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There has been a collective realization throughout the industry that the key data management processes must show efficiency, continuous compliance, scalability, sustainability and measurable productivity gains that, over time, will transform the research and development processes used to develop new drugs.
Industry leaders are addressing this problem by delivering solutions that can address various needs ranging from study design to data integration to clinical process optimization to targeted therapies to benefit-risks assessments to cost reduction.
Primarily clinical data management solutions empowers the ecosystem with decision making abilities backed by precise, accurate and timely insights. Some best practices culminate to build an integrated clinical data management solution that works for current processes and the future of clinical trials.
Integrated Data Management Platform: There is no single software to capture all kinds of clinical data. During clinical trials, practitioners use multiple software, devices and apparatus to capture data. Though EDCs are fast catching up, globally, some local circumstances and low capital-intensive projects still rely on paper-based case reports and ePROs. Some data is also in the form of X-ray, scans which is different format altogether. Therefore, industry needs a platform that allows integration across these diverse sources of data, and further provides all of the data in a single clinical data repository.
Real-time Data processing and insights: For a long time, information churned out of large data sets have been processed in isolation causing complexities. But today, we see a pressing need to use real-time analytics with integrated data from devices, health systems, payers, patients, providers and other systems and participants to deliver services.
Metadata driven process: To deal with entropy in clinical data, efficient CDMs use metadata. Metadata facilitates information flow, improves retrievals, helps in discovery and provides context by applying metadata principles to information. It establishes some of the most lacking comforts for a data scientist trying to arrive at meaningful insights. Some of those benefits include user friendliness with a simple and intuitive interface.
Reporting Tools: Seldom clinical data management solutions are integrated with reporting tools that can configure, execute, and review reports with built-in analytical algorithms in support of analyzing the data quality, clinical significance, operational performance, as well as reviewing genetics and proteomics data.
Risk Based Monitoring & Assessment: Solution that helps mitigate risk by allowing organizations to focus on critical study parameters. A robust risk monitoring & assessment needs to be empowered with analytical and reporting capabilities, third-party integrations with open APIs, workflow engine and a knowledge base.
Regulatory and Compliance: An integrated Data Management solution should be configurable to support different types of trial data, trial protocols, results and subject-level data. This configurability comes with an inherent need of maintaining regulatory compliance & audit traceability. Such solution should be robust enough to configure study specific needs and translate data to meet the regulatory and compliance standards both globally and locally.
The increasing volume, variety in data and the velocity at which clinical data is being produced, a recommended solution needs to be agile and robust to respond to such versatile dynamism.
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 data, allows efficient 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 purpose-built solution, which helps Pharmaceutical & Life sciences industry by “Empowering Business Stakeholders with Integrated Computing, and Self-service Analytics 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”.
23 Jul 2019