7 Feb 2018 Blog
Rising above the data silos

How an Integrated Clinical Development Platform Helped a Client Tear Down Clinical Data Silos and Improved Decision-Making.

How an Integrated Clinical Development Platform Helped a Client Tear Down Clinical Data Silos and Improved Decision-Making.

The Challenge – Riddled with mélange of data and challenges in standardization which hamstrung 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 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 data seamlessly and provide a unified view of the 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 data integrity and quality.
  • Simplified the management (update, version control etc.) of metadata, standards and specs
  • Facilitated improved electronic metadata exchange
  • Enabled automated validation and conformance checking of 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 data across multiple studies and across pipelines thus providing a single source of truth
  • Maximized the value of data assets by making the 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 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 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 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.

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