February 12, 2024 | The days leading up to the Summit for Clinical Ops Professionals—SCOPE—are a busy time for the clinical trials and clinical research space. The event kicked off yesterday and so far we’ve gathered these company and product news. –The Editors
PicnicHealth has launched a new study portal to facilitate faster, more accurate observational research. This fully validated portal will serve as a gateway to conducting virtual and hybrid studies on the PicnicStudies platform. PicnicHealth has run dozens of registries and studies on the PicnicStudies platform, which was built to help life science companies conduct efficient end-to-end observational research with minimal need for traditional sites. PicnicStudies does this by engaging directly with consenting patients to collect data from all of their healthcare interactions and to conduct surveys on patient and clinician reported outcomes. The new portal is tailored for each study and provides real-time insights on study status and progress. By making these data, which include adverse events, protocol deviations, patient screen fails, and patient diversity, more readily available, the portal helps life science companies make faster, more informed decisions about their studies and reduce the risk of delays.
At SCOPE: PicnicHealth is at booth #1132
H1 has launched GenosAI Pro, a new addition to its conversational AI toolkit. Accessed inside of H1’s Trial Landscape platform, this next-generation tool transforms text and data into visual insights and actionable deliverables that help feasibility teams prepare diversity plans, healthcare provider (HCP) and site biobooks, and presentation slides for trial design meetings or diversity plan development sessions. GenosAI is the conversational AI backbone powering all H1 solutions. Building on the success of GenosAI Lite released in 2023, the new GenosAI Pro brings even more advanced AI-powered features and capabilities to Trial Landscape. The system is built on OpenAI ChatGPT Enterprise, keeping data private and secure while delivering the most powerful conversational AI tool available to pharmaceutical companies, streamlining workflows, improving data-driven decision making, and ultimately optimizing clinical trial processes.
At SCOPE: H1 is at booth #923
Tasso has just launched Tasso Care for Prescreening, an end-to-end services solution to maximize the success of a prescreening program. The new offering expands the foundation and expertise of the Tasso Care services platform in remote blood collection and analysis to support clinical trial recruitment. Tasso Care for Prescreening is designed to support the prescreening of trial participants for a number of cardiometabolic and serostatus markers. Additional panels to support immunology, cardiovascular disease, and other therapeutic areas will launch as part of the prescreening platform throughout Q1 of 2024 as validation protocols are completed. Tasso Care revolutionizes the enrollment process by replacing time-consuming, labor-intensive clinic visits with convenient, automated prescreening testing at scale. By providing a virtually painless blood draw experience from home, Tasso drives higher clinical trial engagement rates by simplifying the operational process, optimizing the participants’ blood collection experience, and ensuring a high-quality sample is returned to the lab.
At SCOPE: Tasso is at booth #432
eCOA/ePRO platform provider uMotif and MoCA Cognition, creators of the leading test for early cognitive impairment detection, are collaborating to make it easier to capture cognitive function and eCOA/ePRO data for CNS research. The MoCA Test helps clinicians and researchers rapidly scan multiple cognitive domains and detect impairment. It is the preferred screening test, used in over 200 languages and dialects, and is now available as a tablet app version and for videoconference administration. The standard MoCA test is administered to patients and can be uploaded into the uMotif platform for central rating and review. MoCA’s new XpressO test is a self-administered, digital cognitive pre-screening tool that efficiently distinguishes between populations of subjective vs. objective cognitive impairment. XpressO gives sponsors and CROs an advanced approach that provides an indicative score on the standard MoCA, and can be used by patients for fast, easy and scalable study pre-screening. Deployed together, the standard MoCA and XpressO enable the capture of a full set of eCOA/ePRO data for screening alongside the full cognitive test, which reduces screen fail rates and increases study speed.
At SCOPE: uMotif is at booth #731
Lokavant has announced PRIZM Clinical Data Hub (CDH), the industry’s source-agnostic clinical data hub to aid decision-making and improve trial performance with predictive analytics. PRIZM CDH acts as a single source of truth by ingesting data from all systems used in a clinical trial (i.e., CTMS, EDC, eCOA, RTSM, eTMF, Safety, etc.). The solution standardizes data in a central platform, enabling study visibility and driving meaningful improvements in study forecasting, study launch, study oversight, participant enrollment and medical monitoring. Lokavant’s PRIZM CDH acts as the central data depot for study teams by ingesting data from any source and automatically standardizing it to be used in predictive models. It doesn’t matter if the data comes from Medidata CTMS, Veeva eTMF, or from an internal system. All trial data is harmonized in PRIZM which fuels Lokavant’s platform to provide a centralized view of trial performance in real time. PRIZM CDH enables Lokavant’s platform to provide customers automated reporting and critical early-warning signals when a trial is veering off-track as compared to similar benchmarked studies so companies can course correct.
At SCOPE: Lokavant is at booth 321
Today, Revvity’s software and informatics division, Revvity Signals, unveils the Signals Clinical solution, a software-as-a-service (SaaS), end-to-end clinical data science platform designed to centralize all clinical trial data, providing fast, actionable insights for quicker clinical decisions and accelerated market delivery of therapeutics. This state-of-the-art solution, when integrated with enterprise-class Spotfire visual analytics, has the potential to redefine how the pharmaceutical, biotechnology, and contract research industries approach clinical trial data. Signals Clinical centralizes all clinical development data in one location and enables self-service access to clinical trial data, providing users with a complete picture of patient safety, treatment efficacy, and trial progress. Signals Clinical, when combined with Spotfire, not only streamlines the data preparation process but also enhances the delivery of strategic analyses, such as safety, efficacy, and cross-study analysis. By reducing the time and resources spent on manual data handling, Signals Clinical allows organizations to focus on delivering critical clinical trial insights and fostering cross-functional collaboration. Championing FAIR principles, the platform streamlines data preparation, reducing effort and maximizing value. Queries can be documented and referenced by study managers, enhancing collaboration and boosting overall team efficiency for clinical researchers.
At SCOPE: Revvity is at booth 236
ObvioHealth and Oracle Life Sciences announced late last week that they are expanding their partnership globally following the results of a year-long, successful effort launching trials in Asia Pacific. The collaboration will enable the efficient capture, integration, and analysis of multi-source clinical trial health data anywhere in the world—from participants, clinicians, devices, and labs. The expanded partnership coincides with the release of ObvioGo 2.0, the next generation of ObvioHealth’s digital clinical trial platform and mobile app. The new product includes a code-free study design platform with enhanced multi-lingual functionalities, enabling the translation and validation of eCOA and study app screens into any left-to-right language. eCOA data from the ObvioGo platform streams in real time into Oracle’s Clinical One solution, making remote participant and site-based clinical assessments immediately available for monitoring.
At SCOPE: ObvioHealth is at booth #936
At SCOPE: Oracle Life Sciences is at booth #601
Principal IRB announced a name change today at SCOPE. Now Univo IRB, the company is a next generation institutional review board (IRB) recently acquired by QHP Capital, an investment manager exclusively focused on building and supporting tech-enabled life sciences and pharma services companies. Univo IRB is focused on full-scale IRB services, bringing decades of IRB and clinical operations experience to support today’s clinical trials. Univo IRB plans to bring the voice of patients closer to research by creating an agile and efficient IRB review experience. This experience can only be achieved by combining Univo’s highly proficient workforce consisting of IRB members and staff who have hands-on research experience and industry-first technologies that are purpose-built for today’s complex trials. Univo IRB maintains accreditation through the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which consists of a federally regulated IRB committee charged with protecting the rights and welfare of people in research.
At SCOPE: Univo IRB is at booth #230
Earlier today Saama announced a newly expanded, multi-year agreement with global biopharmaceutical leader Pfizer to help expedite clinical research. The agreement represents the expansion of a strategic relationship that began in 2020 when Saama and Pfizer entered into a partnership to automate Pfizer’s data review processes with artificial intelligence (AI). The result of that initial collaboration was Smart Data Quality (SDQ), which significantly cut down the time to database lock. With this new agreement, Pfizer will continue to scale SDQ to help streamline and accelerate its data review processes across its broader portfolio of global studies. Not limited to SDQ, the new agreement expands the existing relationship to help Pfizer to accelerate regulatory submissions across its portfolio using Saama’s new advanced Biometrics Research and Analysis Information Network. Pfizer will now have the potential to reduce regulatory submission timelines across its global portfolio, as this next-generation solution streamlines statistical programming and biostatistics workflows, digitizes study specifications, and generates submission-ready tables, listings, and figures (TLF) artifacts. It will also set the stage for continuing automation and innovation to further accelerate future trial submissions.
At SCOPE: Saama is at booth 813
Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for digital therapeutics (DTx), has successfully completed a decentralized trial for the Sana Device. Sana has submitted the trial data for Breakthrough Device Designation consideration from the U.S. Food and Drug Administration (FDA) for its wearable, virtual-reality-style mask that uses audiovisual stimulation to reduce symptoms of post-traumatic stress disorder (PTSD). More than 45 patients were recruited from a Veteran’s hospital participated in the 28-day study. Curavit exceeded Sana’s expectations for participant retention with a 76% retention rate and managed all aspects of participation with remote-based clinical research coordinators (CRCs), a remote-based principal investigator, and fit-for-purpose technology platform including ePROs, eCOA, telehealth, device training, and randomization. Curavit CRCs captured participant experience with the Sana Device using industry-standard PHQ-9 survey and the Columbia Suicide Severity Risk Scale (C-SSRS) to capture levels of depression – all done remotely using electronic patient-reported outcomes assessments.
At SCOPE: Curavit Clinical Research is at booth 832
Advarra has announced new single sign-on (SSO) technology for clinical trial sites to reduce friction, increase security and free time to focus on patients. The capabilities empower site staff to use their own site-sanctioned credentials to access key systems including sponsor-provided technology. An industry-first, Advarra SSO delivers a sought-after process simplification crucial to sites, especially as the number of trial technologies continues to grow. Advarra’s SSO capability also eliminates endless password juggling and swiveling back and forth between applications – even screens – to save time and free staff to focus on patient care.
At SCOPE: Advarra is at booth 1001
Medable has announced results from a new research project with Duke University Department of Population Health Sciences’ Bioethics and Stakeholder (BASE) Lab on the acceptability of enhanced electronic informed consent (eIC) in clinical trials. The pilot study compared participant comprehension and usability, satisfaction, and preference of enhanced eIC versus text-only eIC, specifically exploring the use of interactive videos, graphics, calendars, and other tools to augment text in an eIC form. The study looked at 24 patients who reviewed an eIC in a mock study for an investigative medicine to treat hypertension: half reviewed the text-only eIC first followed by the enhanced eIC, and the other half did the opposite. The study population was diverse in gender, age, race, and geographic location. Nearly three-fourths (71%) of the study participants said the enhanced eIC was more informative and indicated that the digital elements were personable and made them feel more informed, engaged, comfortable, and prepared to participate in clinical research.
At SCOPE: Medable is at booth 621