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Optimizing Submission Document Processes: Building Up Quality by Tearing Down Barriers
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Introductions
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Sherry Kappel Chief Innovation Officer Microsystems
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Connie Lieu Director, Process Solutions Octagon Research Solutions
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AGENDA
Introductions Optimizing Document Submission Processes Process Considerations & QC/QA Best Practices – Plan & Author – Review & Finalize – Publish & Submit Conclusion Question & Answer Wrap-up
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Octagon Research Solutions
The eSub Experts – Octagon Research Solutions was founded in 1999 as a Development Partnering Organization providing services and software to the biopharmaceutical industry
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Our goal is to synchronize processes and increase automation to reduce the island-to-island inefficiencies within clinical research and development. – – – –
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Regulatory Affairs Consulting and eSub Production Capabilities Assessments, Roadmaps & Process Refinement Clinical Information Management Innovative IT Solutions • ViewPointTM • StartingPoint
Our process approach leads to systemic improvements that provide significant time and resource savings resulting in quicker availability of new therapies.
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Microsystems
THE document experts – Improving eSub Document quality, integrity and productivity • • • •
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Process Software Services Solutions
Jointly-served such companies as: – – – – –
AstraZeneca Johnson & Johnson Sanofi-Synthelabo Cephalon Endo Pharmaceuticals
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External Factors
Escalating R&D costs vs. pressure to decrease drug prices – Requiring innovative approaches to discovering new efficiencies
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Global agencies moving to electronic submissions – Many formats currently accepted
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Evolving standards for eSubs (eCTD, CDISC, SPL, etc.) – Moving targets for R&D organizations – Require flexibility to support multiple formats for global submissions during transition phases
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Internal Challenges Changing standards require updated processes – Transitional strategies must address technologies, processes and new requirements for deliverables
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Limited understanding of electronic submission deliverables across functional areas Sporadic use of standards such as templates – Rework may not be automated – CROs and partners – Issues are often identified late in process
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Evolving requirement for reuse of legacy content – Requirement for predictable output that can be leveraged consistently for reuse
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Requires an organizational “Submission Document Strategy”
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Optimizing Document Processes
What is the Optimal Submission Document Process? •
Document Process is the planning, creation and managing of components for regulatory submissions – It is not just content creation, but also understanding the content in context of previous submissions to multiple regulatory agencies – End result should be the efficient production of compliant deliverables
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The ultimate goal is to optimize the document process which includes… – – – – –
Keeping the end goal in mind of having submission-ready documents Minimizing rework and redundancies Implementing organizational standards Automating the appropriate functions Building quality into the process
Optimizing Document Processes
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Plan & Author
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Review & Finalize
Publish & Submit
Plan & Author – What is the planned use, re-use and delivery?
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Review & Finalize – Who will be reviewing & what is being reviewed?
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Publish & Submit – What documents are available & how do they relate to previous submissions?
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Process Factors & Considerations
Plan & Author
Implement Document Standards – Style Guides and Authoring Templates – Foster a corporate standard for document quality & consistency across authors & functional areas – Automate downstream publishing activities
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Define Type of Document, Metadata & Lifecycle – Facilitate quick searching and retrieval – Enforce business rules & ensure proper access/use – Necessary for lifecycle management
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Get Partners Involved Early – Deliver content using your standards, meeting your timeline
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Communicate Timeline – Contribute to proper planning and quality deliverables
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Tools and Training – Ensure quality submission deliverables
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Document Process Impact
Plan & Author
Understand and remedy your systemic document process/content issues
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Template’s performance against each process phase • Plan: Rapidly-evolving standards • Publish: Is structure applied? Are review elements removed? Author’s performance against the template • Varying requirements, by document type • Each refinement creates need for update training
Predictable reuse of legacy content – – –
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Plan & Author
Challenging to align –
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QC/QA Challenges & Best Practices
Word 6/95 or WordPerfect PDF or Scanned content Intranet/Web content
Challenging to ensure integrity throughout the lifecycle • Confident reuse • Quality and integrity checks • Automated assessment
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The overall challenge –
Minimize rework, increase efficiency, downstream predictability, continuous improvement
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Plan & Create Template Rules Author
Template auto-generates the business rules
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Process Factors & Considerations
Review & Finalize
Plan & Review Milestones – Define QC/QA steps at logical milestones in your process – Document standards in adequate detail for reference – Provide review access to facilitate process and information exchange
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Roles & Responsibility – Reviewers must understand the standards and the content of the final deliverables – Reviewers understand their roles/responsibilities and use of tools
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Online Review & Annotation – Facilitate quicker delivery of esub-ready documents
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Submission Ready Documents – Define “FINAL” and “SUBMISSION-READY”
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Review Factors & Impacts
Ability to track types of issues, measure review times, rework and coordination of resources
Review & Finalize
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QC/QA Challenges & Best Practices
Review & Finalize from internal sources ; House Styles applied
; Page numbers inserted
; Hyperlinks inserted
; Margin requirements met
; Cross-references accurate
; Colors/shading removed
; Pagination fidelity into PDF
; Comments eliminated
Review & Finalize from external sources ; Proper PDF version ; Fonts are embedded ; Margins accurate
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Challenges faced – Where to invest what resources, first… – Targeted education => process improvement – Inevitable need for emergency expertise
Review & Finalize
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Automated analysis identifies content & formatting issues during review & finalize phase — not the critical Publish & Submit phase
What?
Review & Finalize
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Isolate & Fix
Review & Finalize
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Process Factors & Considerations
Publish & Submit
Proactive Publishing Activities and Submission Review – Build quality early in the process – Plan review early in process for proactive measures – Determine QC checks based on deliverable requirements
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Submission Strategy – End result is an efficient production of compliant document deliverables – Track development of each submission component throughout entire process – Monitor status of each task for an individual component – Track document-related issues, address root causes and adjust process for new document creation/delivery
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Lifecycle Management – Track the use of a submission component or related components throughout the lifecycle of a submission
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Submission Process Metrics
Track development of each submission component throughout entire process
Publish & Submit
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QC/QA Challenges & Best Practices
Publish & Submit
Challenges – Excessive & unmanageable resource allocation at submission time – Availability of appropriately-skilled resources – Process duplication & wasted time
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Specific issues or indicators common to this phase ; ; ; ; ; ; ; ;
Version & origin of the PDF Absence of security & restrictions Page numbering sequential Page Size & Margin settings Comments eliminated Symbols accurate in bookmark name/title Fonts are embedded Print optimization & view settings
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Publish & Submit
A workflow view
Pre-clinical, Clinical Authoring Phase
Regulatory Operations, Regulatory Affairs Phase
Before and After Reuse Upon receipt from CROs
Before Placing in Doc Repository
Automated Analysis, Repairs
After Rendition to PDF
Automated Analysis
Predictable Publishing
Submission, FDA & EU
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Map for Success
End Goal: Enable efficient production of compliant and quality document deliverables for regulatory submissions, minimizing rework and redundancies • • • • •
Creation of documents to support the end goal Proactive and automated QA/QC processes Track and understand your document issues and metrics for proactive planning Cross-functional collaboration on document processes to ensure efficiencies, reduce rework and mitigate issues/risks Constantly reinvest in your process – – –
Conduct cross-functional training Refine processes based on previous experiences Evaluate process for opportunities for automation
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Action Plan
Understand current state & develop actionable metrics – Understand and track document process issues & bottlenecks – Compare metrics across document types – Review common CRO issues and service agreement
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Evaluate potential cross functional process changes – Look at “island to island” inefficiencies – Reduce rework and integrate functional silos – Align document processes with submission goals
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Assess opportunities to automate QC/QA – Labor-intensive, tedious and repetitive tasks
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Develop change management plan/processes – Reports provide a baseline comparator for future projects and more proactive planning
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Question & Answer
Time is that quality of nature which keeps events from happening all at once. Lately it doesn't seem to be working. -Anonymous
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Thank You
Connie Lieu
Sherry Kappel
Octagon Research Solutions 610.265.8300 www.octagonresearch.com
Microsystems 215.836.1266 www.microsystems.com
clieu@octagonresearch.com
sherryk@microsystems.com