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In order to avoid a constrained growth model, an R&D focused organization needs to empower its business stakeholders with cross-functional insight and portfolio-level information management strategy.
Prospective solutions should allow necessary roll-down and roll-up flexibilities in identifying potential indicators of change (e.g. risk and/or opportunities) and its impact, while taking decisions with confidence.
To mobilize such transformative business strategy, the technology enablers must ensure that their current clinical development processes, existing investments, partnerships, and corporate strategies do not get impacted. Therefore, the evolution of AN INTEGRATED CLINICAL DATA MANAGEMENT PLATFORM begins with bringing in or (rather) aligning existing and new data sources into a single-source of truth (Data Repository); wherein they can all have common characterization, identity, accessibility, predictable movement in reference to other. Above all, a governance layer that establishes complete control over the clinical data assets as they move forward in the clinical development processes.
Overall, we understand that there has been a huge gap, a rather siloed approach, between the clinical data capture,clinical data management and the processes utilized in deriving actionable insight from the clinical data. Clinical data capture systems have improved a lot over time, and so did the increase in the sources and varieties of clinical data, but, clinical data management, the analysis & reporting processes still suffer – this demands integration, aggregation, and harmonization of clinical data with the integrated tools to achieve maximum downstream benefits within Analytics, Reporting, and Mining of critical Clinical & Operational Data horizontally across the silos.
Single-source-of-truth clinical data repository with its ability to deliver timely access to an aggregated form of clinical data across the historical studies, and real-word clinical data, have paved ways to detect diseases at earlier stages when they can be treated more effectively and in a timely manner. They also help us to manage specific patient and population health; and detect health care fraud or clinical risks more quickly and efficiently.
Development of medicines through agreement on evidence standards, including extrapolation of available clinical data for predicting drug behavior and encouraging a multi-arm, multi-company approach to reduce patients in clinical trials are some outcomes of global clinical trials. This requires drug manufacturers to choose an integrated clinical data management solution that allows integrated capabilities across the life cycle of clinical data from source to submission.
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.”