January 3, 2018 | December was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Clinerion, Greenphire, Novaseek, and more.

HealthCarePoint (HCP) announced its mutual collaboration with Clinerion. The collaboration will further both companies’ shared mission of transforming clinical trials by expanding access to patient data analytics services. Members of the BlueCloud Sponsor Network will be able to view the locations and numbers of Clinerion’s patients on a dynamic map. Drill-downs allow the user to narrow the selection by therapeutic area and indication. Clinerion is expanding its global coverage rapidly and will keep the patient map up-to-date. With 76 Sponsors currently in their network, managerial healthcare professionals will now be able to search tens of millions of patients around the world on Clinerion’s PRS platform by therapeutic area and indication. The PRS solution queries hospital electronic patient health records to offer patient search and identification for clinical trials, as well as report generation for real-world evidence and market access analyses. PRS utilizes Clinerion’s proprietary “Anonymized Identification” technology, which ensures patient privacy by performing patient search and identification from fully anonymized records. Press release

Greenphire announced that Peachtree Bioresearch Solutions has selected eClinicalGPS to improve the accuracy, frequency and visibility of its investigator payment strategy. Peachtree Bioresearch Solutions is a full-service clinical research organization (CRO) that provides global clinical development services for emerging to mid-sized biotechnology, pharmaceutical, and medical device companies. “The site relationship is no different than any other business partnership. Ensuring our investigators are paid in a timely fashion with full transparency is critical to performance and fostering a close, trusting relationship,” said Kristy Nichols, President, CEO and Co-Founder of Peachtree, in a press release. “Partnership and performance are at the heart of our clinical development services. A top-quality site payment process ensures we continue to provide our clients with efficient and cost-effective services.” Press release

Greenphire also today launched a podcast series, Clinical Finance Optimized (CFO). Hosted by Greenphire’s Chief Financial Officer, Sue Vestri, the podcast will focus on financial management in clinical research, being responsive to clinical operations teams and the impact the finance team has on trial timelines and performance. “Strong, trusting business partnerships with vendors and sites is critical to the success of clinical research,” said Sue Vestri, in a press release. “My goal for this podcast is to help finance teams appreciate the impact they have on both the trial and business performance, as well as provide innovative and creative strategies for financial predictability and resource optimization.” Press release

In concert with its Brazilian partner, the iHealth Group, Clinerion has agreed with Bioserv to add Bioserv’s trial sites to the PRS platform. The Hospital São Vicente de Paulo is the first implementation, bringing another 540 thousand patient lives to Clinerion’s coverage in Brazil. Bioserv SMO manages trial sites in the Rio Grande do Sul region of Brazil. The first implementation of PRS will take place at the Hospital São Vicente de Paulo, in the city of Passo Fundo. São Vicente de Paulo has 600 beds, and its hospital information system holds 540K patient lives. The hospital’s 26 Principal Investigators specialize in multiple therapeutic areas, running studies in Phase Ib, II, III and IV on drugs and medical devices. Currently, they have 60 ongoing studies. Press release

Project Data Sphere has achieved two critical objectives in its mission to advance cancer care innovation and improve lives: data is now available from more than 133 research studies and represents over 100,000 patient lives. Scientists can benefit from a single place to investigate cancer trials that span multiple sources – dramatically simplifying and accelerating the research process. With over 40% of patient lives captured in the platform now representing experimental arm data, the scientific value of the Project Data Sphere platform has dramatically increased since the platform’s capabilities were extended beyond supporting just comparator treatment study data in April 2017. Press release

Interface People -- iPeople -- and Novaseek announced a partnership to enable easier integration of Novaseek's Clinical Data Network for Research (CDNR) platform into hospital/clinical IT systems. Through this collaboration, Novaseek's hospital and lab partners will gain access to on-site installation consultants who will install the CDNR platform without disruption of normal workflow. Press release

Immunovia announced that Sahlgrenska University Hospital is the first Swedish site to be part of PanFAM-1, a multicenter prospective validation study for the early diagnosis in familiar pancreatic cancer (FPC) high risk individuals. Designed to validate Immunovia ́s blood test, IMMray PanCan-d, the study which started one year ago at Ramon y Cajal Institute for Health Research (IRYCIS) in Madrid, Spain, will analyze thousands of individuals for three years across sites in both the US and Europe offering FPC screening programs, and will open up the market and sales for testing hereditary pancreatic cancer patients. “For 7 years, we have been conducting a surveillance program for familiar pancreatic cancer high risk individuals in our center,” says Svein Olav Bratlie, Head of the section for Pancreatic Surgery, at Sahlgrenska University Hospital, in a press release.  “It is obvious that early detection can lead to successful surgical intervention and consequently to better patient management. For this reason, an accurate, reliable and highly sensitive blood based test would be necessary. We are delighted to begin the prospective validation of IMMray PanCan-d in Sweden as part of our surveillance program of familiar pancreatic cancer high risk individuals and we are looking forward to the results.” Press release

Nanobiotix announced the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) Application for NBTXR3, a first-in-class nanoparticle designed for direct injection into cancerous tumors, activated by stereotactic ablative radiotherapy (SABR) and administered in combination with an anti-PD1 antibody (nivolumab or pembrolizumab). Laurent Levy, CEO of Nanobiotix, stated: “The FDA’s approval of Nanobiotix’s IND application for this trial is a major milestone for our Company. We’re ready and excited to launch our first immuno-oncology clinical trial in the U.S. combining NBTXR3 with a checkpoint inhibitor. Advancing our demonstration of NBTXR3’s potential to turn checkpoint inhibitor non-responders into responders could be game-changing, and the approach could address the unmet medical needs of a significant number of patients. Based on existing pre-clinical and clinical data, NBTXR3 could become a backbone in immuno-oncology.” The IND approval enables Nanobiotix to initiate NBTXR3-1100, a Phase I/II prospective, multi-center, open-label, and non-randomized clinical trial evaluating the efficacy and safety of NBTXR3 activated by SABR combined with checkpoint inhibitors (nivolumab or pembrolizumab). NBTXR3-1100 includes three cohorts of patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC), or with metastatic non-small cell lung cancer (NSCLC). The study will be conducted in two consecutive phases. The first of these will be dose escalation, followed by a dose expansion phase. The study will seek to enroll between 36 to 72 patients in Phase I and 40 patients in Phase II. Press release