July 1, 2019 | June was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Aetion, Kit Check, Shimmer, and more.

Aetion announced a partnership with Horizon to use medical and pharmacy claims data to optimize treatment pathways across nine therapeutic areas. The evidence they generate will support case management interventions and the development of value-based agreements with pharmaceutical companies for specific patient populations. The partners are leveraging near real-time data analytics to identify high-risk members and implement targeted formulary and drug adherence interventions to improve outcomes, building on an initial study performed in 2018 that will now extend to additional therapeutic areas. Horizon is embarking on an initial intervention program targeting 1,500 members with type 2 diabetes, which it estimates will yield better quality for members, and result in $5M in savings per year. "Horizon is dedicated to innovative partnerships that tap into the power of our data to help our members achieve their best health," William D. Georges, senior vice president and chief strategy officer at Horizon, said in a press release. "We started with a diabetes treatment pathway identified by Aetion and the success of that initiative has laid the groundwork to expand our partnership to new solutions that will improve care for even more patients." Aetion offers a technology platform that delivers the real-world evidence needed for biopharma and payers to engage in value-based care. Real-world evidence is generated from health data routinely collected outside of a controlled setting from insurance claims, electronic medical records, patient-reported outcomes, patient registries, and other sources. Press release

Kit Check announced the acceptance of their pilot program that includes partnerships with leading pharmaceutical organizations and health systems to the Drug Supply Chain Security Act (DSCSA) from the Food and Drug Administration (FDA). The focused pilot will enhance requirements for package-level tracing and verification and explore RFID as an alternative data carrier to the 2D barcode. The program, which includes efforts from Hackensack University Medical Center, Coral Gables Hospital, Nephron Pharmaceuticals, and Sandoz, a Novartis division. The goal of this pilot is to demonstrate how an RFID data carrier for electronic data exchanges can bring interoperability and tracking improvements while lowering the costs associated with DSCSA compliance. With RFID technologies in place, all parties involved will be able to exchange product tracing information across the pharmaceutical distribution supply chain, while identifying, managing, and preventing the distribution of suspect and illegitimate products. "Since the implementation of DSCSA in 2015, the FDA has made impressive strides to improve the safety and security of the drug supply chain," said Lou Kennedy, chief executive officer, Nephron, in a press release. "There are powerful technologies operating today, such as RFID, that can significantly improve our industry operations further. We are confident our pilot will shine light on the impact RFID can have on the drug supply chain for years to come and become a standard practice amongst all stakeholders." The pilot will leverage existing 2D barcode monitoring technology and RFID so both methods can be evaluated and analyzed. This will allow participants to show the areas for growth from the existing technologies, while expanding the use cases and supporting data for RFID. The labels and markers will be included on a range of injectable drugs in vials and pre-filled syringes that meet the definitions laid out by the FDA – following their journey from manufacturing through the hospital. Press release

Shimmer and ClearSky Medical Diagnostics announced they are partnering to bring a new level of analytic capabilities to the use of wearable sensors in clinical research. This partnership will employ Shimmer's Verisense wearable sensors platform, which has been designed specifically for use in clinical research, with ClearSky algorithms and machine learning to transform wearables data into actionable insights for central nervous system (CNS) diseases. "The Verisense platform is truly a breakthrough for conducting clinical research," said Stephen Smith, co-founder of ClearSky Medical Diagnostics, in a press release. "It can provide the continuous raw data from wearables needed for sophisticated algorithms, yet places almost no burden on the participant or the clinical site. It has multiple layers of redundancy and quality checking to ensure that high-quality data are collected without interruption." "ClearSky's algorithms can be used with Verisense data right away," Geoff Gill, president of Shimmer Americas, said in a press release. "But what we are really excited about is the potential for our clinical research customers to leverage ClearSky's experience and datasets to develop endpoints for a wide variety of CNS disorders based on Verisense data. ClearSky has taken raw motion data and transformed it with machine learning into actionable insights for physicians in a wide range of applications. This experience is ideally suited to develop endpoints for diseases like Parkinson's, multiple sclerosis, Huntington's, and many others using real-world data." Press release

IQVIA announced the launch of the Patient Centered Endpoints (PCE) solution, an innovative science and technology-enabled approach that captures quantified evidence of patients' experiences during clinical trials and real world studies. This disruptive technology enables trial sponsors to better understand the patients' experiences on various therapies, reduce study implementation timelines, and enhance data transparency. PCE gives life science companies the ability to deploy real-time direct-from-patient data collection solutions in clinical and real world research by integrating IQVIA's scientific services with a secure, electronic clinical outcome assessment (eCOA) on a cloud-based technology platform. The eCOA platform was developed to improve trial experiences for both patients and study teams. "IQVIA is committed to bringing together deep scientific expertise and cutting-edge technology to disrupt clinical development and real world evidence generation," said Jon Resnick, president, Real World & Analytics Solutions, IQVIA, in a press release. "By listening to and understanding the patient experience, we can rethink research in healthcare to enable more patient-centric approaches — ultimately ensuring we are bringing the right medicines to the right patients at the right time." The PCE solution is powered by the IQVIA CORE, which brings together unparalleled data, transformative technology, advanced analytics and deep scientific domain expertise to build and execute clinical outcome assessments with patients top of mind. Designed with patient input, the PCE solution reflects deep knowledge and understanding of what matters to patients about their respective disease and treatment, while protecting privacy by delivering insights on a non-identified basis. Press release

MMS announced the launch of Automatiqc, a new cloud-based application that automatically performs quality control (QC) and style checks for medical writing, pharmacovigilance, clinical trial transparency, and other types of documents in the pharmaceutical, biotechnology, and medical device industries. Automatiqc has proven that it can reduce QC time by up to 33%, drastically reducing the amount of time needed to perform quality checks and allowing teams to meet aggressive QC deadlines. This new application is highly customizable, enabling users to tailor the software to specific client style guides including journal requirements and other established guides. Automatiqc does not require special training and can be easily incorporated into a medical writer’s standard workflow. Automatiqc can be used for any Microsoft Word-based document type including, but not limited to:

• Clinical Study Reports (CSRs)
• Protocols and Investigator’s Brochures (IB)
• Module 2 IND and NDA submission documents (M2.5, M2.7.1, M2.7.2, M2.7.3, M2.7.4, M2.7.5, and M2.7.6)
• Module 5 Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS)
• Health Authority Responses and Response to Queries (RTQs)
• Safety Narratives and Risk Management Plans (RMPs),
• Publications for peer-reviewed journals and more.

"MMS is constantly searching for new, impactful ways to bring innovations, and efficiencies to the pharmaceutical industry, and I think we’ve proven that with the introduction of Automatiqc," said Michelle Gayari, Executive Director, Global Operations, MMS, in a press release. "The current focus for many is related to reducing budget and timelines – Automatiqc does both. We designed this perfectly programmed application to utilize our pharmaceutical industry intelligence to improve the QC process for everyone. QC is the final step before release of a document to regulators or the external environment and this efficiency allows us to be nimble to adapt to last-minute document changes." Press release

New research from Veeva Systems' Veeva 2019 Unified Clinical Operations Survey finds that all (100%) respondents surveyed report the need to improve information exchange among study partners. On average, they utilize at least three methods to share trial data and documents among sponsors, CROs, and sites, with email as the primary tool. Majorities say the move to streamline information exchange is driven by the need to reduce manual processes (71%), improve collaboration (66%), and increase visibility and oversight (64%) during trials. "There is a significant industrywide opportunity to improve study visibility and partner collaboration to speed trial execution," said Jim Reilly, vice president of Vault Clinical, in a press release. "As more sponsors, CROs, and sites focus on streamlining clinical processes and systems, drug development will become more efficient and stakeholders will be better aligned throughout the trial lifecycle." Nearly all sponsors and CROs (99%) say they also need to unify clinical applications for greater visibility (70%) and easier collaboration (61%). Many of the challenges in managing trials stem from siloed processes and systems that prevent a complete view of study progress and slow trial execution. Integration (68%) and reporting (57%) are the top two issues cited – both are the direct result of clinical system silos. Press release

HealthChampion is now fully HIPAA compliant. With the fundamental belief that people should be able to access their own health data as easily as their credit score, HealthChampion is developing an app that enables consumers to do precisely that. In addition, HealthChampion -- from the very beginning -- also focused on the highest level of protection for people's health data. "Health data is personal and highly sensitive. That's why every one of our staff members—from IT to marketing—went through extensive, vigorous HIPAA compliance training. Each new hire will, as well," says Nick Biernat, Manager of Information Services and Compliance at HealthChampion, in a press release. The HIPAA Seal of Compliance is the entire health care industry's third-party HIPAA verification. There is no formal HIPAA compliance certification from the federal government or subsidiary regulatory agencies. US health care professionals rely on companies such as the Compliancy Group to demonstrate their compliance. Press release

Datacubed Health's mobile platform has been selected to support worldwide studies for those at risk of Dominantly Inherited Alzheimer's Disease, a rare form of early-onset Alzheimer's Disease. The Linkt platform enables the collection of real-time data on sleep, diet and other biomarkers using a "bring your own device" (BYOD) study model. Datacubed Health’s app, platform, and web-based portal will be used by scientists at the Dominantly Inherited Alzheimer Network (DIAN) at the Washington University School of Medicine in Saint Louis. The DIAN research incorporates an observational study, clinical drug trials, a research registry and smaller ancillary studies. Datacubed Health's tools will enable researchers to collect data that is more representative of natural settings while reducing participant burden. The app and portal utilize a gamified experience with rewards for completion and compliance. Participants navigate an interactive map journey creating variable rewards such as digital gems and visual progress as they complete articles, surveys and tasks. Datacubed Health's tools allow researchers and study coordinators to enroll participants, monitor real-time progress and compliance dashboards, manage incentives and review study data. The Linkt app and portal will also be used to support a registry for families confirmed or suspected to have the disease and a longitudinal observational study of family members with parents who have the gene mutation associated with the disease. With research suggesting that brain changes occur years before symptoms develop, the goal is to identify these changes in presymptomatic carriers. Ultimately, researchers hope to develop therapies to detect and treat DIAD at its earliest stages – or prevent it altogether. Press release