February 28, 2018 | February was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from DrugDev, CRF Health, Bracket, and more.

CRF Health, a winner of the 2018 Clinical Informatics News Best Practices Awards, has announced the appointment of Bill Byrom as Vice President of Product Strategy & Innovation. Byrom, who brings more than two decades of pioneering industry experience to CRF Health, will help leverage the company’s growing solution portfolio including the Internet of Medical Things (IoMT). In his 27-year career, Byrom has served in leadership and advisory roles for notable global pharma influencers, including Knoll, Boots and Zeneca, and latterly with eClinical technology providers and service leaders, ClinPhone Group and Perceptive Informatics. He is renowned as a thought-leader and pioneer in strategy, development and operationalization of clinical trials technologies including mobile, wearable and electronic patient reported outcomes solutions. Most recently, he was Senior Director of Product Innovation with leading CRO ICON Clinical Research, responsible for driving direct-to-patient trial strategy and solution development. Press Release

Bracket announced the appointment of Michael P. Nolte as Chief Executive Officer. The company’s current CEO, Jeff Kinell, will remain on the Bracket Board of Directors as a strategic advisor. Mike Nolte is a seasoned industry leader who joins Bracket after serving as the Chief Executive Officer of Influence Health, where he led the strategy and delivery for the Consumer Experience Platform, supporting consumer-centric, digital healthcare. With a career spent at the intersection of healthcare, technology and service delivery, Nolte’s breadth of experience, strategic insight and proven track record align well with Bracket’s goals as it continues to invest in science-based, clinical development technology and service solutions. Press Release

Trial By Fire Solutions has expanded its SimpleTrials product, the first on-demand, subscription-based clinical trial management system (CTMS). Developed by clinical trial professionals with over 20 years of experience, SimpleTrials supports sponsors, sites and vendors. The CTMS allows users to manage calendars, milestones, documents, subjects and payments in a scalable feature set. The new electronic visit report (eVR) feature adds an easy-to-use report authoring and approval workflow tool for clinical monitoring teams. A template builder is available at the portfolio level for multi-study use. These features save time and provide study teams insight into site activities. Additional features include eVR attachments; integrated action items and subject deviations; alerts; and performance metrics and reports. Press Release

DrugDev announced Consent Engineering, the latest addition to the DrugDev Spark clinical operations suite, which provides all the proven benefits of standard eConsent with the added ability for sponsors and CROs to develop robust and scalable consent systems without having to rely on external providers. Consent Engineering on DrugDev Spark gives study teams the tools, training and best practice resources they need to create, manage and automate consent solutions in-house. This new ability significantly streamlines the time and cost of development and implementation, enabling sponsors and CROs to bring the proven benefits of eConsent to millions more patients worldwide. Features and benefits of the DrugDev solution include Centralized ICF authoring, review, and approval processes with uncompromising version control; intuitive structured form fields, progression checks, and wizard capabilities; guided ICF creation using templates, Word documents, prior ICFs, or built from scratch; unlimited trials, add/remove sites, manage access controls, and more; flexible deployment onto any tablet or device at sites, including those already in use (e.g. ePRO/eCOA); configurable role-based workflows (due dates, checklists, audit trails) and document attributes at the country and site level; robust API for facilitated integrations with IXRS, CTMS, EDC, eTMF; and ability to output paper consent and/or eConsent (with eSignature or print-to-sign) per individual study needs and country requirements. Press Release

eWellness (EWLL) announced that it plans to move its PHZIO platform to Blockchain in order to create higher security and better health data interoperability. Curtis Hollister, CTO for EWLL, stated in a press release, “Our PHZIO platform is already Tokenized, so the move to Blockchain is the obvious next step in the evolution of our PHZIO treatment platform. This Blockchain upgrade is anticipated to be completed no later than August 2018.  One of the benefits of this upgrade is it will provide us with the ability to provide insurance companies with a digital confirmation that a patient completed their PT sessions, thus reducing patient fraud.” Press Release

Citeline and Saama announced a partnership to integrate Citeline’s application programming interfaces (APIs) with Saama’s artificial intelligence and deep learning solutions. This is a strategic effort to bridge global clinical data and real-world data to improve both planning for and conducting clinical trials. Joint customers will get unparalleled insight into robust clinical trial intelligence with greater efficiency than before. Saama is integrating with Citeline’s APIs, including Trialtrove and Sitetrove, which provide users with the ability to go even deeper with search criteria and make better, more well-informed decisions, gain competitive advantage, and optimize ROI for their clinical trials. Combined with Saama’s real-world analytics, mutual customers will have smarter, more streamlined and successful clinical trials. Press Release

OTTR has partnered with Hemasoft. Interoperability between OTTR CompleteCellular and Hemasoft e-Delphyn help cellular transplant clinical teams enhance patient safety, streamline workflow, achieve seamless data exchange and improve cost efficiency. Unique lab processes, including connectivity with medical devices, integrate with hospital systems, optimizing patient care and saving time. Features include donor selection and donor eligibility determinations, cellular collection support, component manufacturing, quality processes, inventory management, distribution, and data organization and visualization. Press Release

Charles River Laboratories announced that it has entered into a definitive agreement to acquire MPI Research for approximately $800 million in cash, subject to customary closing adjustments. MPI is a premier non-clinical contract research organization (CRO) providing comprehensive testing services to biopharmaceutical and medical device companies worldwide. Acquiring MPI will enhance Charles River’s position as a leading global early-stage CRO by strengthening its ability to partner with clients across the drug discovery and development continuum. James C. Foster, Chairman and Chief Executive Officer of Charles River Laboratories, commented in a press release, “In addition to meeting our disciplined acquisition criteria, MPI is an exceptional strategic fit for Charles River because it incorporates the key attributes we require in an acquisition: access to growing end markets, high-quality services, scientific expertise, and complementary capabilities. MPI’S one-million-square-foot, single-site facility in Michigan will provide needed capacity to meet current and future demand.” Press Release

BullFrog AI and the Lieber Institute for Brain Development announced a joint collaboration to apply BullFrog AI’s proprietary artificial intelligence platform to analyze anti-psychotic drug responses. Under the terms of the agreement, BullFrog AI will utilize their proprietary artificial intelligence platform to analyze large multi-factorial clinical data sets from patients who received antipsychotic medication. BullFrog AI’s proven analytics engine (bfLEAP) will help physicians predict which patients respond best to which medications, effectively eliminating the problem of trial and error prescriptions. The bfLEAP analytics engine is uniquely suited to solving this type of problem. The platform is purpose-built for analyzing extremely large and complex data sets, something that is a known limitation for other analytical platforms. Indeed, bfLEAP has demonstrated 99.9% accuracy in predicting the right targets across multiple data sets. The key to its success is the artificial learning, which requires no domain expertise. Instead, it uses unsupervised machine learning coupled with the world's largest collection of analytical models, all operating in parallel. Press Release

Pharmaceutical Product Development (PPD) and Acurian announced a new patient concierge service designed to make it easier for patients and their caregivers to participate in clinical trials and to help pharmaceutical and biotechnology clients retain patients. “We’re introducing this innovative concierge service to help patients navigate the complexity of clinical trials, while providing support designed to enable them to better understand trials and the trial process, participation logistics and technologies,” said Niklas Morton, senior vice president of site and patient access for PPD, in a press release. “Our patient-centric service focuses on providing proactive trial guidance and an improved patient experience for individuals seeking life-changing treatments. This new service directly places the patient at the forefront of how we approach a trial.” The patient concierge service, initiated by PPD’s Rare Disease and Pediatric Center of Excellence, can be utilized in a wide variety of studies across all phases, therapeutic areas and indications. The company plans to introduce other concierge services and capabilities to investigative sites and PPD Laboratories later in 2018. Press Release