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INDEGENE Medical Devices Solutions

INDEGENE Medical Devices Solutions. January, 2018. REAL-WORLD CASE STUDY. 1. Notified Body Submission for CE Approvals. 12+ Resources deployed within 4 weeks. 30% Productivity gained for client. 50+ Documents annually. 100% on Compliance, Timelines & Quality. Outcomes. Business Need.

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INDEGENE Medical Devices Solutions

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  1. INDEGENE Medical Devices Solutions January, 2018

  2. REAL-WORLD CASE STUDY 1. Notified Body Submission for CE Approvals 12+ Resources deployed within 4 weeks 30% Productivity gained for client 50+ Documents annually 100%on Compliance, Timelines & Quality Outcomes Business Need Solution • Successfully cleared client audit with no major observations • Regulatory documents, publications, white papers across 3 continents • 100% compliance; <0.5 errors/page • Supplier score card rating of “Exceptional” in the year 2013 and 2015 • Overall productivity gain of 30% for the client through the COE model. • Client Clinical and Regulatory team required turnkey support to manage their Regulatory planning and submissions • Author submission documents to Notified Bodies in CE marked countries • Regulatory/ safety documents, study reports, respond to NB/HA queries • GAP analysis of SOP/DOPs, Web disclosure, Clinical trial analytics, White papers • Dedicate COE team – Medical writers, reviewer, Editor/ QC, Analysts • Comprehensive remote training process on client specific SOP • Monthly operational review to monitor engagement health. • Client provided approved template and final sign-off on the document. • Review meetings with the client point of contact for review comments resolution

  3. REAL-WORLD CASE STUDY 2. Multi-geography Support For Clinical Evaluation Report Submission 12 Client SPOC managed End-to-end Document management 40+ Documents developed/updated Outcomes Business Need Solution • Onsite training on client SOPs, products for Medical reviewers. • 25 EU CER, 17 EU CFDA and 2 manuscript polishing executed within 18 months • Expansion into FTE model for medical writing support • Due to limited bandwidth, comprehensive solution required to manage Clinical Evaluation Reports (CER) submission to TUV and China FDA • Respiratory, Neurovascular, Endovascular and Surgical devices • Adjuvant medical writing support: Literature summaries, manuscripts and data tables • Dedicated team setup to provide support for India, US, and China based Client POC • Experienced team of Senior medical reviewer and medical writers • Conversant with client’s products, systems and processes within a very short time. • Staggered approach to manage critical timelines. • End-to-end document management from search strategy to submission-ready draft

  4. REAL-WORLD CASE STUDY 3. Fast Turn-around Clinical Evaluation Report for E.U. Submission in 15 Working Days CER submitted in 15 days Critical timeline 170 articles summarized Outcomes Business Need Solution • Clinical evaluation performed within 15 days • Minimal changes to the voluminous first draft • Expansion of the FTE model to multiple critical CER project requests • Stringent timeline requirement for CER submission to a Notified Body • Complex topic in neurovascular therapy area, multiple indications • Compliance with MEDDEV 2.7/1 Rev 4 guidelines • Experienced, offshore team of 1 medical reviewer and 2 senior medical writers • Monitoring timely receipt of all the source documents; clear understanding of scope • Project update calls on need basis for mutual discussions with client • Proactive updates regarding risk management workbook, benefit-risk profile

  5. REAL-WORLD CASE STUDY 4. Clinical Evidences For Risk-benefit Profile And Market Positioning Regulatory strategy Defined based on the analysis 10+ Databases & guidelines reviewed ~ 400 Articles analysed Outcomes Business Need Solution • Screened ~400 articles to analyse the current treatment landscape • Positioning of the product in the treatment landscape • Brainstormed to finalize next steps for the device based on the risk-benefit ratio • Final delivery within one month • Review clinical evidences and safety data to develop risk-benefit profile and market positioning • Review of literature across multiple databases and guideline recommendations. • Experienced Medical reviewer led team of Medical writers • Authored “State of the Art” section which provided relevancy of client’s device. • Partnered with US-based SME for expert review finalizing regulatory

  6. REAL-WORLD CASE STUDY 5. Publication Management 2.18 Impact factor 5 weeks For first draft submission 20% Client effort reduction on coordination >4/5 Client expectations Outcomes Business Need Solution • Review article successfully submitted and published http://www.ncbi.nlm.nih.gov/pubmed/26386235 • Healthcare organizations in US West Coast wanted to publish a state-of-the art review on the current concepts and overview of clinical evidence for a vascular device • Recommend target journal and facilitate paperwork for journal submission • Offshore team of CMPP certified medical director deployed • Scientific editor and graphic designer to ensure adherence to journal specification • Literature review across multiple database with specific insights on the technique and learning curve • Data interpretation to develop the review article • Periodic, regular interaction with the author to synergize approach to review article

  7. REAL-WORLD CASE STUDY 6. Scientific Communication ZERO Quality concerns 4 Client points of contact 40+ Documents developed/updated in a year 99.7%on Timelines Outcomes Business Need Solution • Annually 12+ CERs, 15+ CRBAs, 20+ evidence briefs and data tables. • Subsequent expansion into yearly contract of five (5) FTEs • Expansion to multiple TAs • Dedicated support to manage varying requirements and timelines of scientific content development • Clinical evaluation report (CER), clinical and risk benefit analysis (CRBA), literature search, data tables, product communiques, medical slide decks, QC tasks, device validation report, newsletters/Lit alerts, manuscripts. • Dedicated offshore team of one senior medical reviewer and two medical writers • Training on client’s products, SOPs, and processes within 2-weeks • Single point of contact assigned for all project related discussion and final review • Staggered approach to manage critical timelines for various deliverables.

  8. REAL-WORLD CASE STUDY 7. Evidence brief for Advisory Committee ~ 500 Full text articles reviewed 10+ Medical writers deployed Critical timelines of 10 days ~ 10,000 Articles screened Outcomes Business Need Solution • Consortium of five (5) Global device companies wanted to analyse clinical evidence for chronic venous disorders • Conduct as per Agency for Healthcare Research and Quality (AHRQ) guidelines • Present to Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), for expert advice to Centers for Medicare & Medicaid • Critical timelines of 10 working days • Lit screen, review, analyze and synthesized clinical evidences • Dedicated team of 10 medical writers and 3 reviewers deployed to manage literature screening for a period of 15 years • Analysis based on study outcome, results and Classification system for Chronic Venous disorder (CEAP) • Successfully submission to MEDCAC • ~500 articles reviewed • End-to-end coordination and review • Successfully met the stringent timelines

  9. REAL-WORLD CASE STUDY 8. Clinical Trial Disclosure 20+ Client POCs 50+ Trials 3+ Years Engagement 100% Compliant - SOP, Quality, and Timelines Outcomes Business Need Solution • CVS clinical research team wanted clinical trial registration and results disclosure support • Actively track and advise on potential impact of key regulatory reforms • Help them align with the evolving guidelines and regulations. • Regulatory and clinical experts deployed for managing Regulatory compliance. • Comprehensive disclosure reporting in a centralized, cost-effective manner. • Tracking, assessments, document management, summarization, release information to registries, registry query, and monthly site/status updates. • 100% accurately and compliance with minimal sponsor management • Scalable, flexible, cost-effective model

  10. REAL-WORLD CASE STUDY 9. Product Safety Services ~ 400 Narratives authored monthly 4+ Therapy Area ~ 75 - 100 Safety reconciliations monthly 100%on Quality & Timelines Outcomes Business Need Solution • Safety team has headcount pressures to manage Safety narratives and collation of information for CEC adjudication packets • Periodic safety data reconciliation and medical monitoring • Cost effective and flexible support required • Medical reviewers, writers and Medical monitors deployed • Author event-level, patient-level narratives; collate CEC adjudication packets • Medical review of the site reported data and CEC packets to identify safety queries • Reconciliation of all the safety data and line listing • Review core lab reports and imaging to identify any new potential events • Response to queries raised by independent clinical specialist during audit • ~ 200 narratives and 50 safety data reconciliation in the first 3 months • 100% compliance to timelines; <0.5 errors/page • Expansion to neurovascular, neurology and endovascular TA

  11. REAL-WORLD CASE STUDY 10. RMLs and IFUs 5+ Resources deployed within 3 weeks 8+ Geographies 250+ RMLs & IFUs created, updated and reviewed 100%on Timelines Outcomes Business Need Solution • Lack of consistency in IFUs across countries • Remediate and align IFUs • Create RMLs as a single source of truth for all future IFUs • Dedicated COE team of 3 labeling reviewers, 1 Medical reviewer, and QC • Comprehensive client training program • Partnered with multiple client teams to finalize approach • Developed database for the labels from the inception stage • RMLs for each of the product class developed; corresponding IFUs were also created and updated. • Scalable and time bound solution • Centralized label database maintained • Process and cost efficiencies

  12. Thank You FOLLOW US ON: info@indegene.com www.indegene.com

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