1. INDEGENE Medical Devices Solutions
January, 2018

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

3. Documents developed/updated
REAL-WORLD CASE STUDY
2. Multi-geography Support For Clinical Evaluation Report Submission
End-to-end
Document management
40+
Documents developed/updated 12
Client SPOC managed
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
Business Need
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
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
Outcomes

4. Critical timeline 170 articles summarized CER submitted in 15 days
REAL-WORLD CASE STUDY
3. Fast Turn-around Clinical Evaluation Report for E.U. Submission in 15 Working Days
Critical timeline
170 articles summarized
CER submitted in 15 days
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
Business Need
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
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
Outcomes

5. Databases & guidelines reviewed Defined based on the analysis
REAL-WORLD CASE STUDY
4. Clinical Evidences For Risk-benefit Profile And Market Positioning
10+
Databases & guidelines reviewed
~ 400
Articles analysed
Regulatory strategy
Defined based on the analysis
Review clinical evidences and safety data to develop risk-benefit profile and market positioning
Review of literature across multiple databases and guideline recommendations.
Business Need
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
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
Outcomes

6. For first draft submission Client effort reduction on coordination
REAL-WORLD CASE STUDY
5. Publication Management
5 weeks
For first draft submission
20%
Client effort reduction on coordination
2.18
Impact factor
>4/5
Client expectations
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
Business Need
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
Solution
Review article successfully submitted and published
Outcomes

7. Client points of contact Documents developed/updated in a year
REAL-WORLD CASE STUDY
6. Scientific Communication 4
Client points of contact
40+
Documents developed/updated in a year
ZERO
Quality concerns
99.7% on
Timelines
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.
Business Need
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.
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
Outcomes

8. Full text articles reviewed Medical writers deployed
REAL-WORLD CASE STUDY
7. Evidence brief for Advisory Committee
Critical timelines of
10 days
~ 10,000
Articles screened
~ 500
Full text articles reviewed
10+
Medical writers deployed
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
Business Need
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)
Solution
Successfully submission to MEDCAC
~500 articles reviewed
End-to-end coordination and review
Successfully met the stringent timelines
Outcomes

9. Compliant - SOP, Quality, and Timelines
REAL-WORLD CASE STUDY
8. Clinical Trial Disclosure
50+
Trials
100%
Compliant - SOP, Quality, and Timelines
20+ Client POCs
3+ Years Engagement
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.
Business Need
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.
Solution
100% accurately and compliance with minimal sponsor management
Scalable, flexible, cost-effective model
Outcomes

10. Safety reconciliations monthly Narratives authored monthly
REAL-WORLD CASE STUDY
9. Product Safety Services 4+
Therapy Area ~
Safety reconciliations monthly
~ 400
Narratives authored monthly
100% on
Quality & Timelines
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
Business Need
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
Solution
~ 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
Outcomes

11. REAL-WORLD CASE STUDY 250+ 5+ 8+ 100% on Business Need Solution
10. RMLs and IFUs 8+
Geographies
250+
RMLs & IFUs created, updated and reviewed 5+
Resources deployed within 3 weeks
100% on
Timelines
Lack of consistency in IFUs across countries
Remediate and align IFUs
Create RMLs as a single source of truth for all future IFUs
Business Need
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
Solution
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
Outcomes

12. Thank You
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