on DCPrime’s technology platform DCOne. The companies also announce that apceth has recently successfully passed an inspection by the District Government of Upper Bavaria and the Paul-Ehrlich-Institute for the manufacturing license for production of DCP-001, DCPrime’s lead program. This will enable DCPrime to enter into a Phase II Proof of Concept study in Acute Myeloid Leukemia. Press release