监管机构依赖清晰详细的文档来审阅临床数据提交。The Study Data Reviewer’s Guide (SDRG) provides essential context and clarity, expediting the review process.
However, manually compiling and formatting this guide can be time-consuming and prone to errors. Pinnacle 21 Enterprise revolutionizes this process by automating content aggregation and formatting, allowing you to generate a complete SDRG with just one click.
Pinnacle 21 Enterprise simplifies the creation of your Study Data Reviewer’s Guide by automating key processes. From pre-populating templates to importing existing issue explanations, the platform ensures accuracy and efficiency.
Manually collating and formatting your content is time-consuming and inefficient. The P21E platform pre-populates your study data reviewer’s guide template with trial design and summary, subject data, study metadata, and validation results. This applies to all clinical, non-clinical, and analysis data, including SDTM, SEND, and ADaM.
Alot of time is typically spent tracking down explanations in the run up to submission. But rather than duplicating work, with P21E you can reuse existing study content. If you’re using our Issue Management module, your explanations will already be approved. Simply import them straight into your Study Data Reviewer’s Guide for maximum efficiency!
With content and formatting taken care of, all that remains is to generate your finished document. The P21E platform automatically creates your Study Data Reviewer’s Guide – with a simple click of a button!
Providing a SDRG helps reviewers understand any special considerations or directions related to your FDA submission data. Without it, your data could be open to misinterpretation, or may lack valuable context. P21E’s SDRG automation platform equips you with the tools to thoroughly and efficiently advocate for your data, and persuade reviewers – boosting your chances of submission approval.
Rather than manually searching for issue explanations at the last minute, pre-approved explanations can be instantly imported into your reviewers guide. Now you can avoid the risk and stress of submission delays when finalizing your document!
With a pre-populated SDRG template, imported issue explanations, and formatting taken care of, you’ll save lots of time consuming manual work. And with one-click to generate your reviewers guide document, you’ll make even more time and resource efficiencies.
Your Partner in Regulatory Success
Certara’s Pinnacle 21 Enterprise ensures your data is submission-ready through the lens of the regulators. Trusted by hundreds of pharma, biotech, CRO, and regulatory organizations, the platform streamlines your submission process, and enhances approval outcomes.
With unmatched expertise in clinical data standards, our support team provides the reliability and technical knowledge needed to optimize trial conformance – ultimately empowering you to bring life-changing therapies to market faster.
Got a tight deadline or need some help creating your Study Data Reviewers’ Guide? Our experienced technical support team are here to ensure your submission deliverables meet the exacting regulatory standards required for approval.
Certara is ISO-certified, ensuring the highest level of data security and compliance for your clinical study submissions.
Experience the Pinnacle 21 Enterprise advantage
Discover how Pinnacle 21 Enterprise can simplify your SDRG creation process and enhance your FDA submission success.
Automate SDRG creation with pre-populated templates.
Save time by importing pre-approved issue explanations.
Generate your SDRG with a single click.
The purpose of the SDRG is to thoroughly explain the clinical trial submission data, since it often diverges from ‘the norm’ and requires further clarification. It provides a mechanism to preempt potential queries and present supporting information or context upfront – to avoid ambiguity and make it easier for FDA reviewers to understand.
The document contains information related to the clinical study, including: the study design; data standards; data collection; and description of the datasets. It also contains special considerations or guidance that could help the agency reviewer understand the correlation between the study report and supporting data.
Yes! There are various versions of the SDRG, and the Pinnacle 21 Enterprise platform includes its own easy to follow template. The SDRG template follows a typical structure, but it’s also flexible enough to be customized accordingly. Some sections can be ignored if not applicable, and likewise additional content may be added as needed. Using a Study Data Reviewer’s Guide template means you’ll be providing FDA reviewers with all the information they’re expecting. So it’s an extremely beneficial tool to have!
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