September 26, 2018 | September was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from TrialScope, Golden Helix, The National Institutes of Health, and more.

Certara announced the launch of its BaseCase Portal cloud-based platform, that allows for the rapid creation of fully-customizable mobile apps that connect live to mathematical models and algorithms, and help HCPs optimize treatment for individual patients. By creating an intuitive front-end, BaseCase Portal enables clinicians to use complex scientific models and algorithms that were previously only available in research settings, to guide therapeutic decision-making. For example, a company can now create an app that runs a mathematical model to generate a dosing recommendation based on individual patient characteristics, and deploy that app rapidly to the HCP’s mobile device using BaseCase Portal. Unique in the industry, Certara provides a full spectrum solution for creating precision dosing apps, by leveraging the company’s expansive model-informed drug development, regulatory science, market access and real-world evidence solutions with BaseCase Portal technology. “With this new platform, Certara ushers in a new era of model-informed precision dosing at the point of care,” said Thomas Kerbusch, president of Certara Strategic Consulting, in a press release. “In fact, Certara is bringing together its strategic drug development, modeling and simulation/pharmacometrics, market access, health economics/outcomes research, regulatory sciences, and interactive mobile app development together to create this user-friendly platform, thus strengthening how our clients deliver treatment to patients.” Press release

TrialScope announced the launch of its Clinical Trial Transparency Service (CTTS). This transparency and health literacy management solution enables clinical trial sponsors to engage with patients, healthcare professionals, researchers and the public via a dedicated clinical trial informational website. The company is debuting this service with three customers that are among the top 20 pharmaceutical companies in the world. As the demand for accurate and understandable clinical trial transparency from regulatory and patient advocacy groups continues to grow, TrialScope's CTTS allows sponsors to position themselves as pioneers in trial data sharing, trial literacy, trial recruitment optimization, patient education and retention. In addition, under the new service, the sponsor's website is automatically updated with information submitted to Clinicaltrials.gov, eliminating redundant processes and associated costs, and improving reporting accuracy. "Today, more than ever, patients are seeking clinical trial information on the web. This, coupled with calls for transparency, highlights a major need in the industry for a way to disseminate important, easy-to-understand information such as plain language summaries (PLS), or respond to data requests," said Jeff Kozloff, CEO of TrialScope, in a press release. "We're excited to share our newest solution with the clinical trial community and look forward to helping sponsors deliver meaningful clinical trial data and clear communications to help patients find, share, enroll and stay engaged in studies." Press release

Golden Helix announced that the National Institutes of Health awarded them a Phase 2 SBIR Grant 2R44 GM125432-02 “Integrating CNV analysis into a NextGen sequencing clinical analytics platform”. This grant was awarded to develop and refine algorithms and applications to detect copy number variants (CNVs) and other structural variations in Next-Gen Sequencing. Also, it allows the company to spearhead further development in combining these types of mutations with clinical interpretation workflows. “The NIH has been a terrific partner and supporter of our company,” stated Andreas Scherer President, and CEO of Golden Helix. “With the help of the approved funds, we will be able to take calculated risks pushing the currently existing boundaries of the clinical interpretation of Next-Gen Sequencing to the next level. The commitment of this grant gives us the ability to focus the next two years on advancements in this area. As the Principal Investigator of this grant, I want to express my utmost gratitude for this funding.” Press release

Athens Medical Group (AMG), including Athens Medical Center, joined Clinerion’s hospitals network, expanding Clinerion’s footprint in Western Europe. Their Medsana Bucharest Medical Center in Romania will also join Clinerion’s Patient Network Explorer platform. Athens Medical Group (AMG) runs eight ultramodern hospitals in Greece, seven in the Athens Metropolitan Area and one in Thessaloniki, Northern Greece. AMG cooperates with an extensive nationwide network of 390 diagnostic centers, eight haemodialysis units and a growing network of official associate centers throughout Greece. A multinational company, it operates Medsana clinics, four modern and specialized diagnostic centers in Romania, which also have presence, through affiliate companies, in North Africa, the Balkan area, Russia and the Former Soviet Union countries. Joining Clinerion’s Patient Network Explorer platform will bring more innovative treatments to the patients of Athens Medical Center’s hospitals and clinics, and give their physicians more options in treating their patients. The group will also gain more exposure to global clinical trials run by international pharmaceutical companies and contract research organizations. Press release

Palantir announced that it has been awarded a three-year, $7 million contract by the National Institutes of Health (NIH). Palantir will deploy its software as the collaborative scientific platform for the National Center for Advancing Translational Sciences (NCATS) and its related organizations. NCATS, one of the NIH’s 27 Institutes and Centers, aims to remove bottlenecks in research pipelines and speed the delivery of new drugs, diagnostics, and medical devices to patients. The organization’s scientists will utilize Palantir’s software to combine proprietary and public research data in one secure interface—screening, genomics, and other high-throughput biological data will be integrated into the platform in order to advance the translational research of NCATS teams. “NCATS’ mission is to get more treatments to patients more quickly,” said Andrew Girvin, Head of Biomedical R&D at Palantir, in a press release. “By bringing together disparate data into one interface, researchers will soon benefit from greater insights in a fraction of the time. Ultimately, the goal is to help accelerate the discovery of new therapies for cancer and other illnesses.” Press release

Roche announced the launch of the first two NAVIFY clinical decision support apps: The NAVIFY Clinical Trial Match and NAVIFY Publication Search apps help oncology care teams access relevant clinical trial information and publications more effectively. Finding the most relevant up-to-date clinical trials and relevant literature is a cumbersome and labor-intensive process. The two launched apps available on the NAVIFY Tumor Board facilitate this process: NAVIFY Clinical Trial Match app identifies clinical trial options based on patient-specific attributes such as age, gender, biomarkers and various tumor information from 11 international registries (incl. ClinicalTrials.gov, German Clinical Trials Registry (DRKS) and European Clinical Trials Registry (EUCTR)). NAVIFY Publication Search app mines publication sources globally (incl. PubMed, American Society of Clinical Oncology, American Association of Central Cancer Registries) for most recent clinically and therapeutically relevant literature. The content of both apps is provided by MolecularMatch, a clinical informatics company with expertise in precision oncology, immunotherapy and bioinformatics. The launch of these first two apps is the start of the NAVIFY apps ecosystem. More apps from Roche, partners and third parties will follow to expand the clinical decision support functionalities. Press release

Clinerion and Semicrol announced a collaboration which will integrate the functionality of Clinerion’s Patient Network Explorer with Semicrol’s Fundanet CTMS. The partnership will integrate patient data throughout the clinical trial process, from planning to reporting of results. The technical and commercial collaboration between the two companies will integrate the functionality of Clinerion’s Patient Network Explorer with Semicrol’s Fundanet Clinical Trials Management System (CTMS), enabling the automated, efficient sharing of patient data from a hospital’s electronic health records system to the CTMS running a clinical trial at that hospital. The collaboration will give clinical trial sponsors and managers unified tools to manage trial data and workflows throughout the clinical trial process, from planning to reporting of results. This will enable a broader approach in clinical trials, drug development support and better outcomes for patients. Patient data privacy is preserved, and patient data remains within the hospital IT infrastructure throughout. Fundanet CTMS is a world-class clinical trial management system designed to provide quick and easy access to study or subject information utilizing simple and intuitive navigation. Patient Network Explorer aggregates patient insights from anonymized patient records throughout Clinerion’s global network of partner hospitals to provide services for clinical trial protocol feasibility, site selection, and patient search and identification, as well as generating real-world data for medical access applications. Press release

Clinerion also announced a partnership with Patient iP to improve clinical trial design, site selection and patient enrollment. The companies will collaborate using Clinerion’s intelligent, patented Patient Network Explorer platform and Patient iP’s proprietary daTAscape asset to better target clinical trial sites and accelerate trial enrollment on a global scale. Clinerion aggregates healthcare information across institutions and geographies from their global network of partner hospitals, creating one single comprehensive real-time view. Clinerion’s network currently includes more than 17 million real time patient lives, with an additional 55 million lives contracted and in implementation, across more than 100 hospitals in the Americas, Europe and Asia. Used in combination with Patient iP’s platform which contains more than 16 million ambulatory electronic medical records (EMR) across 5,000 practice sites, the partnership will bring remarkable improvements to clinical trials. Press release

Definiens announced that it has entered into a multi-year digital partnership agreement with Merck to support Merck’s exploratory and clinical development programs using Definiens TissuePhenomics solutions for quantification of biomarkers including immuno-profiling. “This partnership agreement is a testament to Definiens ability to transform tissue image data into valuable insights using our proprietary data mining methods for biomarker discovery,“ said Oliver Lehner, Definiens VP Business Development and Partnering, in a press release. Under the agreement, the healthcare business sector of Merck will use the Definiens novel web-based collaboration software platform that enables Definiens customers to upload, access, explore and share data and will benefit from a dedicated team to maximize synergies between its projects. The partnership with Definiens will foster digital transformation in R&D and support Merck in taking informed decisions with regard to its immuno-oncology product development portfolio based on high quality tissue diagnostics and biomarker data. Press release

Mellitus Health and Smart Meter announced a strategic partnership that will bring real-time, accurate blood glucose data to insulin titration. Through the partnership, healthcare providers using the Insulin Insightsä titration service will now have access to real-time patient data from Smart Meter's iGlucose Cellular Diabetes Care solution to help calculate precise insulin dosing recommendations for patients. The integration of the two technologies will help healthcare teams achieve HbA1c targets and better patient outcomes. Press release

Caris announced that the company has been selected by the Hoosier Cancer Research Network and the study's sponsor investigator, Matthew Galsky, to perform genomic tumor profiling for a new Phase II bladder cancer clinical trial, HCRN GU16-257. This marks the second tumor profiling study Caris has been selected to lead within the Hoosier Cancer Research Network. The study, "Neoadjuvant Gemcitabine, Cisplatin, Plus Nivolumab in Patients with Muscle-invasive Bladder Cancer with Selective Bladder Sparing," is seeking to define the safety and activity of multi-combination therapy of gemcitabine, cisplatin, plus the immuno-therapy nivolumab (Opdivo) as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response in predicting benefit in patients opting to avoid cystectomy. Bladder cancer is the sixth most commonly diagnosed cancer in the U.S., with more than 79,000 new cases and 16,800 deaths estimated in 2017. The current standard of care for patients with muscle invasive bladder cancer is a radical cystectomy, or removal of the bladder, which carries with it non-desirable side effects and long-term impact on quality of life. The HCRN GU16-257 trial seeks to determine if the combination of chemotherapy and immunotherapy could be a substitute for this type of surgery for patients carrying certain mutations in DNA repair genes such as ATM, RB1, FANCC, and ERCC2. Caris will identify and report molecular aberrations via Next-Generation Sequencing of 592 DNA genes and genomic signatures, which include Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI). Caris will also extract tumor DNA and RNA for future study to help determine which biomarkers in the tumor best correlate with patient response in the trial. Press release

Over the past year, growing numbers of customers are adopting Veeva Vault CTMS to empower clinical teams with one complete source of trial information for faster study execution. Vault CTMS is a next-generation cloud application from Veeva Systems that unifies end-to-end information and processes for greater visibility throughout the trial lifecycle. In 15 months since the product’s availability, 28 sponsors and CROs have selected Vault CTMS and 18 customers are already using the product to streamline clinical operations and improve trial performance. “CTMS solutions have held the industry back for decades, and the industry is recognizing the tremendous opportunity to improve efficiency throughout its operations,” said Henry Galio, senior director, Vault CTMS, in a press release. “Veeva Vault CTMS is finally giving customers a new, innovative approach to CTMS for more efficient and effective trials.” A recent survey shows that challenges with current CTMS applications are limiting trial operations for the majority of life sciences companies. Greater visibility is a top driver for clinical operations professionals to improve the use of CTMS. Press release

CRF Health announced that its TrialMax Slate solution has been selected by a US biotech company for a global Phase III prostate cancer study. The large-scale trial will involve up to 1,000 screened patients across 75+ sites and 10+ countries. The therapy targets an aggressive form of prostate cancer, where other treatment options have failed, involving seriously ill cancer patients. This sponsor required an electronic clinical outcome assessments (eCOA) provider to support their goal of collecting clinical endpoint data electronically to uphold data quality and integrity; and to ensure that the solution simplified site activities and was able to address the challenges associated with patient-reported outcome measure (PROM) completion in clinical trials involving very ill patients. TrialMax Slate is designed to make site-based eSource data collection easy for site teams and patients. The dedicated tablet solution ensures the correct instruments are delivered at the appropriate study visits, reducing protocol compliance errors, and enhances data quality and completeness through in-build logic checking. Using the tool reduces site administrative burden associated with PROM and clinician-reported outcome (ClinRO) data collection, and ensures data is available for clinician review in real-time during each patient visit. In oncology studies, particularly those involving very ill patients or those exposed to treatments with severe side effect profiles, patients face unique challenges in their ability to complete elements of the study. This could be as a result of experiencing pain, fatigue, nausea or other aspects related to their condition or its treatment while being asked to provide responses to one or more PRO instruments. TrialMax Slate’s easy-to-navigate interface helpfully guides instrument entry, enables patients to stop and re-start where necessary, and provides a portable solution that allows patients to complete sensitive questionnaires comfortably, privately and accurately. Press release