The pharma industry is a serious business, and medicines that have a real chance at changing lives deserve a review without hiccups and delays. You need to be confident that you're submitting clean, compliant data every time.
That's where technology comes in – but which tools best meet the needs of your team, and what's the difference? When is it the right time to “level up” your tech stack to ensure your submission is ready for review?
Pinnacle 21's Principal CDISC Consultant Julie Ann Hood and Product Success Manager Jennifer Manzi show how purpose-built technology can impact and improve your workflow, and highlight major differences in functionality between P21's open-source Community tool and our cloud-based Enterprise platform.
Major Differences: P21 Community and P21 Enterprise
| P21 Community | P21 Enterprise |
Issue Management & Collaboration | Shows a list of problems with your data only, in XLSX format Suitable for working alone Relies on spreadsheets that must be shared via email | Shows which problems matter and how to fix them; empowers teams to prioritize fixes by impact Provides users with Data Fitness Scores Best for working seamlessly in the cloud with a team; Communicate directly in-app and assign tasks for action and review |
Define-XML & Reviewer’s Guide | Requires manual work by programmers once a spreadsheet is converted to XML; no support for Reviewer’s Guide | Provides visual editors and automation for Define-XML and Reviewer’s Guide creation |
Data Validation | Offers basic checks, but no guarantee for timeliness or accuracy | Always 100% in sync with regulatory agencies Delivers automatic updates to engines, standards, and terms |
Traceability | Forgets everything you do as soon as you’ve finished | Accumulates history of validations, assignments, fixes, and more CFR Part 11 compliant |
❓ Why Pinnacle 21 Enterprise?
Fast facts:
Adopted by 24 of Top 25 biopharmaceutical companies, and multiple global regulatory agencies, including US FDA and Japan PMDA; over 2,400 organizations served
Reduces time to produce define.xml and Reviewer's Guide by 60% (SDTM) and 85% (ADaM) via visual editors and automation
Optimizes for compliant, conformant datasets early during the trial, even with samples sizes of under 10% patient enrollment
Relied on for "warp speed" regulatory submissions, enabling regulatory decisions in under 3-4 weeks with zero data-related information requests
36+ trillion data points validated, in support of 519+ treatments approved, with massive-throughput cloud computation on TB-sized files
P21 Enterprise-exclusive "P21 Engine" that supersets the business rules of all regulatory agencies, to drive efficiency for "multi-agency, multi-market" submissions
Powers synchronous online collaboration between Data Management and Statistical Programming teams as large as 1,300 users—with no need for offline spreadsheets or manual reconciliation steps
98% customer satisfaction rate for our response time and value-based consulting services from our CDISC, regulatory submission, and data science experts
❗ Challenge: The FDA stopped publicly publishing Severity rank.
P21 Community produces only an unranked list of Issues, with no indication as to which Issues are important, significant, or ignorable.
P21 Enterprise lets you focus on impactful fixes for Issues that matter most. Invest your billable hours for your client in work that makes a difference in the actual delivery, assessment, and submission process by easily identifying Issues by Severity rank and tackling the most important ones first.
🔍 Challenge: Your team needs traceability.
P21 Community has no "memory." It is a desktop tool for individuals, and it automatically forgets all settings, results, and metrics the instant each validation is run. Community offers no historical logs or traceability.
Leverage objective, quantifiable metrics to optimize the quality and profitability of each team with P21 Enterprise. Enterprise provides the tools you need for informed decision-making, so you can allocate team members towards the studies most-at risk.
📦 Challenge: You need a clean, delivery-ready package with a Reviewer’s Guide and all supplemental documents for stress-free submission.
P21 Community offers zero support for the Reviewer's Guide, but that Guide is a mandatory part of every submission and is the main document to which agency reviewers refer.
P21 Enterprise produces a living Issue Summary and Reviewer's Guide that is always up-to-date and perpetually delivery ready. Sponsors perceive (and pay for) the value in more frequent deliveries. Deliver on time and meet sponsor demands easily and efficiently by front-loading and reusing existing work with little additional effort.
📂 Challenge: You struggle to produce a clean, submission ready Define.XML file that doesn’t cost a fortune in billable hours to create and perfect.
Though P21 Community offers the ability to scan XPTs and export XML or XLSX files to form the basis of a define.xml, it offers no way to improve and edit to produce a submission ready define.xml.
P21 Enterprise empowers generalist staff to create and maintain an accurate, high-quality define.xml in record time. For CROs, creating and maintaining accurate define.xml can take between 40-80 hours per study and is often done by “specialists.” With Enterprise, you’ll spend less time and money to produce a high-quality define.xml guaranteed to satisfy sponsors and regulatory agencies alike.
Prioritize, Analyze, Collaborate, & Automate
🧠 Prioritize fixes for Validation Issues intelligently with the P21 Enterprise-exclusive P21 Validation Engine
P21 Enterprise scores each Data Package with a Data Fitness Score (0-100), so that you have an objective measure of when it is submission ready (>90 points).
Only P21 Enterprise allows you to project future Data Fitness Scores months in advance of actual data deliveries.
P21 Enterprise shows rich, actionable details for each Issue: Review Impact (Reject, High, Medium, Low) for how critically regulatory agency tools will be hurt by Issues, Message Type (Error, Warning, Notice) for the probability of how likely the Issue is to be true, and Fix Tips for stepwise data troubleshooting steps written by P21 Subject Matter Experts.
Only P21 Enterprise lets you supplement these details with your own custom Issue details: Fix Tips, company-specific tags, and company-written Issue Explanations.
📈 Analyze your portfolio and monitor progress over all team activity
Only P21 Enterprise supports folder hierarchy, access and security controls, and remembers settings and results over time.
P21 Enterprise lets you roll up metrics from package to portfolio level and track KPIs to view trends in and across trials, with unlimited archival hosting of artifacts and historical records as living documentation. These auto-archives spare teams hundreds of hours of saving spreadsheets and moving things around shared drives and email.
Only P21 Enterprise offers an executive Analytics module with alerts for Reject or recurring Issues to target company-wide conformance vulnerabilities. Monitor study team activity across milestones and aggregate comparisons of data fitness across projects or phases or therapeutic areas.
💬 Collaborate on Issue resolution & automate Reviewer’s Guides for 100% perfect supporting documentation
Only P21 Enterprise offers an in-app ticketing workflow for managing Issues and auto-converting the unfixable ones into perfect Reviewer's Guides.
Only P21 Enterprise lets you delegate, filter, and tag Issues across teams, apply bulk actions for added speed, and auto-reconcile results at each validation. You can standardize stock Issue Explanations for output into perfectly formatted, hyperlinked, and standardized Reviewer's Guides per agency requirements in just one click. Maintain all the cross-team chat in the cloud along the way.
📑 Automate define.xml and reduce Issues in the color-coded, expandable in-app Define Designer
P21 Enterprise auto-creates define.xml from validation metadata with advanced options for merging (or partially merging) changes introduced over time, creating defines from global standards, or reusing defines from other studies.
P21 Enterprise offers an in-app editor with real time cell validation to validate all content for internal consistencies and cross-checks with underlying datasets via instant color-coding and instructional tips.
P21 Enterprise offers convenient cell-level "builders" to augment spreadsheet work. Switch easily between the on-screen editor and guided in-cell builders to spreadsheet tools such as Excel and back again. Export multiple formats: XLSX, XML, XLS, PDF.
P21 Enterprise lets you extract origin page numbers from aCRFs in seconds.