26 Nov 2020 Blog
Clinical Trial Oversight over Hybrid or Virtual Trials

Pharma companies face huge challenges with the variety and volume of data they receive from across their clinical trial portfolios. Core challenges faced in clinical trial management vary from study design optimization to targeted therapies to benefit-risk assessments to cost reduction. Then we have the need for increased access to a core primary asset or data, for the purposes of decision-making, predictive analysis, insight, and strategic planning. Multiple processes and data formats result from individual applications, structured along departmental and functional silos. Insights are insufficient to help anticipate future business opportunities proactively. Operating in a reactive manner and producing pre-defined visualizations is not enough. The need for digitizing the processes was pressing, but change was slow and sporadic.

In the initial days of the pandemic, on-site visits by trial participants stopped as most sites were busy treating COVID-19 patients and couldn’t spare any infrastructure for the conduct of clinical trials. Patients were also unable or unwilling to go to the sites. This has posed major challenges to the continuity of clinical trials, causing many of them to pause their studies. It wasn’t possible to enroll new patients while the enrolled trial participants were unable to fulfil on-site treatments schedules. With the increasing adoption of digitization, many trials moved to adopt virtual/hybrid processes, which enabled the trial participants to continue participating in a trial remotely. The industry quickly turned to patient-centric technologies like eCOA, ePRO, eConsent, Telemedicine, wearables etc. Thereafter, patients are able to effectively use the various cloud-based apps and tools on their phones to get assessed by physicians remotely and to continue their participation in the clinical trials.

The industry needs to ensure that these app-based, digital technologies are effectively integrated into their single-source-of-truth data hub for effective remote-patient-monitoring, remote-trials-monitoring and ultimately ensure that they get to maintain total oversight on their virtual trials, alongside of trials which are partially virtual (in other words, hybrid) and the trials which are still traditional. Now, all these hybrid/virtual trial set ups need the able support of a technology platform not just to enable remote monitoring, but also to provide sponsors/CROs to stay connected and informed in a virtual manner. The importance of picking the right digital tools to achieve desired outcomes cannot be stressed enough, at this stage.

The data collected from patients, whether reported by them or captured through a wearable technology – can be easily integrated by MaxisIT®’s CTOS. As an evangelist in this field, MaxisIT® addresses all these issues and more with a complete end-to-end integrated solution for companies across the Life Sciences / Healthcare Enterprises.  Our solution delivers on two critical challenges faced by the business: 

  • Lack of access to Integrated Data: Acquisition, cleansing, virtualization, harmonization, standardization, validation, and management of multiple types of structured and unstructured data and metadata.
  • Unmet need for Analytics and Reporting:  An analytical environment available for “power users” is used to conduct predictive and exploratory analytics for data Sciences purposes.

A resolution to these challenges lies in adopting an integrated clinical data management platform like MaxisIT®’s ONE Integrated Clinical Development Platform for the biopharmaceutical industry –  which acts as a centralized Command Centre for Remote Clinical Data Review and end-to-end Clinical Data Management. Integrates and interoperates across all eClinical Systems and Virtual Patient Data sources via a secure, cloud-based offering – shifting focus to data management as opposed to data integration. As the industry’s most comprehensive, integrated, automated, and intelligent Data Management Platform, it supercharges data flow across data quality management, remote data review, and study data oversight, readily integrates clinical data from virtual/hybrid sources.

The platform integrates data from different applications or systems at different levels, to manage virtual/hybrid trials, by aggregating all the clinical data in real time, across the data silos. It offers timely access to authoritative, standardized, integrated data and enables risk mitigation with efficient trial oversight via remote monitoring. It makes data quality management possible with real-time controls and statistical computing with assured adherence to timelines and compliance requirements. The platform adopts a command centre approach to truly empowers clinical data management and data review teams to maintain quality and integrity of clinical trials’ patient data by offering seamless interoperable and metadata-driven data, providing the following benefits:

  • The system offers scalable, data-agnostic access and control over to sources – easily integrates and unifies across 16 different eClinical systems (e.g. EDCs, LABs, IRTs, ePROs, Safety systems, CTMSs etc.), top 8 CROs systems, and 50 plus wearable APIs.
  • Fail-proof, and purpose-built clinical data management platform that delivers a true single-source-of-truth clinical data hub across the types, sizes, phases, and modes of clinical trials across the end-to-end clinical data value chain.
  • AI-enabled, API-driven, modular approach delivers value through automation, interaction, and reasoning for intelligent, actionable, and guided reviews for timely and informed decision-making.
  • Real-time, on-demand, and role-based data & dashboard access with intuitive visualizations for efficient monitoring and reviews, and early detection of issues, with self-service offering huge time and cost savings
  • Enhances meaningful focus between teams with built-in, role-based, and collaborative workflows at each functional stages of data management, review, and assessment with traceability for regulatory compliance
  • Built for clinical data management by clinical data management professionals for meaningful and in-time data review to ensure data quality, patient safety, protocol compliance, and on time reporting & submission.

MaxisIT®’s Integrated Clinical Development Platform for biopharmaceutical industry adopts a transformational strategy to detect the leading indicators of change in clinical trial management and empowers key decision-makers to derive maximum value from the data collected across their portfolios.  Technologically advanced tools like MaxisIT®’s CTOS have been helping the healthcare industry to enjoy complete oversight across the results of their hybrid/virtual trials. They gain total control over their clinical trial portfolio data to take proactive action, improve the outcomes on their clinical studies and to derive better business outcomes.

About MaxisIT

At MaxisIT, we clearly understand strategic priorities within clinical R&D, and we can resonate that well with our similar experiences of implementing solutions for improving Clinical Development Portfolio via an integrated platform-based approach; which delivers timely access to study specific as well as standardized and aggregated clinical trial operations as well as patient data, allows efficient trial oversight via remote monitoring, statistically assessed controls, data quality management, clinical reviews, and statistical computing. Moreover, it provides capabilities for planned vs. actual trending, optimization, as well as for fraud detection and risk-based monitoring. MaxisIT’s Integrated Technology Platform is a purpose-built solution, which helps Pharmaceutical & Life sciences industry by “Empowering Business Stakeholders with Integrated Computing, and Self-service Dashboards in the strategically externalized enterprise environment with major focus on the core clinical operations data as well as clinical information assets; which allows improved control over externalized, CROs and partners driven, clinical ecosystem; and enable in-time decision support, continuous monitoring over regulatory compliance, and greater operational efficiency at a measurable rate”.

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