Issue Management
Resolve clinical data issues more efficiently with one collaborative platform
Assess, triage, and save corrective actions for faster resolution
You’ve performed data validation. You know the issues. But now you’ve got the painstaking process of reconciling clinical data issues with decentralized teams. Plus there’s dataset and standards versioning to keep on top of! With only email chains and spreadsheets, there’s a lot of back and forth, and no visible audit trail to keep track of fixes.
Think of the manual work and delays you could avoid with a centralized issue management platform! Pinnacle 21 Enterprise (P21E) allows you and your stakeholders to work together, in real-time, on data validation and compliance fixes. With one platform for communication and reconciliation, you’ll always work off the most up-to-date information, and know exactly where your submission progress stands.
Why use P21 Enterprise to manage clinical data issues?
One collaborative platform
Stop tracking down answers in long email threads or local spreadsheets! Instead – identify, communicate, and resolve clinical data issues together in one central platform. Maintain a ‘single source of truth’ that’s always up to date. Refer to issues over time and across studies to make consistent corrections.
Detailed issue explanations
Get detailed, actionable intel on every issue, including specific rule violations and their impact on regulatory compliance. Supplement these details with your own custom issue details, such as fix tips, company-specific tags, and issue explanations.
Submission readiness score
Each data package is assigned a ‘data fitness score’ between 0-100. This gives a clear measure of how close you are to submission readiness. P21E tells you which issues to fix as a priority, based on the impact it will have on your data fitness score.
Expert guidance
Our proven ‘Fix Tips’ and company specific advice guide you towards issue resolution. Supplement this with your own company-specific advice for your teams.
Greater quality & compliance
With a central platform for issue resolution, and clear oversight of priority fixes, you’ll soon improve data quality and regulatory compliance. Now you can de-risk your submissions – and get them submitted earlier too!
Enterprise-wide oversight
Track trends and key KPIs, such as the number of reject issues, validations per study, and projected scores. And now you can optimize resources by tracking team activity across projects.
Already using P21 Community? Here’s the issue management tools you’re missing in P21 Enterprise…
Software features | P21 Enterprise | P21 Community |
---|---|---|
Validate SDTM, SEND, ADaM, and Define.xml |
✔ |
✔ |
Metadata driven and configurable |
✔ |
✔ |
Data composition and quality reports |
✔ |
x |
FDA Data Fitness assessment scorecards |
✔ |
x |
Manage issues throughout the study lifecycle |
✔ |
x |
Communicate and collaborate with partners |
✔ |
x |
Monitor data quality improvement over time |
✔ |
x |
Track changes across validations |
✔ |
x |
Customize specs for SDTM+ or sponsor formats |
✔ |
x |
Design rules for projects, studies, and partners |
✔ |
x |
Join +2,000 organizations – including the FDA, PMDA and 24/25 Top Pharmas – who are resolving clinical data issues with P21E
Track your real-time progress towards submission readiness… see how!
Reduce risk & increase chances of approval
The ability to track submission progress in P21E means you can be confident knowing when you’re ready to submit – and when you’re not! That way you can avoid the risk of a failed submission. Live data fitness scores tell you which clinical data issues to tackle as a priority, and when you’ve made enough progress to gain that all-important approval.
Get a free demo of Pinnacle 21 Enterprise Clinical Data Management & Automation Suite
Complete the form to book your no-obligation demo of the P21E Clinical Data Management & Automation Suite… and see how better off you could be!