1 / 4

CDS Authoring and Labeling Support: Compliant, Timely, and Quality-driven Solutions

Real-world case studies showcasing successful authoring and updating of CDS and local labels, ensuring compliance, consistency, and high quality levels. Multi-year engagements with demonstrated outcomes.

urbina
Download Presentation

CDS Authoring and Labeling Support: Compliant, Timely, and Quality-driven Solutions

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. REAL-WORLD CASE STUDY #1 Authoring of CDS: Mature Products across TAs 100% Compliant Timelines & Quality 99.5% Right First Time Score Multi-year Engagement 120+ CDS Created/QCed 80+ COs Created/updated Business Need Solution Outcomes • Develop CDS and ensure consistency of local labels with the core data for mature products across multiple therapeutic areas • Prepare comparison tables and the summary of deviations • Reference search and authoring CO/tailored CO if required to support the changes • Team trained on client specific SOPs and WIs • Labeling and medical writers and reviewers; quality reviewer; scientific editors; project manager • Constituted robust communication and escalation channels • Established Governance layer for monitoring and improvement • 120+ CDS created/QCed • 80+ COs created/updated • ≥ 99.5% Right first time score with consistency • 100% compliance to Client timelines • 3rd year of engagement with current team size of 32 FTEs • Scope expansion to local label update/QC, labeling comparison and alignment

  2. REAL-WORLD CASE STUDY #2 Regional Hub for End-to-End Labeling Support 100+ Markets covered 100% Compliant Timelines & Quality 1100+ COs authored/updated 7000+ Label compared & updated/ created > 25,000 Artworks delivered Business Need Solution Outcomes • Critically low regional compliance levels observed during client’s internal audit check • Single strategic partner for managing time-critical labeling remediation activities • Large volume of labels to be updated across 350 plus product profiles and markets covering Asia, Europe, Africa and LATAM • Retrospective comparison and assessment of local label v/s CCDS to ensure consistency of information and regularizing submission to HAs • Multi geographic COE setup for flexibility with regional understanding and language expertise • 25FTEs (labeling & artwork experts, PM) deployed in 6 weeks • Seamless integration of client systems & processes • Multiple work streams that included authoring, updating, translating, proofing, alignment of local labels and artwork and pack management • 70+ dedicated resources • Zero observations during QC and Audit • 100% regional compliance maintained for all the markets • Supported with backlog clearance ~1000 labels in 2 months • 4th year of engagement: evolution of partnership into an end to end global labeling management

  3. REAL-WORLD CASE STUDY #3 Partner for Client Labeling Operations 100% Compliant Timelines & Quality Multi-year Engagement <0.5 Error Rate Right First Time Score 2500+ Local Labels Updated 10000+ Comparisons Performed 2000+ COs Created/updated Business Need Solution Outcomes • Large volume of retrospective labels to be aligned to the latest CCDS and safety information by providing justifications • Label updates, Clinical overviews and Artwork remediation activities across >120 markets • End-to-End Project Management • 40+ trained labeling experts on-boarded within 6 weeks with complete transition of work • Team trained on client specific SOPs and WIs • An Onsite Project Manager placed for better communication and reachability • Proprietary platform deployed to coordinate/ track/ trend/ report activities with nearly 150 local affiliates • Team size increased to 65 FTEs within 2 years • Scope expansion to include consumer and nutritional products

  4. REAL-WORLD CASE STUDY #4 Label QC and Proofreading Engagement 100% Regulatory Compliant 1100+ COs authored/updated 99.9% first time right 2000+ Labels QCed > 4000 Artworks proofread Business Need Solution Outcomes • High-volume local label updates required a QC review to ensure consistency and accuracy • Client was looking for cost-effective model to support Quality check, Editorial review and Proof-reading of CDS, Local Product/ Patient Labels and Artwork • The expected volume to be delivered was >2000 labels and >3000 artworks per year • Strategic offshore hubs at Bangalore and Shanghai, leveraging geographical diversity and scale • Centralized teams of 5 Labeling reviewer and 10 proofreader to manage multiple geographies • CDS reviewed for consistent medical information across different sections, consistency in language, style and formatting • Workshops with client to stay ahead of global regulatory trends and new labeling technology • Expanded to include multiple other global destinations through a shared-service model • 4th Year of engagement with 3000+ labels proofread per year

More Related