August 29, 2018 | August was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from ERT, Certara, Evidation, and more.

The Pistoia Alliance announced a number of milestones in its Chemical Safety Library (CSL) Service project, launched in March 2017. The CSL, which captures, stores and shares hazardous reaction information to improve laboratory safety, has seen a four-fold increase in the number of chemical incidents recorded, with a total of 138 reactions now added. In the year since its launch, over 1,000 people have registered to access the CSL database. Furthermore, all chemical reaction data in the CSL is now available in PubChem, NBCI’s database of chemical compounds used daily by researchers, scientists, and academics, with new CSL Service incident data automatically added to PubChem. “The Chemical Safety Library has had a fantastic start - with the number of registrations showing the scientific community’s interest in ways to ensure lab safety,” commented Steve Arlington, President of The Pistoia Alliance, in a press release. “Safety is everyone’s responsibility, but this type of crowd-sourced, community-based sharing is most valuable when users are engaged and involved. We are continually working to ensure the service is user-friendly, and we are now looking to collaborate with a strategic partner to continue developing the CSL. The Pistoia Alliance’s belief is that collaboration improves every area of research and development in life sciences - from innovation in lab safety to adopting next generation technologies like AI. Ultimately, this will help researchers meet the greatest unmet needs in areas such as precision medicine.” The CSL Service is a resource for researchers to check chemical reactions and share previously inaccessible hazardous reaction info, with the hope of preventing repeat chemical incidents. Its role has been extended further as the scientific community develops the “Lab of The Future” (LoTF). The Pistoia Alliance hosted its annual President’s Series Hackathon earlier this year to encourage stakeholders from the life sciences, healthcare and technology industries, as well as academia, to use the CSL Service data alongside technology that will feature in the LoTF. A group from the University of Southampton won the hackathon by integrating CSL data into Amazon Alexa - giving researchers the ability to simply speak to their surroundings for safety data. As the LoTF advances with new innovations, being able to access data in new ways - such as voice - will become invaluable to researchers. Press release

ERT announced the appointment of Zaher El-Assi as Executive Vice President and Product Line Executive for electronic Clinical Outcome Assessments (eCOA). In this role, he is responsible for defining and leading the product strategy for ERT’s eCOA solutions and services. El-Assi brings more than two decades of global business acumen to ERT, including senior management roles in the clinical research, healthcare, and drug development industries. Previously, El-Assi was Vice President, Global Commercial Leader at Watson Health, a division of IBM, where he led global sales and innovation for the company’s Oncology and Life Sciences business unit as well as its Consumer Health and Ecosystems group. “I’m delighted to join ERT at this pivotal time, when technological advances are helping clinical trial sponsors overcome many of their biggest development challenges,” said El-Assi in a press release. “ERT’s proven eCOA solutions help our customers to abandon traditional, error-prone paper methods and easily implement a modern, quality-driven approach to clinical trial data capture so they can improve clinical trial efficiencies and get new therapies to market faster.” Press release

Certara announced the launch of D360 v10.5, the first in a series of releases focused on delivering biologic-relevant tools together with D360’s world-class data access capabilities. This latest release of Certara’s D360 self-service data informatics platform upgrades the efficiency and consistency of data-driven biologics research workflows for drug discovery scientists, adds a new multi-parameter scoring capability, and improves data analysis and visualization across all modalities. With the advent of recombinant DNA technology and biomanufacturing, therapeutic discovery projects increasingly center on biologic modalities, especially oligonucleotides. The worldwide biologic drugs market is estimated to be valued at more than $200 billion, growing at a rate of 10% per year. While informatics systems for capturing biologics data are maturing, scientists often lack the tools required to understand and prioritize these entities efficiently, relying on manually-curated spreadsheets for crucial decision making. “While many of our customers use D360 for biologics and small molecule research already, this latest release delivers discovery tools that significantly strengthen the platform’s oligonucleotide capabilities and workflows. We have also incorporated feedback from thousands of D360 users to fine-tune workflows and usability across modality types, allowing scientists to focus on the data and science instead of the software they are using,” said David Lowis, senior director of D360 at Certara, in an official statement. Press release

CRF Health launched a self-service capability and a customer enablement program to empower CROs and Sponsors to manage all aspects of electronic informed consent using a licensed, cloud-based version of the industry’s first electronic informed consent platform with fully embedded design tool. With TrialConsent, pharmaceutical companies, CROs and sponsors can leverage their own in-house expertise to develop and implement informed consent documentation and enjoy the advantages of electronic implementation. Self-service licensed users have full access to TrialConsent Designer, an intuitive and visual design environment to develop and collaborate on informed consent documentation and forms.  This web-based design environment provides the capability to rapidly develop documentation, embed multimedia, manage versions for different countries and sites, seamlessly implement translations, and manage the review and approval process of the patient-facing materials. Self-service users of TrialConsent Manager also have the capability to fully monitor study performance and metadata, and to manage the access rights of all study participants. CRF Health’s unique enablement program, tailored separately for Sponsors and CROs, ensures effective onboarding of the solution by providing a comprehensive training and mentoring program and ongoing support to ensure the solution is used effectively. Combined with optional services such as device procurement and logistics, this provides Sponsors and CROs with all they need to independently implement electronic informed consent using their own in-house expertise. Press release

Evidation announced that it has raised $30 million in Series C funding. The round was co-led by SV Health Investors, a new investor, and existing investor B Capital Group. It included participation from existing investors GE Ventures and Sanofi Ventures. With this funding, Evidation has raised a total of $61 million. Evidation also announced that it launched a new data platform to enable its customers to analyze and process large-scale sensor and behavior data in clinically meaningful ways. “Our new data platform makes it easier for statisticians and data scientists at life sciences and health care companies to take everyday behavior and health care data, analyze it, and create a new understanding of health,” said Evidation Health CEO Deborah Kilpatrick, in a press release. “This will help Evidation speed a transformation in real world research and knowledge, so we can better treat, diagnose, and predict the onset of disease.” Press release

Smart Meter announced its integration with Validic, the healthcare industry's leading data connectivity platform. Together, the companies bring a simple, convenient and affordable diabetes management solution to people with diabetes, healthcare teams and population management programs. The iGlucose solution, which uses cell-enabled technology to automatically transmit real-time blood glucose results, removes complex technology issues by automatically transmitting real-time blood glucose (BG) results that can be viewed and acted on by a healthcare team. With the integration of iGlucose into the Validic platform, health systems and corporate wellness leaders can now offer an effective diabetes management program that fits easily into busy lives. When an iGlucose user checks their blood glucose, the healthcare team can receive near real-time, actionable data and has the information to confidently treat their patients. This integration demonstrates Validic's ongoing commitment to deliver personal health data simply and seamlessly into the healthcare system and to continue to build connections to market-leading connected medical health devices and wearables. By providing tools that enable the access to and analysis of personal health data, Validic powers scalable, personalized and data-driven wellness and remote care programs that offer organizations a critical competitive advantage in an increasingly crowded market. Press release