Watch the video here: https://bit.ly/3oUi6Vg The clinical data team at Vertex asked themselves, how can we reduce our development timelines and costs—make things go faster, for less? Answering those questions set Vertex on a path to challenge themselves and their vendors to improve speed without sacrificing quality. As a result, they’re reducing database build times by as much as 50% and reliably lock data in 15-18 days. This webinar covers: * How Vertex reaches 80-90% compliance with sites entering data within 2 days of the event * Their #1 goal for transforming the UAT process * Their novel recommendation for when to go live * The technology strategy supporting their process improvements Who Will Benefit: * Clinical data executives * Heads of clinical * Heads of clinical research Meet Your Presenters: Vikas Gulati Senior Director of Clinical Data Management and Metrics, Vertex Pharmaceuticals Vikas Gulati has over 20 years’ experience focused on clinical data management, data standards and governance. He has led several global cross-functional teams to successful outcomes in Biotech/Pharma and CROs. He is currently the Global Head of Clinical Data Management at Vertex Pharmaceuticals, Inc. Richard Young Vice President, Vault EDC, Veeva Systems Richard Young has nearly 25 years of expertise in data management, clinical solutions, and advanced clinical strategies. At Veeva, Young is establishing Vault EDC as the leading solution for clinical data management. Michelle Harrison Associate Director of Clinical Data Management and Metrics, Vertex Michelle Harrison is currently working at Vertex Pharmaceutical in Boston Massachusetts as an Associate Director of Data Management. Prior to joining Vertex, she worked as a consultant for BioBridges. For 2 years there she consulted for a number of small Biotechs assisting with Vendor oversight and start up activities.

1. 1 ©2012 Vertex Pharmaceuticals Incorporated
Vikas Gulati, Senior Director
Clinical Data Management
Vertex Pharmaceuticals
1 ©2012 Vertex Pharmaceuticals Incorporated
©2019 Vertex Pharmaceuticals Incorporated
Transforming Data Management at Vertex
Richard Young, Vice President
Vault Clinical Data Management Systems
Veeva Systems
Michelle Harrison, Assoc. Director
Clinical Data Management
Vertex Pharmaceuticals

2. Where to Focus?
Business Processes that Affect DM Timelines
Areas We’re Doing Well
• Data entry
• Data cleaning & query
resolution
• Data lock – all sources
Areas to Improve
• Database build times
• UAT
• Use of standards

3. Data Collection – Strong Performance
Data lock in only
15-18 days
By 2nd visit,
80-90% of sites
enter data within
48 hours
~75% of sites
respond to queries
within 72 hours

4. How We Do It? – Sites First!
Carrot Not the Stick
• Seek consistency and simplicity
• No penalty clause in contract
• Learn what motivates them
Constant Communication and Feedback
• Meet with key site coordinators every 6 months
– Structured request for feedback, step-by-step
• Study-level engagement
– DM table at investigator meetings
– Early visibility, Q&A, and feedback with training database
– Seek input on completion guidelines
• Internal lessons learned every study – what worked, what
didn’t?
• DM space in weekly newsletter for sites

5. Advice for rapid database lock

6. ©2011 Vertex Pharmaceuticals Incorporated
Multi-layer Data Review
Site –
CCG; CRF
CRA
Monitoring and Remote Monitoring Plan
CDM
DM Manual Checks; Lab Checks (Conformance/Reporting)
CDM
Automated Edit Checks
CDM
Oversight Reports; Reconciliations; MM checks;
Vendor Oversight
CDM/SET
Cross Functional Team Review; Quality Surveillance; Metrics
SET
TFL Review Plan
SET
CSR Review Plan

7. Additional Advice for Rapid Data Lock
• Speed -- Begin reviewing ASAP (first patient screen)
– Must have live access to data
– Primary labs – automatic downloads
– Specialty labs – find labs in region to avoid shipping samples
• Focus on external data sources – often primary endpoint
– Get vendor confirmation they’ve locked their data
– Compare pre-lock transfer and post-lock transfer and do a proc
compare
• Consolidate vendors when possible
• Learn, revise, train, and re-use when you can
– Think how you want to review data, e.g. visit windows as edit
checks vs. listing review

8. Improving DM Startup Times

9. Data Management Startup Challenges
• Rising volume of clinical study data
• Increasing trial complexity
• Clinical timelines to site initiation shortening
• External data source integration and compatibility issues
• EDC limitations creating inefficiencies and extended handoffs
• Internal delays getting comments and feedback
Challenge ourselves to build faster, more efficiently,
and with quality using a risk-based approach.

10. Can’t compress a 12 week
timeline into 4 weeks.
Need to re-think your
processes and capabilities.

11. Opportunity: Rationalize the Edit Checks
Today:
Many checks rarely or never fire
Time is spent to define, program, and UAT
those checks
Recommend:
Remove those checks from the EDC
Use listings, j-review, other tools

12. Opportunity: Change Database Go-Live Criteria
Today:
Live @ 100% checks complete
At least one change-order per study
Recommend:
Live @ 90% checks complete
Updates as needed added to change-order

13. Opportunity: Risk-based Approach to UAT
Today:
UAT 100% of all edit checks
Recommend:
UAT 100% of primary and secondary end points
Risk-based UAT all other data

14. Opportunity: Change the Structure of the UAT Process
Current Ping-Pong Approach
Delay
Delay
Delay
Real-time feedback,
updates, confirmation,
documentation
One-time, Live,
Iterative Approach

15. Case Study:
Database Builds with
Veeva Vault CDMS
Study 1
8 weeks
40% Faster
than typical
13-14 weeks
Study 2
6 weeks
½
corporate target
of 12 weeks

16. Improve Use of Standards
Extensive library of standards
Strong governance around changes
Consistent enforcement of adopted standards
Deep knowledge of our standards in teams outside of DM
Standards training for new hires
Attempts to deviate from the standards introduce
unnecessary iterations and delay.

17. Partnering with Veeva

18. 18 ©2014 Vertex Pharmaceuticals Incorporated