ThoughtSphere, a clinical technology solution provider, unveiled solution enhancements to two of its core products, ClinDAP and ClinACT, in the areas of product function, usability, and security at this week’s Clinical Trial Innovation Summit (April 24th – 25th) in Boston, MA.
The main developments include composite medical triggers on key domains–Lab, Vitals and End points; composite operational triggers associated with risk plan and actions thus enabling the study team to define their own study specific risk triggers with appropriate thresholds, this helps in adapting to unique study specific needs ; absolute value and non-relative triggers for dynamism in using clinical and non-clinical data for RBM; additional functionality to support DMC and medical monitors allowing both blinded and un-blinded users in the system; notification enhancements for central monitoring to speed communication, query resolution, and issue management between CRA and site; security enhancements; and framework enhancements to support ad-hoc reporting that will provide flexibility on creating graphs and reports using configuration rather than code changes.
Sudeep Pattnaik, founder and CEO of ThoughtSphere explained: “Because ClinACT and ClinDAP are cloud-based solutions, rolling out product enhancements for our users is simple.” He added: “These new features reflect input from our clients as well as our own ideas and innovations about how we can continually streamline and improve users’ ability to collect, manage, and analyze clinical data.”
ClinDAP is a source-system agnostic data aggregation platform that allows users to manage data from any clinical, operational, or other data source of interest. ClinDAP is built on a clinical data lake, which offers advantages over the more old-fashioned approaches to data storage and management, such as connectors and data warehouses. It gives users complete freedom from complex manual data aggregation and allows them to instead focus on interpreting data and applying their findings. It also has an easy-to-use analytics tool that enables user to easily visualize outliers and trends.
ClinACT is a complete RBM solution with two complementary modules. Users can just leverage the Analytics module or unlock full functionality with the integrated Risk module. ClinACT uses ThougthSphere’s innovative approach to data aggregation to drive more effective clinical research decision-making processes for users, and to make it easier for users to deploy both on-site and decentralized risk monitoring approaches, as per the recent recommendations of key regulatory agencies.
ThoughtSphere’s strategic advisor, Andy Lawton, spoke at the conference on April 25th around ‘The Critical Role of Issue Management (Systems) in Clinical Research.’ He discussed the importance of having a robust Issue Management (IM) process, as well as the problems that arise if you fail to do so. He provided detailed tips on how to optimize and improve an IM process and ensure it is effectively integrated with your CTMS, Site Management System, and RBM solution. On April 26th, he joined ThoughtSphere Technology Evangelist, David Lacagnina to co-present “Bridging the Clinical Structure Gap for Holistic RBM: How Fully Integrated Data Empowers Risk Management”. This session focused on data integration and regulatory guidance from FDA and EMA on RBM addressing the siloed nature of the sponsor organization structure that is all too often also represented in the data availability. Data integration brings to life risks that are not apparent when you examine the data from one source alone, examples shown will include eCRF and audit trail, CTMS, Drug Safety database, etc.
The Clinical Trial Innovation Summit brings together leaders in pharma, biotech, and academia to discuss news, trends, and best practices in effective clinical trial management and vendor oversight. This year’s focus areas included data integration, management of existing data sources, quality (QbD) in trial conduct, risk-based monitoring, and clinical auditing, all of which are areas that ThoughtSphere’s solutions can directly impact and improve.
For more information about ThoughtSphere or ClinDAP, visit http://www.thoughtsphere.com
For more information about the enhancements to ClinDAP and ClinACT or Mr. Lawton’s presentation, contact firstname.lastname@example.org.
For more information about the Clinical Trial Innovation Summit, visit http://www.clinicaltrialsummit.com/.
Founded by clinical information and technology industry experts with over 30 years of experience from the leading global CRO and eClinical providers, ThoughtSphere’s mission is to streamline and empower the clinical trials process by eliminating the two biggest challenges–integration of disparate clinical and operational data and making it accessible for use with existing tools for analytics and visualization. With this innovative platform, biopharma, medical device sponsors and CROs can reduce and optimize clinical development costs, aggregate operational and clinical data to enhance efficiency and effectiveness in the clinical trial processes and gain near real-time actionable insights. The product suite includes ClinDAP, the source-system agnostic next-generation data integration platform; ClinACT, the interactive visualization and analytics platform that enables RBM and CRO Quality Oversight; and SPACE, the integrated site budgeting, payments and contracting solution. At ThoughtSphere, we believe we can deliver on the promise of big data to drive health innovation. For more information, visit www.thoughtsphere.com
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