July 31, 2019 | July was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from IBM, Solve.Care, Greenphire, and more.

IBM, KPMG, Merck, and Walmart announced that the companies have been selected by the United States Food and Drug Administration (FDA) to be included in a program in support of the US Drug Supply Chain Security Act (DSCSA) that addresses requirements to identify, track, and trace prescription medicines and vaccines distributed within the United States. The program is intended to assist drug supply chain stakeholders, including FDA, in developing the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States. "Our supply chain strategy, planning and logistics are built around the customers and patients we serve," Craig Kennedy, senior vice president, Supply Chain, at Merck, said in a press release. "Reliable and verifiable supply helps improve confidence among all the stakeholders—especially patients—while also strengthening the foundation of our business." Each company brings unique expertise to the project, which will create a shared permissioned blockchain network that allows real-time monitoring of products. The proposed network is intended to help reduce the time needed to track and trace inventory; allow timely retrieval of reliable distribution information; increase accuracy of data shared among network members; and help determine the integrity of products in the distribution chain, including whether products are kept at the correct temperature. Press release

Solve.Care has announced a partnership with Uber Health, allowing healthcare organizations to provide accessible and affordable rides to patients and caregivers. The partnership will result in the integration of Uber Health’s transportation solutions into Solve.Care’s Care.Wallet, a personal healthcare coordination and administration application. Through the Care.Wallet, patients will be able to schedule Uber Health’s HIPAA compliant rideshare product to preapproved and predetermined care appointments, without the need for the Uber app or even a smartphone, immediately or for specific day of the appointment. Dan Trigub, Head of Uber Health, said in a press release: "Every year, an estimated 3.6 million Americans miss their medical appointments due to a lack of reliable transportation, with the cost of missed primary care appointments estimated at $150 billion annually. At Uber Health, we are always looking for ways to ensure that transportation is not a barrier to care. Via our HIPAA compliant solutions, we are working to facilitate rides for patients who might not have access or the ability to use smartphones and to improve access to care for patients with mobility issues. Our partnership with Solve.Care supports our efforts by bringing innovation to the healthcare space and driving greater accessibility to care for patients." Press release

Greenphire announced that it has been selected by Atlantic Research Group (ARG) to implement its ClinCard and ConneX solutions to improve the clinical trial experience for sites and patients. ARG will begin using Greenphire's participant reimbursement solution, ClinCard, and travel solution, ConneX, to improve patient retention and further accommodate individuals with limitations or special requirements. "Rare diseases and cancers are very challenging for families, especially when the patients are children. To ask parents to be in charge of international travel and logistics while caring for a child enduring a disease, treatment and suffering is simply too much," Catherine Allen, Project Manager, ARG, said in a press release. "That is where Greenphire comes in, providing hassle-free and risk-free travel. This service helps all stakeholders. ARG identifies the right patients to participate in clinical trials, regardless of where they live, and gets them to the study centers. By reducing administrative work, Greenphire enables study staff to stay focused on patients and study visits. The families, in turn, focus on trials and treatments. The end result is enhanced engagement for everyone throughout the entire process." Press release

Phesi has launched ClinSite, a self-service, artificial intelligence (AI)-powered tool that enables biopharmaceutical companies to search for and select top-performing investigator trial sites for clinical trials in all therapeutic areas, including rare diseases. ClinSite, a Software as a Service (SaaS) solution that incorporates natural language processing and machine learning, is an evolution of the technology Phesi patented in 2007 and fully automated in 2018. Phesi’s technology platform incorporates data from 4.2 million physicians and 600,000 investigator sites, identified from 80,000 sources and 330,000 clinical trials in 240 countries, and growing. Investigator sites selected through this platform in more than 250 clinical trials have enrolled up to 40% faster than other sites, saving millions of dollars per trial. Press release

ThoughtSphere announced that Navitas Life Sciences chose ThoughtSphere to power OneClinical Analytics, which is an intelligent digital, clinical analytics platform. "With ThoughtSphere as our partner, our OneClinical analytical platform delivers best-in-class clinical trial oversight and actionable insights for faster decision making. Enabled by AI and Machine learning, the smart mapper provides unparalleled data collation and aggregation to significantly reduce the cost in mapping highly complex studies. OneClinical is the only platform with workflow enabled issue management that empowers our clients to lower any risks to their clinical trials," said Ram Yeleswarapu, President and CEO of Navitas Life Sciences, in a press release. Over the past year ThoughtSphere has added a number of pharmaceutical companies to its customer base. ThoughtSphere has also released significant new capabilities in its ThoughtSphere Cloud Platform. Press release

PHASTAR announced that it has entered into a technology partnership with Medidata. PHASTAR will deploy several solutions from the Medidata Rave Clinical Cloud including Rave EDC, Coder, eCOA, and RTSM. The adoption of the Medidata Rave Clinical Cloud comes as PHASTAR continues to grow its market share in data services. PHASTAR has expanded its Data Operations teams in Kenya and the UK to provide professional services, and, with the opening of its second US office in Boston, its partnership with Medidata will further power its US expansion. "We are excited to partner with PHASTAR in its mission to support the pharmaceutical and biotech sector in safely bringing new therapies and medical devices to patients," Glen de Vries, co-founder and president, Medidata, said in a press release. "Our unified platform will enable PHASTAR to design and conduct complex clinical trials and turn large volumes of data into insights." Press release

PerkinElmer announced its NeoLSD MSMS Kit, the first commercial mass spectrometry based IVD kit for newborn screening of up to six lysosomal storage disorders from a single blood spot punch, has received approval from the US Food and Drug Administration (FDA). The kit is to be run on the company's QSight 210 MD system. The NeoLSD MSMS kit is unique because it not only enables clinical laboratories to test newborn babies for lysosomal storage disorders (LSDs) from a single dried blood spot punch—but, it also allows them to process higher volumes of samples more efficiently. Full FDA announcement

Certara announced that the entire staff from Compass has joined Certara's Evidence & Access group. Certara Evidence & Access was formed through the acquisition of Analytica Laser (market access, health economics and real-world evidence consultancy) and BaseCase (life sciences value communications technology company). The Compass team, which has partnered with Analytica Laser previously, is based in New Haven, CT. "The Compass team is highly experienced and brings new depth and capabilities to Certara Evidence & Access," Roman Casciano, SVP of Certara Evidence & Access, said in a press release. "Compass specializes in developing and executing strategies to achieve drug access and price objectives in the US and global markets, including initial price setting, quantitative launch pricing, contracting strategies, and payer segmentation. Compass has also built a due diligence practice that can respond rapidly to deal demands, which will be of immediate benefit to our customers. Compass' extensive analyses of early-stage clinical opportunities and market landscapes, and assessments of pipeline assets fit well with Certara's Evidence & Access core strengths in building product value propositions and evidence to support health technology assessments." Press release