The success of any clinical development program rests on the quality of documentation provided for regulatory agency review. Ensuring that this documentation is consistent, accurate, and compliant with regulatory agency requirements is crucial.
Certara’s specialist Document Quality team offer the following supporting services, freeing your team to focus on where they add most value: content, data, and clear messaging.
- Quality control (QC)
- Document-level formatting
- Document-level publishing
- Document quality leadership
- Style guide and template support
Whether you’re a small company planning your first clinical study or a large company managing a varied portfolio, Certara’s Document Quality team has the scalability, flexibility, and experience to support your unique needs.
Quality Control
All documents written by Certara undergo our QC process, but we also offer QC on an ad hoc basis for documents written by our clients.
Whether you need a comprehensive QC of an entire document or a more targeted check that focuses on particular sections or specific QC tasks, we can help.
- Our highly trained team follow applicable SOPs and perform content verification as well as editorial and formatting checks.
- Our large, global resource pool has the flexibility to meet challenging timelines and accommodate tasks with little notice, as well as the scalability to handle high-volume requests.
- Our team members are located throughout North America, Europe, and the Asia-Pacific region, allowing for around-the-clock support.
- Certara’s Document Quality team have QCed documents for numerous successful NDAs, BLAs, INDs, MAAs, IMPDs, and more.
- Our personalized approach provides a designated Document Quality Lead who will facilitate all requests, understand your unique needs and preferences, and build a valued partnership.
Document-level Formatting
The detailed content and format specifications from regulatory agencies are designed to facilitate quicker reviews, but understanding these requirements can be daunting.
Document-level formatting increases efficiency and promotes compliance by ensuring appropriate styles are applied and essential document navigation features are functioning, smoothing the conversion to PDF during publishing.
Our specialist team can efficiently format your documents for consistency with your preferred styles and/or templates, saving your team time, budget, and headache. We are experts in the Certara eCTD Authoring Templates but versatile enough to be proficient in the use of other suites.
Document-level Publishing
Document-level publishing ensures submission readiness and eCTD compliance for all electronic documents prior to submission compilation. Efficient document-level publishing adds value in many ways, through:
- Creation and review of navigational features (e.g., linking and bookmarks), alignment to submission plan, and other updates to ensure that each document aligns with the relevant regulatory agency guidance
- Ensuring that all formatting, cross-referencing, and other technical elements smoothly and effectively convert from Word to PDF
- Facilitating flexible use of the final document for multiple regulatory agencies and submission platforms
- Addressing validation error-causing elements prior to incorporating the document in the eCTD structure.
For information on Certara’s regulatory operations support, click here.
Document Quality Leadership
An established, consistent, single point of contact leads our cohesive review team of highly qualified editors. This Document Quality Lead coordinates activities across one or more regulatory documents to maximize efficiency and effectiveness in each QC, formatting, or publishing task.
Our Document Quality Lead offering also provides a technical expert to answer all of your questions and advise on best practices relating to:
- Document management
- Content plan maintenance
- Style guides
- eCTD Authoring Templates
- Microsoft Word glitches and corruptions
- EndNote
- Literature reference purchasing
Style Guide and Template Support
Standardization tools that ensure consistent formatting, style, and terminology are fundamental to maximizing efficiency during document development.
Our Document Quality team is highly experienced in the development and update of style guides and lexicons, expertly combining client preferences with regulatory requirements.
We’ve paired our technical experts with our team of qualified consulting professionals in regulatory process and regulatory writing to create a comprehensive eCTD authoring template suite based on decades of experience planning, writing, and editing hundreds of global submissions.
The numerous template features simplify document creation and review, and establish a standard approach to document development across different disciplines to ensure efficiencies between writing and regulatory operations teams. Our templates benefit from:
- Instructional text incorporating current agency guidance maintained by regulatory experts
- Specialized toolbar containing standardized shortcuts and symbols
- Access to expert advice and technical support at all steps along the way
Our Document Quality team are experts on how to use our authoring templates but are versatile enough to support alternative suites.
