Unified products and services…

The release unifies Formedix solutions and gives admin users access to global user management controls.

Highlights of the latest Formedix release

• Enterprise User Management: Access Origin Study Modeller, Origin Submission Modeller and Formedix On with one set of user credentials. Unified user accounts can then be managed online via Formedix On.

• Integration Management: Control 3rd party EDC and data mapping plugins globally for all users in your account. Roll out updates to plugins and add new plugins remotely without the need to reinstall or revalidate.

• Enhanced Formations Management: A single Formations account for all products.

“Rolling out this exciting functionality across all of our products and services is really positive for Formedix and our clients. It’s a huge step towards our vision to be the pre-eminent supplier of cloud based clinical trial automation solutions,” said Mark Wheeldon, CEO at Formedix. “We continue to grow our collection of on demand solutions and enhance our data acquisition and dataset design tools with a focus on reducing the time and cost of clinical trials, increasing the quality of trial submission deliverables, and reducing the burden of regulatory compliance. At a time where submission regulations are rapidly changing, our unique solutions are doing exactly that.”

Existing users

For existing users, the upgrade is free and the changes will further enhance their experience. New and existing users will have access to all Formedix clinical trial automation software, services and training without the restrictions of named user licences.

• Origin Study Modeller : A unique data acquisition design tool allowing you to design how your study will look upfront. Functionality includes eCRF design specifications, visualizations and automated build of 7 EDC systems, ability to manage standards and reuse trial assets.
• Origin Submission Modeller: A dataset design tool allowing you to design datasets for submission to global regulatory authorities. Users can manage dataset design libraries, design dataset specifications upfront and map target datasets from source datasets.
• Formedix On: A collection of easily accessible online solutions and CDISC standards training.On demand solutions are designed to streamline the clinical trial submission process, ensuring submission deliverables are of high quality and are regulatory compliant. These include conversion of EDC datasets to SDTM datasets, conversion of SAS XPT to Define-XML, conversion of Define-XML 1.0 files to Define-XML 2.0, and free tools to validate your studies against global standards.eLearning courses focusing on CDISC standards can be purchased and undertaken online, allowing users to learn at their own pace. Courses include CDISC Define-XML, ODM (Operational Data Model), SDTM (Standardized Data Tabulation Model), SDTM Implementation Guide and CDASH (Clinical Data Acquisition Standards Harmonization).