News

Clinical Metadata features

Monday 11 March 2019

Clinical Metadata - version control

Clinical Metadata automatically version controls metadata artefacts creating an audit trail showing when each change was implemented and which user was responsible, this helps users understand the evolution of metadata within a trial.

The system allows users to roll-back to previous versions of metadata ensuring that vital information can be restored if required.

If you would like to arrange a demo, to learn more about Clinical Metadata's new features, or to setup a sandbox version of Clinical Metadata, please contact us at: info@clinicalmetadata.com.


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Clinical Metadata - End-to-end clinical trial metadata management

Monday 18 February 2019

Clinical Metadata 2.0

ClinicalMetadata.com provides an end-to-end metadata management solution, including SDTM, ADaM and Analysis Results Metadata. It generates SAS code fragments and submission deliverables, automating repetitive programming tasks, accelerating and simplifying the study reporting process.

Some of its key features include:

  1. End-to-end metadata management within a trial.
  2. Standards governance.
  3. Metadata driven SAS code generation.
  4. Creation of Define.xml.
  5. Metadata visualizations.

If you would like to arrange a demo, to learn more about Clinical Metadata's new features, or to setup a sandbox version of Clinical Metadata, please contact us at: info@clinicalmetadata.com.


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Clinical Metadata - New release now available

Monday 3 September 2018

Clinical Metadata 2.0

Clinical Metadata 2.0 is now available. The new version adds support for Analysis Results Metadata, version control and enhanced standards management functionality.

We are now starting our first sandbox trials with new clients, enabling them to spend a month evaluating the benefits of our system.

Over the coming weeks we will be publishing a series of blog posts outlining several different use cases for Clinical Metadata and explaining how it can help you eliminate repetitive data entry, manage your standards and leverage the full potential of your metadata.


If you would like to arrange a demo, to learn more about Clinical Metadata's new features, or to setup a sandbox version of Clinical Metadata, please contact us at: info@clinicalmetadata.com.


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Clinical Metadata - New version

Tuesday 17 April 2018

New release coming May 2018

In the last six months Clinical Metadata has been used successfully on a live Phase III trial. Based on the feedback we received from this and from our presentation at the PhUSE conference in Edinburgh we have been working on a new version.

The new release will be available in May 2018.

Enhancements include:

  • Analysis Results Metadata support
  • Enhanced standards management
  • Additional SAS code generation
  • New visualisations
  • Define.xml import

  • If you would like to arrange a demo, or to learn more about Clinical Metadata's new features, please contact us at: info@clinicalmetadata.com.


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    PhUSE annual conference Edinburgh

    Friday 20 October 2017

    PhUSE conference papers now available

    The annual PhUSE conference in Edinburgh took place between the 8th and 11th of October. The event featured a record number of attendees and many great posters and presentations

    We thoroughly enjoyed discussing the latest developments in CDISC and clinical trial reporting with the other delegates and presenting our metadata repository.

    The conference papers are now available on Lex Jansen's website . You can find our paper, Clinical Metadata: Metadata management with a CDISC mindset there too.

    We look forward to seeing everyone at the conference again next year and updating everyone on the progress we have made with our MDR.


    Learn more about Clinical Metadata's features here.

    If you would like to arrange a demo, or to learn more about Clinical Metadata contact us at: info@clinicalmetadata.com.


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    CDISC conformance checks

    Saturday 07 October 2017

    How a clinical metadata repository can help the pharmaceutical industry achieve CDISC compliance.

    Ensuring that clinical trial data and Define.xml satisfy the SDTM and ADaM CDISC conformance rules is a key part of achieving CDISC compliance. Traditionally the biopharmaceutical have relied on external tools to assess the compliance of their data. These external validators have been widely adopted, both by industry and by regulatory authorities, and they will continue to be an important part of the conformance testing process, however one issue with such tools is that they only detect compliance issues late in the process. Consider the following compliance testing system based on an external validator:


    CDISC compliance flowchart

    Each time a CDISC compliance issue is detected by the external validator it would be necessary to modify the metadata and begin the process again. This could be time consuming for large clinical trials, and additionally could result in unnecessary rework.

    Our clinical metadata repository is designed to steer the user towards CDISC compliance. One way it achieves this is by detecting CDISC compliance issues at the point of data entry.

    Clinical Metadata input verification.

    In future posts we will be sharing more ways in which Clinical Metadata can help the pharmaceutical industry achieve CDISC compliance.


    Learn more about Clinical Metadata's features here.

    If you would like to arrange a one-to-one demo at the conference, contact us at: info@clinicalmetadata.com.


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    PhUSE Medatata management

    Friday 06 October 2017

    Metadata management with a CDISC mindset

    Clinical Metadata wil be presenting our metadata repository within the Standards Implementation stream of the PhUSE conference in Edinburgh.

    Read our abstract below or find it on the PhUSE wiki or on the SAS Community pages.

    Abstract

    Metadata is now an integral part of the clinical trial process. CDISC provides the framework for this metadata and Define.xml provides a way to share the final product. There is, however, no standard way to efficiently collect, manage and collaborate in the process of creating metadata.

    ClinicalMetadata.com provides an end-to-end metadata management solution, including CDASH, SDTM, ADaM and output metadata. It generates SAS code fragments and submission deliverables, automating repetitive programming tasks, accelerating and simplifying the development process.

    Clinical Metadata is built as a web-based single page application, using the latest technologies and practices, and is securely hosted in the Amazon Web Services cloud. Its visualisation tools present the user with a high-level metadata overview and allows them to drill down into individual metadata fragments. In-built standards management, traceability and impact analysis tools help users understand the relationships between each metadata element as well as encourage Agile and collaborative ways of working.


    Learn more about Clinical Metadata's features here.

    If you would like to arrange a one-to-one demo at the conference, contact us at: info@clinicalmetadata.com.


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    PhUSE conference Edinburgh

    Wednesday 04 October 2017

    Clinical Metadata at PhUSE

    We will be presenting our cloud based metadata repository at the PhUSE conference on Tuesday 10 October in Edinburgh.

    The presentation forms part of PhUSE's new Standards Implementation stream. During it CEO Andrew Ndikom CEO and CTO Liang Wang will show how Clinical Metadata can help the biopharmaceutical industry achieve CDISC compliance, manage your data standards and simplify your workflow.

    We will explain the advantages of transitioning to a cloud based metadata repository and show how our visualisation tools help users to understand the metadata flow end-to-end, while our SAS code generator facilitates the creation of SDTM and ADaM datasets.

    Learn more about Clinical Metadata's features here.

    If you would like to arrange a one-to-one demo at the conference, contact us at: info@clinicalmetadata.com.


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    News and events

    Tuesday 03 October 2017

    Introducing the News and Events page

    The News and Events page provides regular updates on Clinical Metadata's new features, upcoming releases and publications.

    It is also a place to find important industry related news released by CDISC , the FDA and others.

    We will use these pages to explain how our cloud based clinical metadata repository can help the biopharmaceutical industry implement CDISC and accelerate the study reporting process.

    You can also follow us on twitter and Linkedin to learn more about upcoming activity.

    If you would like to arrange a demo, or to learn more about Clinical Metadata contact us at: info@clinicalmetadata.com.


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