January 30, 2020 | January was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from LabCorp, Medial EarlySign, Color, and more.

LabCorp introduced its focused and coordinated suite of cell and gene therapy development solutions from Covance, its drug development business. These solutions are designed to reduce time and risk for sponsors at each phase and across the full continuum of their therapy development needs in one of the industry’s fastest-growing segments. Covance provides a unique offering of specialized expertise and coordinated capabilities, combined with focused investments supporting the preclinical, clinical and post-approval phases of development. By offering a coordinated approach to scientific and program consultation, biomarker and companion diagnostic development, study management, regulatory and commercialization support capabilities, Covance is uniquely positioned to partner with sponsor organizations to address complexity, reduce cost and risk, and effectively accelerate timelines of their novel therapies. Press release

Medial EarlySign announced its flu complications algorithm has been selected by Maccabi Healthcare Services as part of the Israeli healthcare organization’s integrated strategy to enhance its flu vaccination campaign. The EarlySign investigational algorithm flags individuals at high risk for developing flu-related complications and is being used as part of a clinical study undertaken by Maccabi and EarlySign. EarlySign’s machine learning-based tool applies advanced algorithms to ordinary patient data, collected over the course of routine care. The flu complications algorithm uses this EHR data to identify and stratify unvaccinated individuals at high risk of developing flu-related complications, often requiring hospitalization. Maccabi's clinical study using EarlySign's flu complications algorithm supports the Israeli HMO's commitment to investigating and implementing machine learning-based solutions to improve the health of populations. The program follows Maccabi's initial collaboration with EarlySign in 2016, to identify individuals at high risk of colorectal cancer who are non-compliant with screening guidelines. Press release

A year after Color and NorthShore announced their partnership to integrate clinical genomics into routine primary care, the two organizations have completed the largest U.S. genomics program to date. The partnership will expand in 2020 to 30 additional clinics within the NorthShore system and its newest partner, Swedish Hospital, while integrating more sophisticated information into clinical care including predictive polygenic risk scores for type 2 diabetes and coronary artery disease. The program, DNA-10K, has met its goals of enrolling 10,000 participants and providing patients with actionable clinical genomic results, including risks for cancer, heart disease and how genes affect responses to medication. This partnership incorporates clinical genomic results into patients’ electronic medical records (EMRs), where real-time alerts allow providers to leverage genomic insights at the frontlines of care for long-term actionability and enhanced decision making by physicians and providers at NorthShore. “We’ve built a model of Advanced Primary Care that is transforming the delivery of healthcare,” said J.P. Gallagher, President and Chief Executive Officer of NorthShore, in a press release. “We’ve seen firsthand that genetic information is a foundational part of healthcare for all patients. Clinically relevant findings provide lifesaving information that physicians can immediately use to diagnose, treat and even avoid diseases.” The integration of cancer and cardiac insights, combined with pharmacogenomics, into clinical care via NorthShore’s EMR platform has proven to be a key component of the integrated approach and is generating significant value in patient care. Press release

Spry Therapeutics announced its plan to reduce the spread of healthcare acquired infections (HAIs) among patients and caregivers. Through its 2020 Pure campaign, Spry hopes to address the HAI epidemic, which claims 99,000 lives in the US annually—more than breast and prostate cancer combined—with its patented filtered technology, Pneumapure. The company’s patented filter technology blocks even the smallest “superbugs”—down to .02 micron—from entering or exiting any soft surface to which it’s applied, helping to prevent the transmission of deadly diseases among patients and caregivers. Pneumapure also reduces costs associated with HAIs from environmental impact to disposal costs, annual purchase expenditures and more. “We are excited about the prospect of finally being able to prevent infections that are killing hundreds of thousands of people a year by offering an effective and affordable technology,” said Bill Purdy, Co-Founder and CEO of Spry Therapeutics, in a press release. “We strongly believe that patients should have the expectation that their head rests on a pillow with a core that has not been contaminated by a previous patient. We also believe that suppliers and manufacturers of these pillows have an obligation to meet that expectation, whenever possible.” Press release

Greenphire announced that it has expanded its ConneX global travel solution to include additional in-market support and visa fulfillment services. ConneX is designed to meet the retention goals of global clinical trials by offering concierge travel services that deliver added convenience and a better experience for patients, families, caregivers and sites. The recent ConneX enhancement includes an expanded footprint with a global network to provide in-market, local language, and time zone travel arrangements for every major clinical trial market worldwide. Backed by a team of experts in both travel and clinical research, ConneX can be tailored to accommodate each participant's unique logistical requirements, providing patients, their families and caregivers peace-of-mind while traveling away from home. Services range from local transportation (e.g. rideshare) to complex, international travel, including car (taxi, black car, white glove / specialized transportation, and ambulatory care), train, air, and hotel accommodations and more. Press release

Signant Health has announced new audit trail reviewing and reporting functionality for its electronic clinical outcome assessment (eCOA) and remote sensor platform, TrialMax. This new functionality enables authorized personnel to simply and quickly access and explore key audit trail data through interactive reports and dashboards in just a few clicks. The efficiencies are realized through TrialMax’s ability to track user actions and inputs in real-time, automatically creating a behind the scenes audit trail as users interact with the tool, and through leveraging Signant Health's enterprise analytics platform. Signant Health developed TrialMax’s latest audit features in consultation with users and clients responsible for clinical oversight and data management in order to ensure compliance with data integrity guidance and definitions from the FDA, EMA and MHRA. These latest features provide TrialMax users with standardized key performance indicators (KPIs) on data updates, removals and original entries; dashboards featuring data visualizations to support the fast identification of key data integrity metrics; dynamic filtering and interactive graphs to analyze the data and reconstruct the course of events as a part of the audit trail review process; the ability to demonstrate clinical data comply with regulatory ALCOA (attributable, legible, contemporaneous, original and accurate) data integrity principles; and detailed audit trail access for user accounts, roles and login activity on Signant Health’s study portal, TrialManager. Press release

Nuvisan announced its acquisition of Inamed. This acquisition gives Nuvisan access to patient populations that are very difficult to recruit, such as patients with cystic fibrosis. Inamed is also one of very few CROs in the world offering orally inhaled products flow-profile studies with a combination of all the associated skills under one roof (technical preparation of devices, flow-profile measurements, in-house clinical performance and management of some external pediatric sites). Over the past several years, Nuvisan and Inamed have built up a close partnership through collaboration on a number of services for their customers. This new merger is the logical next step in this long lasting, successful cooperation. The Inamed site has 28 specialist staff and is located on the periphery of Munich. It has an in-house clinical pharmacology unit of 24 beds, plus six intensive monitoring beds. The short distance to the Nuvisan headquarters ensures steady personnel exchange and just-in-time logistics between the sites. “With Inamed’s capabilities, we are adding specialist expertise in the fields of both respiratory and combined multi-center studies. We will extend our services in patient clinical trials and increase our overnight facilities to 160 beds across the two sites,” Ralf Wulkow, executive vice president, clinical services, at Nuvisan, said in a press release. “The Inamed acquisition is the next step in our continuous growth strategy, which will help us become an ‘all pharma services’ company in the field of early stage drug development for the pharmaceutical industry.” Press release

French digital health company Withings has unveiled its latest smartwatch dubbed ScanWatch, which will include an ECG and Sp02 sensor. The watch comes with a PPG sensor, which will continuously monitor the user's heart rate and alert users if there is an irregularity. If any issues are detected, the watch will prompt the user to take an ECG reading. Watch wearers can read the ECG on the screen of their watch or in the watch’s accompanying Health Mate app. The app can store the reading and any notes that go along with the reading. Currently the technology’s ECG feature is being reviewed by the FDA. Meanwhile the Sp02 feature will be able to measure oxygen continuously and help identify sleep apnea. Press release