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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.

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

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  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

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