New Additions to Datafarm's Regulatory Technology Solutions Meet Global eSubmissions Challenge

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A leading provider of Electronic Document Publishing solutions and Regulatory Submissions Services for the Life Sciences Industry, Datafarm is pleased to announce the launch of a new and extended set of modules that directly address the electronic regulatory submission challenges faced by life sciences companies worldwide. The addition of the NeES and Report Level Publishing module and enhancements to the eCTD and Paper modules in the S-Cubed® suite will now enable sponsor organizations to submit all types of submissions currently accepted by agencies around the world.

A leading provider of Electronic Document Publishing solutions and Regulatory Submissions Services for the Life Sciences Industry, Datafarm is pleased to announce the launch of a new and extended set of modules that directly address the electronic regulatory submission challenges faced by life sciences companies worldwide. The addition of the NeES and Report Level Publishing module and enhancements to the eCTD and Paper modules in the S-Cubed® suite will now enable sponsor organizations to submit all types of submissions currently accepted by agencies around the world.

The challenges facing regulatory operations teams continue to evolve and become increasingly complex. Many health authorities have announced their intent to migrate to a full electronic submission process, while others are still entrenched in a paper submission process. Most authorities will accept PDF-based NeES (a.k.a, non-eCTD Electronic Submissions), but still require paper as the legal basis for submission. This currently contributes to the delay in adopting eCTD, as each country requires legislation to pass through its respective parliamentary body to accept an electronic format as a legal document.

In this transition phase, pharmaceutical companies could be faced with creating different submission formats such as eCTD, NeES, ACTD (ASEAN Common Technical Dossier) and paper. At times, companies may be required to submit both electronic and paper formats to meet regional requirements.

The recent release of the S-Cubed suite includes the following new or enhanced capabilities:

  • NeES (Non-eCTD Electronic Submissions) - offers users the capability to create any type of electronic submission. The system is deployed with templates for CTA in Europe and ACTD for ASEAN countries. Users have the flexibility to create their own templates based on local agency requirements.
  • RLP (Report Level Publishing) - offers a flexible yet standardized platform to publish Clinical Study Reports as a single study report or by using ICH E3 granularity.
  • eCTD (Electronic Common Technical Document) - enhanced with many new features such as enhanced role-based security, bulk importing capability, a flexible repository and improvements to the user interface.

"The recently released S-Cubed® v4.1 will enable sponsor organizations to create, submit and manage any type of regulatory submissions required by agencies around the world today," explains Shylendra Kumar, President and founder of Datafarm. "Our goal is to provide simple, but regulatory-compliant submissions solutions to sponsor organizations. Until now, we had only the eCTD capability, which was limited to the US, Canada, EU and Japan. Now with S-Cubed® a sponsor of any size, in any country has the capability to submit their submission anywhere in the world."

Datafarm's software solutions, the entire suite or individual modules, are also available through SaaS model or by licensing model. The eCTD module meets current ICH and regional (FDA, Health Canada, EMEA and MHLW) requirements. The NeES module supports any type of electronic submission. The Publisher module supports paper dossier requirements. In addition, Datafarm's solutions include CTD Templates, PDF publishing solutions and regulatory submission outsourcing services. For details please visit our website at http://www.datafarminc.com.

About Datafarm, Inc.: Established in 1997, Datafarm is a leading provider of Regulatory Submission software and professional services solutions for the Life Sciences industry. Datafarm provides custom and off-the-shelf software solutions that produce high-quality and agency-compliant e-Submission-ready documents to customers worldwide. To date, the company's products have been used to compile thousands of eSubmissions. Datafarm's professional services team has partnered with industry sponsors to submit hundreds of eSubmissions to the USA, Canada, European Union, and Japanese regulatory authorities. Headquartered in Marlborough, Massachusetts, USA, Datafarm has regional offices in California, the UK, France, and India. Information about Datafarm's products and services can be found at http://www.datafarminc.com.

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