DxTemplates for Your ContentStart off right - and fast with templates for your needs.
Structured content authoring and management with easy to use templates designed to fulfill your needs.
Let’s take a look at how DxTemplates are helping the pharma industry meet regulatory requirements.
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
- 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 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
Common Technical Document Templates
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.