How an Integrated Clinical Development Platform Helped a Client Tear Down Clinical Data Silos and Improve Decision-Making.
The Challenge – Faced with a mélange of clinical data and challenges in standardization which hamstring their decision-making capabilities, our client decided to implement an integrated platform-based strategy that would help them to
- Ingest data from diversified sources
- Establish a single-source-of-truth
- Enable clinical metadata repository-based standards compliance and,
- Establish a controlled statistical computing environment on top – all seamlessly interoperable and metadata-driven.
The Objective – The mandate was simple. Enable teams to access clinical data across a clinical portfolio seamlessly and provide a unified view of the clinical data to deliver regulatory standard deliverables on time and further perform exploratory analytics.
The Solution – An Integrated clinical data management platform which delivered three business critical solutions.
Metadata Repository (MDR)
- Achieved metadata re-use and consistency of definition across the clinical data collection – analysis lifecycle
- Minimized duplication of work and improved clinical data integrity and quality.
- Simplified the management (update, version control etc.) of metadata, standards and specs
- Facilitated improved electronic clinical metadata exchange
- Enabled automated validation and conformance checking of clinical data
- Enabled automated data conversion (from one standard to another)
- Enabled impact analysis and change management across metadata standard assets
Clinical Data Repository (CDR)
- Efficiently integrated clinical data across multiple studies and across pipelines thus providing a single source of truth
- Maximized the value of clinical data assets by making the clinical data accessible in a consumable (neutral) and quality conformed format to stakeholders across R&D
- Improved decision-making by ensuring reports are produced promptly and accurately, and enable prompt responses to regulators and other departments within an organization
- Stored clincial data in a structured and secure manner to support reproducibility and an improved ability to incorporate data into analyses.
Statistical Computing Environment (SCE)
- Streamlined processes for workflow, version control, traceability, access management, audit trails that eliminated manual steps involved in compliance with operating procedures
- Improved team collaboration through better organization and navigation of project artifacts across regulatory reporting process
- Facilitated full traceability and improved regulatory compliance and inspection readiness
The Outcome – While the first feature laid the foundation for scalable analytics development and testing, the second and third feature provided the overarching structure for sharing knowledge and best practices. Most importantly, the platform provided a single unified view of all clinical data which allowed teams to finally speak the same language; something the company found immense value in.
Read the full case study here
About MaxisIT – MaxisIT® provides ONE Integrated Clinical Development Platform for the biopharmaceutical industry – MDR, CDR and SCE combined in one scalable, integrated, cloud platform. The platform includes self-service data preparation and analytics products which are regulatory compliant, validated and delivered through alternate models viz. Enterprise SaaS, On-premise deployment, or as a Hybrid software-enabled service.
At MaxisIT, we believe that complex data analysis can produce simple yet powerful insights.
MaxisIT’s Clinical Trial Oversight System (CTOS) is a purpose-built command center designed to manage biopharma and life sciences clinical trials as mission-critical business processes. With its complete AI-enabled analytics platform, the CTOS enables “data-driven digital transformation” from data ingestion, processing, and analysis to in-time clinical intelligence. Its real-time data ingestion, analytics, and visualization empower researchers to identify and address errors as they occur.
The CTOS elevates the value of data, improves efficiency, and empowers clinical stakeholders to seize new opportunities. The platform brings clinical operations and patient data together in a single, central data hub as a single-source-of-truth to help clinical operations, clinical data management, biostatistics, and clinical R&D portfolio management.
A complete self-service, AI-enabled analytics platform, the CTOS unifies trial data from disparate eClinical systems to support study planning, clinical data quality, clinical review, patient safety, clinical operations, CRO performance, risk-assessment, portfolio management, compliance, and submission.
From study setup to data ingestion, clinical trial stakeholders can manage clinical development processes with insight into the study conduct and take proactive actions to reduce costs, mitigate risks, and ensure compliance.
MaxisIT’s CTOS helps you maintain an ongoing health-check on your portfolio of clinical trials, using real-time data, analytics, and visualization to drive rigorous analysis of the entire dataset, allowing for proactive trial risk management.