Metadata Repository (MDR)

Streamline the lifecycle of clinical metadata, from creation to submission.

Achieve superior data quality and compliance in your clinical trials

MDR ensures regulatory adherence, improves traceability, transparency, and integrates seamlessly with existing systems to support efficient workflows and decision-making in clinical trials.

Enhance Clinical Trial Efficiency with MDR

Streamline metadata management, boost operational accuracy, and expedite your clinical processes for better outcomes.

BENEFITS

Streamlined Clinical Development

Achieve seamless instream metadata flow from source to submission, enhancing efficiency and enabling faster time to market.

Change Management

Leverage change control enforced for streamlined operations, including creating, editing, cloning, and archiving metadata.

Effective Metadata Management

Ensure efficient handling of both development and production-ready metadata assets, leading to better organization and accessibility.

Customizable to Your Needs

Adapt the MDR solution to meet unique customer requirements, offering flexibility and scalability and ensuring higher ROI.

Enhanced Data Quality

Track and analyze metadata changes effectively, ensuring high data quality and providing deeper insights.

Secure Centralized Storage

Maintain secure, version-controlled storage for data, documents, and templates, minimizing the risk of data loss or unauthorized access.

Automation and Reporting

Advanced automation capabilities and robust reporting streamline processes and reduce manual effort.

Search

Apply context sensitive search that allows user to search metadata assets and browse them in the user interface.

FEATURES

Why choose CTOS?

CTOS is a flexible platform designed to help complex clinical trials—traditional site-based, decentralized, hybrid, or 100% virtual. Using advanced automation, CTOS brings greater visibility to your trial data at both the study and portfolio levels.

Metadata Management

Create, manage, compare, and share metadata with robust governance and version control.

Approval Workflows

Implement structured approval processes with compliance and quality checks.

Data Mapping Tool

Standardize data types (SDTM, ADaM, OMOP) with a user-friendly low code/no code tool.

Submission Packages

Generate Define.xml and comprehensive submission packages.

Repository Integration

Centralize storage for documents, metadata, and data, integrated with MaxisIT’s Data Management Workbench (DMW) and Statistical Computing Environment (SCE) products.

Cloud Solution

Supports eCRF Specifications for EDCs like Medidata Rave, Oracle InForm, Veeva, Medrio, Parexel, Open Clinica, etc.

Visual Comparison Tools

Facilitates easy comparison of multiple versions of any metadata asset – eCRF, CDISC Metadata, Database/Mapping Specification, etc.

Pre-Validated Systems

Ensures smooth implementation with support for customer validation, user acceptance testing (UAT), and adoption.

See how our integrated Metadata Repository (MDR) solution can support your clinical data management needs.

Testimonials

  • Sergey Krymgold, Senior Director of Clinical Trials, Tools, and Technologies at Takeda Pharmaceuticals
  • Aarti Sanadi, Associate Director of Clinical Trials, Tools, and Technologies at Takeda Pharmaceuticals
  • Data Analytics Innovations: Insights from Jayasree Ivaturi, Associate Director at MaxisIT
  • Randall Paulk, Senior Manager of Data Management Clinical Systems at J&J Vision Care
  • Greeshma Mundayat, Clinical Solutions Owner at MaxisIT

Related Resources

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