August 31, 2017 | August was full of exciting news in the clinical trial and healthcare community, including partnerships and products from Clinerion, Novartis, RxEOB, and more.
RxEOB has authored the case study, “Utilizing RxEOB MercuryMessaging to promote mammograms.” The RxEOB case study highlights how health care plans wanting to increase the percentage of appropriate patients getting mammograms can do so through better and effective communications using a patient-centric messaging platform. The American College of Radiology and American Cancer Institute both recommend regular mammograms in women beginning at age 40. Unfortunately, for a variety of reasons, the percentage of women who receive an annual mammogram is only 65%. According to the RxEOB case study, “Health plans are interested in improving their mammogram screening rates because it is critical for early detection of breast cancer and for patient health.” It goes on to say, “RxEOB MercuryMessaging maximizes the digital connections and does so with minimal message noise and false positives.” Press release
Clinerion has redesigned the web application for Patient Recruitment System, creating a sleek, professional and intuitive new user interface with analytical capabilities. The system’s functionality and speed have been improved, further supporting decision-making for clinical trial site selection and recruitment strategies. The Patient Recruitment System (PRS) web application has been completely redesigned, using state of the art web design principles based on Material Design. It now incorporates new functionalities and improvements in ease-of-use, resulting in a modern, visually attractive, intuitive and user-friendly appearance. The entire application can now be used on touch displays. Press release
Novartis announced the launch of a mobile research study for people with multiple sclerosis (MS) that collects data via their smartphone, without the need for clinic visits. The study, Evaluation of Evidence from Smart Phone Sensors and Patient-Reported Outcomes in Participants with Multiple Sclerosis (elevateMS), is designed to collect sensor-based data from physical tasks and symptoms. It aims to improve understanding of the daily challenges patients with MS can have and to uncover new potential measurements of treatment effectiveness through real-time data collection from participants in their everyday life. The elevateMS study, which was developed in partnership with Sage Bionetworks, uses a mobile application that was built on the Apple ResearchKit platform. This emerging digital smartphone research platform allows study participants to contribute to research from home or on the go. At the same time, it enables researchers to collect data in the participant’s everyday environment. Press release
Certara announced that it has added externalization technology to its D360 scientific informatics platform. The resulting new product, D360 Partner, facilitates collaboration between sponsors and their external research partners. Those external collaborators could include academic institutions, contract research organizations or third-party research groups. Those partners all have similar data access and communication requirements to members of an internal research project. “Prior to the launch of D360 Partner, this type of collaboration required a custom solution, posing challenges both from an information technology and an informatics perspective. Our new solution provides external research partners with highly secure access to only authorized project data,” David Munro, president, Phoenix Technologies at Certara, said in a press release. Press release
CHRISTUS Health System announced the initial results of the system-wide transition from manual patient intake to Epion Health’s integrated digital check-in platform, using iPads to check patients into their appointments. The move represents a significant step for CHRISTUS, impacting all of its clinic locations across Texas, Arkansas and Louisiana. The Epion Check-in solution provides bi-directional integration with athenahealth, CHRISTUS Health’s electronic health record (EHR) provider, 100% data security and a robust rules engine. EHR integration empowers patients to review and edit existing personal health information already in the system, while adding information to the record appropriate for their scheduled appointment, saving significant time at check-in. Press release
Mauna Kea Technologies announced the peer-reviewed publication of a clinical study demonstrating improved early stomach cancer detection with Cellvizio2 in Endoscopy, the official journal of the European Society of Gastrointestinal Endoscopy (ESGE) and affiliated societies. The new data builds on a recently published meta-analysis3 of Cellvizio in stomach cancer and further establishes the superiority of biopsies guides by a combination of endoscopic imaging with Flexible spectral Imaging Colour Enhancement (FICE) and probe-based confocal laser endomicroscopy (pCLE) with Cellvizio, compared to standard FICE without pCLE for in vivo detection of pre-cancerous and cancerous gastric lesions. Press release
Medisafe announced the official launch of Medisafe Insights. Eclipsing 4 million users and 1 billion doses managed, Medisafe is turning its database of patient information, combining demographics, medication details, medical conditions and comorbidities, engagement with content and interventions, and other key information, into actionable insights for pharma. Medisafe Insights is a proprietary tool for market research (HIPAA compliant and ISO secure), which provides the pharmaceutical industry real-time information regarding patient behavioral trends impacting medication management. With a suite including a de-identified dashboard of high level trends, a targeted and context-aware survey tool and custom enterprise solutions, Medisafe Insights reveals obstacles throughout the patient journey and enables pharma to turn patient behaviors into aggregated actionable insights. The launch of Medisafe Insights comes one year after announcing its commercial offering for pharma and life sciences companies and launching several successful pilot programs. Press release
SERMO announced a new feature for its pioneering Drug Ratings platform. In addition to allowing physicians to rate and review prescription drugs according to their own clinical experiences, SERMO Drug Ratings now enables physicians to search for and research prescription drugs by FDA-approved indications. “Drugs don’t walk into the doctor’s office – patients with conditions do. Doctors tend to think of the patient’s condition first and then think of the available treatment options. Now that physicians can search the Drug Ratings database by indication, they can discover the highest ranked treatment approaches for each indication as well as evaluate how peers rate all approved drugs against each other,” said SERMO CEO Peter Kirk, in a press release. “Drug ratings for doctors, by doctors are an entirely new resource in medicine, enabling doctors to discover new and physician-preferred treatment options for patients in real time.” With the new feature physicians can evaluate different classes of drugs against each other for treating specific conditions, or compare unique brands. They can examine the drug’s overall rating, as well as see how other physicians rank classes and drugs on efficacy, safety, tolerability, accessibility, and adherence. This enables doctors to find information as quickly or in as much detail as they need. Press release
Natural Language Processing (NLP) text analytics provider Linguamatics, and RealHealthData announced their strategic partnership to combine Linguamatics’ advanced NLP technology with RealHealthData’s extensive database of detailed provider narratives, to improve the understanding of drug use, adverse events, and product switching in Real World settings. Understanding the real world (i.e., outside of clinical trials) impact of therapies on patients is critical for pharmaceutical and biotech companies. Medical records are one of the key sources of real world data, and provide evidence that can inform all phases of drug development. RealHealthData provides access to patient narratives from all 50 US states and every medical specialty. The data can be used for all phases of drug development and post marketing research. Linguamatics I2E can be used to extract the key facts from these narratives using relevant ontologies and queries, transforming real world data into actionable intelligence for better decision making. Press release
Firma Clinical Research is pleased to announce its contribution to the FDA approval of Melinta Therapeutics’ lead antibiotic, Baxdela (delafloxacin), for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Firma was selected by Melinta to provide clinical pharmacology consulting, medical writing, and statistical services for the clinical trials and regulatory submission of their drug Baxdela. “We’re thrilled to support the Melinta team in this FDA approval, and gratified this product will be available for patients suffering with ABSSSI,” noted Christina Fleming, Chief Scientific Officer and President, Clinical Research Services for Firma, in a press release. “Applying our specialized services to provide direct client value is what our team members strive to accomplish.” Press release
Clinipace Worldwide has launched a new regulatory and strategic development consultancy called RSD Global Consulting (RSDGC). With more than 50 specialists, Clinipace RSD Global Consulting provides strategic consulting and regulatory support in the United States, Europe, and Asia Pacific. RSDGC offers stage-specific solutions for all phases of development, from non-clinical and clinical, through to marketing applications and post-marketing support. The group also provides all aspects of pharmaceutical development support, including chemistry, manufacturing, and controls (CMC) strategy; dossier preparation ; pre-approval inspection (PAI) preparation; GxP auditing for compliance in pre-clinical (GLP), clinical (GCP), manufacturing (GMP), medical/regulatory writing, strategic biostatistics and a quality assurance (QA) consultancy.
