DxTemplates for Life Sciences

Start off right - and fast with templates for regulatory needs.

Structured content authoring and management with easy to use templates designed to fulfill regulatory needs.

Trends in transparency and harmonization coupled with newly available content management technologies are leading to significant changes in the way that life sciences organizations worldwide are writing, storing and maintaining their regulated information. Traditionally, content management solutions have been deployed to store this regulated content as complete documents. Unfortunately, this approach severely limits an organization’s ability to repurpose critical information increasing the likelihood of inconsistent and even incorrect information.

Dx4 offers a better way to create, manage and deliver this information through structured re-use of content while enabling consistent publishing in any format.  It is a structured authoring and management solution that helps life sciences companies reduce time and costs spent in authoring key documents by placing required information into “topic areas” that can be pulled together using topic maps as needed to fit the regulatory need. But, with so many regulations, where do you begin?

Introducing DxTemplates for Life Sciences from DitaExchange. Start your content authoring evolution with a robust collection of document and topic templates that have been designed by industry experts to streamline the authoring process and ensure accurate and complete regulatory document output related to the Quality Overall Summary of the Common Technical Document as well as Clinical Trial Documentation.

Using the EDM reference model, DxTemplates enable organizations to quickly start building content based on best practices for structured content management. For a complete listing of available maps, contact us today.

 

DxTemplates for Life Sciences provide:

  • Faster turnaround time for rest-of-world (ROW) registrations
  • Decreased authoring and administrative time to convert documents to new regions
  • Easier identification of differences between approved applications
  • History of changes contained within single file
  • Flexible authoring practices

Clinical Trial Documentation

As clinical trial documentation is also highly regulated and repetitive, a set of maps and topics relating to the Clinical Trial Protocol Synopsis, Clinical Trial Protocol, The Statistical Analysis Plan (SAP), The Clinical Study Report (CSR) and Investigators Brochure (IB) have also been created. This collection provides dozens of topic templates and document templates, creating and organizing your clinical trial documentation in fashion that is designed to enable reusability, consistency and quality. Examples include:

  • Abbreviations
  • Administrative Rules
  • Assessment of Investigational Product
  • Discussion and Overall Conclusions
  • Drug Product
  • Effects in Humans
  • Efficacy Evaluation
  • Ethical and Regulatory Standards
  • General Information (title, study roster)
  • General Precautions and Warnings
  • Handling of Patient Withdrawal
  • Introduction
  • Introduction and Rationale
  • Investigational Plan
  • Nonclinical Studies
  • Patient Safety
  • Pharmacokinetics and Product Metabolism in Humans
  • Physical, Chemical and Pharm Properties
  • Possible Risks/ADRs, Contraindications
  • Safety and Efficacy
  • Safety Evaluation
  • Selection of Patients
  • Statistical Considerations
  • Study Design
  • Study Monitoring
  • Study Objectives
  • Study Patients
  • Study Procedures
  • Study Treatments
  • Summary of Data and Guidance for Investigator
  • Toxicology

Common Technical Document Templates

SCM is especially useful for handling information contained in the Quality documents that feed into the Common Technical Document (CTD).  The information required to complete the Quality Overall Summary, in Modules 2 & 3 contains a significant amount of data that can – and should – be reused to provide consistency and accuracy throughout the submission.  By structuring this content into topic areas so that it can easily be placed as needed into all necessary parts of the file, organizations can eliminate much rework typically associated with creating these documents.

DitaExchange has built dozens of maps and topic templates that adhere to the ICH guidelines for the Quality sections of the CTD helping to ensure that customers build the right documents the first time – saving even more time and effort.

Over 65 templates for Modules 2 and 3, including instructional text, are now available. The templates  provide structure as defined by ICH guidelines for authoring submission content and publish region specific documents complete with standard numbering and formatting submission-ready PDFs.


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