Managing Standards

CDISC Standards File
Data quality and regulatory compliance are two of the biggest issues in our industry

We need to improve the consistency and reliability of our data, and ensure it meets the various regulatory requirements to facilitate a hassle free submission.

The key is managing your metadata. Designing and refining a set of standard forms, edit checks, datasets, mappings, terminologies and other assets that can be used from study to study. When assets are standardized across the clinical lifecycle, you can be sure data collection is consistent, valid and efficiently pushed into a standardized submission.

Formedix has worked with leading life science organizations to develop standards management functionality optimized for clinical trials, to deliver trials as quickly and efficiently as possible.

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Drivers for Standardization

Many aspects of the clinical lifecycle are improved by proper management of metadata inside a central metadata repository.

Data quality

Improving data quality is the key driver for implementing internal standards and a metadata management system.

  • Define all your data up front
  • Ensure consistency across studies
  • Standardize mappings between different parts of the clinical lifecycle
  • Drive study designs from standards
  • Perform compliance checks to ensure adherence to standards.
Regulatory compliance

A centralized metadata repository supporting the latest industry standards such as CDISC SDTM, ADaM and Define-XML ensures you can meet the requirements of regulators such as the FDA, PMDA and EMA.

Removing information silos

Silos reduce visibility of metadata, making it hard to standardize and reuse. Bringing all your assets into a centralized repository ensures information is easily accessible and in a consistent format, facilitating standardization and reuse and enabling you to make the right decisions.

Governance

Managing metadata in a centralized system allows consistent change control and governance processes.

Single source of truth

A centralized metadata repository gives a single location to find your metadata assets. No more trying to remember where something is kept, or whether there's a newer version somewhere else.

Reuse of metadata

Study setup time can be dramatically reduced by pulling from standards. This leads to greater process efficiencies as the content has been already tested and validated, leading to less likelihood of mistakes and consistent mapping to downstream systems.

 70% content reuse across clinical trials

70% content reuse
across clinical trials

 

 Study setup time for EDC reduced by 68%

 68% reduction in
study setup time for EDC

Integrations

Support for a number of different file formats and standards allows integration with a wide variety of other systems and processes.

Our techincal team can add support for additional systems and internal processes on request. This allows organization-specific metadata, and visualization of information in ways already familiar to your teams.

Building Studies from Standards

Building a study from a set of standards is extremely simple and streamlines the clinical lifecycle while increasing data quality.

Build studies from standards process diagram
  • Choose your forms and related datasets directly from your standards - no need to create them manually
  • Edit checks, mappings and other related metadata are brought in automatically from your standards so you know they're correct
  • Add protocol-specific information such as the visit schedule, custom edit checks, or custom mappings
  • Visualize how the CRFs will look in your preferred EDC system to ensure they are correct
  • Once you're done, compliance checking shows any deviations from your standards.

This all happens within a governance workflow ensuring you have control over your study designs.

Once the study design is complete it can be exported to your choice of EDC system. No manual build time is required, and you know the study database is exactly as you designed. You're also ready to generate interim downstream datasets once the data starts coming in, as the mappings are part of the study design. No need to code your data conversions for each study.

Formedix On logo

Formedix On is a powerful platform designed to accelerate your clinical trials and drive data quality through the standardization and reuse of metadata. It is based on CDISC standards, facilitating regulatory compliance with the FDA, PMDA, EMA and other regulators.

With Formedix On you can:

Support for industry standards such as SDTM, ADaM, SEND, Define-XML, Analysis Results Metadata, Dataset-XML and ODM comes built in. In fact, Formedix have been active members of CDISC since 2001 and our products are CDISC certified.

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