May 1, 2019 | April was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Mount Sinai, TrialAssure, Greenphire, and more.

DrFirst announced that it has structured a new $17 million commercial financing facility with SunTrust Banks. The financing extends DrFirst's strategic relationship with SunTrust Banks, a partnership which initially began in 2015. "We are truly thrilled about our continued relationship with DrFirst," said Greg Brouillette, senior vice president of the Maryland Commercial Banking Team at SunTrust Banks, in a press release. "We believe in the company and all it is doing as leaders in healthcare IT. Since we began working together in 2015, DrFirst has always been a great business that has continued to grow in terms of product set and market share. This transaction will strengthen our relationship further. As a top leading bank, we are proud of the long-term relationship we have with DrFirst and look forward to supporting its continued growth and positive impact on the market." The new funds will support the expansion of DrFirst's operational and development efforts for initiatives targeting the pharma and consumer sectors. Press release

Mount Sinai Health System has launched a clinical trial of a new imaging device for detecting head and neck cancer during surgery. The device, called Otis Wide Field OCT (by Perimeter Medical Imaging), is an ultra-high-resolution imaging system that can image tumor specimens in real time during surgery, allowing surgeons to remove all of the cancerous tissue during one procedure, rather than waiting for traditional pathology results to come in afterward, which can often lead to additional procedures. Patients in the trial agree to have their tumors placed in the system for imaging, which is then compared to the standard pathology evaluation. "State-of-the-art imaging platforms, such as the Otis system and others, will likely play a significant role in the future of head and neck cancer surgery. While traditional pathologic examination of tissues is the standard around the world, we need new technology to allow us to detect cancer and ensure adequate resection at the time of surgery," lead investigator Brett Miles, Associate Professor of Otolaryngology at the Icahn School of Medicine at Mount Sinai, and Co-Chief of the Division of Head and Neck Oncology for the Mount Sinai Health System, said in a press release. "Data from this study, and other projects in the optical imaging program, will help us understand how beneficial these technologies may be and drive future innovation during head and neck cancer surgery." Press release

TrialAssure announced the launch of TrialAssure REGISTRY 2.5, the latest iteration of TrialAssure's premiere clinical trial registration and disclosure reporting application with a configurable workflow engine that allows clients to augment regulatory intelligence for global registries. The three main new features in REGISTRY 2.5 include: an improved, more customizable Workflow Management Hub, enhanced alignment to global registry changes, and smarter alerts for delinquency findings – all designed to keep sponsors on track and meet sensitive deadlines. "From design to development, sponsor input has inspired TrialAssure REGISTRY 2.5," said Mohamad Zahreddine, CIO, TrialAssure and member of the Forbes Technology Council, in a press release. "We consistently seek sponsor feedback to improve all facets of our software. Since sponsors use the product daily, they have unique perspectives and suggestions for strengthening even the smallest functionality, and TrialAssure employs a flexible operating model with in-house developers that makes implementing changes quick and easy." Press release

Greenphire announced that it has released a new tax capability for its customers, easing the administrative burden of reporting, tracking, and managing tax associated with participant payments. The new capability enhances Greenphire's existing 1099 reporting capability, while offering further control over the payment and reimbursement process. Additionally, this enhancement, which has been reviewed and certified by an independent tax advisory, makes ClinCard the only clinical trial participant payment software to support tax compliance. Developed based on insights from sites and sponsors about their top payment challenges, the new tax offering aids in streamlining the tumultuous reconciliation process, replacing time and labor-intensive manual processes while enabling IRS tax compliance. Its automated functionality also reduces the risk of human error, saving sites from future financial and administrative headaches. Greenphire's new tax capability for ClinCard customers includes the following features and benefits: automatically determines taxability based on transaction type; automatically withholds a portion of taxable payments when Tax Identification Number (TIN) is unavailable / invalid; boosts efficiency with real-time, TIN validation, eliminating the need for site staff to manually validate TINs via a separate application; allows for configuation flexibility (i.e. withholding percent, thresholds, approach); provides comprehensive reporting functionality, including a Taxable Payments report for enhanced remittance transparency; and automates 1099-MISC production. Press release

Certara announced four senior executive appointments in its Simcyp division. Rob Aspbury, joins Simcyp as Chief Operating Officer; Frederic Yves Bois, is the division’s new Senior Scientific Advisor and Head of Mechanistic Modeling; Will Redfern, is Vice President, Quantitative Systems Toxicology and Safety; and Noriko Okudaira is Senior Consultant/Scientific Advisor supporting Certara’s clients locally in Japan. Aspbury brings more than 17 years’ commercial and scientific leadership experience with Covance to Certara. Aspbury was appointed Global Finance Director for Covance’s Clinical Pharmacology Services Division in 2003 and was rapidly promoted within the division to Managing Director, then Vice President, Europe, and later Vice President and General Manager, Global. His most recent appointment was Vice President of Covance Strategic Solutions, Biosimilars. Bois was Research Director of the French National Institute for Industrial Environment and Risks (INERIS) before joining Certara. For six years, he also served in parallel as Professor and Chair of Mathematical Modeling for Systems Toxicology at UTC and INERIS. Bois is a recognized expert in Bayesian calibration of complex differential equation-based models. He has also served as a public health policy and regulatory risk assessment consultant to the US FDA, EPA and OSHA, the European Commission, and the French Ministry of the Environment. Bois is author or co-author of more than 150 peer-reviewed articles and recipient of the American Statistical Association’s Outstanding Statistical Application Award, and the French Epidaure Prize for Environmental Health Research. Redfern is an international key opinion leader with more than 30 years’ experience in in vivo central nervous system and cardiovascular safety pharmacology. He joins Certara from AstraZeneca R&D in Cambridge (UK) where he was Principal Scientist for Safety and Mechanistic Pharmacology. Redfern is author or co-author of 36 peer-reviewed articles, six book chapters, 91 conference proceedings abstracts, and two drug patents. He is a past president of the Safety Pharmacology Society and has received both the organization’s Technological Innovation Award and its Distinguished Service Award. Okudaira comes to Certara from Daiichi Sankyo where she served as Director of the Clinical Pharmacology Department. Prior to that, she was Senior Researcher and later Senior Director of Daiichi Sankyo’s Drug Metabolism and Pharmacokinetic Research Laboratories. Press release

Zipnosis launched ZipPlus, a services and tech enablement program that creates a multi-year, integrated virtual care roadmap for health systems using Zipnosis' virtual care chassis while leveraging 10 years of virtual care leadership and experience. "We continue to hear from our health system customers that virtual care deployment is narrow and integration is a challenge, and in many cases prohibiting widespread adoption," said Jon Pearce, CEO, Zipnosis, in a press release. "ZipPlus breaks down these barriers in two ways. The first barrier is technology. Within the ZipPlus program, we can fully integrate the patient and provider experience via FHIR or API's into Epic, Cerner and Athena. The second barrier is an aligned strategy for virtualizing care. With ZipPlus, Zipnosis and our partners sit down to create a multi-year roadmap for clinical business lines, such as behavioral health, post-surgical follow-up, travel medicine, hypertension - or any service using our powerful virtual care technology platform as the foundation. These unique roadmap partnerships are truly a first for the industry and position us well as the undisputed standard in virtual care." Press releae

Scientist.com announced the launch of Trial Insights, a digital reporting solution that simplifies data produced through clinical trial, biomarker and medical diagnostic studies into an intuitive and user-friendly dashboard. The first of its kind, Trial Insights curates publicly available data nightly from information hubs such as clinicaltrials.gov and customizes it to fit a researcher or research organization's specific project needs. "Trial Insights offers researchers an easy way to navigate the complexity of clinical trials information," Ron Ranauro, Founder of Incite Advisors, said in a press release. "Since Trial Insights' content is digitally curated, researchers can continuously keep track of the evolving landscape of drugs, diseases, sponsors, investigators and medical devices important to their work." As the velocity, variety and veracity of data available on sites like clinicaltrials.gov continues to increase, the ability to curate it becomes more valuable to different audiences. With the advancement of personalized medicine, it is important to make the data accessible to the health care and patient communities. Information found on the Trial Insights platform can help guide decision making across the pharmaceutical, biotechnology and contract research organization industries as clinical trial data is a primary information source for competitive intelligence, research planning and clinical study planning. Press release

Cognizant has introduced Cognizant Protocol Creator, a SaaS collaboration product that automates the development of clinical trial protocol documentation. A first for the life sciences industry, Protocol Creator enables clinical teams to create and review protocol documentation in a purpose-built collaborative environment. The software simplifies the production of protocol documents, saving time and ensuring quality through the adherence to industry standards and best practices. Taking a design-thinking approach to the development of Protocol Creator, Cognizant embedded itself with medical writing and clinical trial teams to learn about and address their challenges. With a goal of getting a protocol to submission faster, Protocol Creator generates clinical trial documentation as a structured document. It helps teams collaborate, manage review cycles and deadlines, and enables the final protocol to be published as a traditional document or in machine-readable formats that lay the foundation for downstream automation. "The development of the protocol document is a long-standing target for driving efficiency in our clinical trial processes," Patricia Belissa-Mathiot, Director, Center of Excellence Clinical Operations at Servier, an international and independent pharmaceutical company, governed by a non-profit foundation, headquartered in France, said in a press release. "Cognizant understands the challenges involved in the creation of a protocol and has created a product that addresses most of the processes' pain points, improves the ways of working and offers some future opportunities for downstream activities. It has been exciting to be part of the journey that has led to the launch of Protocol Creator." Press release