Veeva Systems Inc. · NYSE:VEEV
Veeva Systems — Mulcahy Consulting — Investor Presentation (March 2014)
22 slides from Veeva Systems's investor presentation, March 2014
Slide 1: Designing Efficient Processes for TMF Content When Outsourcing Clinical Trials
DESIGNING EFFICIENT PROCESSES FOR Lisa Mulcahy Mulcahy TMF CONTENT Consulting, WHEN LLC OUTSOURCING CLINICAL TRIALS
Slide 2: Lisa Mulcahy
LISA MULCAHY Lisa Mulcahy ha s a 23 -yea r professiona l ca reer in the Pharmaceutical Research industr y. Content and Records Management independent consultant, particularly in the area of the tria l ma ster file. She is skilled in the assessment of client' s content a nd records mana gement TM F p
Slide 3: The Technology v. The Process
THE TECHNOLOGY V. THE PROCESS Much of the way that the content in Trial Master File is collected, created, and managed is contrary to our normal everyday way of thinking and working. Consumer rewards cards that connect personal data with usage and purchase data. We like getting some- thing for doi
Slide 4: The Technology v. The Process
THE TECHNOLOGY V. THE PROCESS For TMF collection, creation, and management many of us are still working in the… =
Slide 5: The "Old" TMF Paper-Based Process
THE “OLD” TMF PAPER-BASED PROCESS SPONSOR TO CRO OR SITE E P P TMF at CRO or ISF at Site P TMF at CRO or ISF at Site END HERE BEGIN HERE Up to 11 Steps!
Slide 6: Rethink Process
RETHINK PROCESS REDESIGN Redesign Rethink processes to enable sponsors, CROs, and sites to create and contribute efficiently to the TMF -- without paper or email attachments Create – Review - Approval – Collect - Submit Distribute - Consume – Acknowledge - Report
Slide 7: How Easy Can It Be?
HOW EASY CAN IT BE? USING TECHNOLOGY TO ITS FULLEST SITES eTMF PORTAL SPONSO R CRO / VENDOR S The technology is already available and will continue to advance Rethink the Process
Slide 8: So What's Holding Us Back?
SO WHAT’S HOLDING US BACK? OURSELVES!
Slide 9: Quick & Easy Targets
QUICK & EASY TARGETS Eliminate common, costly, and time-consuming pain points Define the full list of TMF content. Use TMF RM to align with industry – why be different? Evaluate each individually. Define purpose, usage/consumption Define movement through lifecycle Ask whether data ente
Slide 10: Quick & Easy Target: Signatures
QUICK & EASY TARGET: SIGNATURES Reduce internal signature requirements Only7 required per the ICH Guidelines Break ingrained habits. Is a signature required to establish accountability? Audit trials are functionally equivalent – automatically capture name, date, time If signatures are abso
Slide 11: Quick & Easy Target: Signatures
QUICK & EASY TARGET: SIGNATURES TMF CONTENT – SIGNATURE TMF CONTENT – SIGNATURE REQUIRED? REQUIRED? Notification to Investigators of Protocol signature page Safety Information (Sponsor and Investigator) Regulatory Submission Contract with Site Monitoring Visit Report Contract with Vendors Dose Escal
Slide 12: Quick & Easy Target: Scanning
QUICK & EASY TARGET: SCANNING Stop scanning electronically E created documents – manage them electronically Cost of inefficient resource utilization v. implementation of an 21CFRP11 P compliant repository such as eTMF If you have to scan, rethink the process… document by document Does every d
Slide 13: Quick & Easy Target: Email
QUICK & EASY TARGET: EMAIL Cut use of email and unofficial collaboration sites as document exchange vehicles. Establish process to exchange TMF content and electronic signature with CROs, vendors, and investigative sites electronically Use cloud-based eTMF with or without validated portal link
Slide 14: Quick & Easy Target: Shipping
QUICK & EASY TARGET: SHIPPING Stop sending paper TMF content by air $$$ to pay for transport $$$ and time for preparers to prepare $$$ and time for receivers to receive ROI easily calculated if transport P TMF at CRO costs are replaced with the “send” or ISF at button within an eTMF system
Slide 15: What Could One Rethought Process Look Like?
WHAT COULD ONE RETHOUGHT PROCESS LOOK LIKE? Rethink how a typically paper TMF document with a wet-ink signature component could be created and finalized? The Clinical Trial Agreement - critical to timelines SITES As-Is SPONSO R CRO Process E Creation Negotiation SITES SPONSO CRO P CRO R Wet-ink
Slide 16: How Easy Can It Be?
HOW EASY CAN IT BE? USING TECHNOLOGY TO ITS FULLEST SITES eTMF PORTAL SPONSO R CRO / VENDOR S Rethinking processes in which sponsors, CROs, and investigators contribute directly to the TMF
Slide 17: What Could Another Rethought Process Look Like?
WHAT COULD ANOTHER RETHOUGHT PROCESS LOOK LIKE? Rethink TMF content in terms of data sets The creation, collection, distribution of TMF content (data) would focus on the information exchanged and not doc creation/collection Assessing completeness of data instead of document presence Consider t
Slide 18: Critical Steps – Obstacles to Avoid
CRITICAL STEPS – OBSTACLES TO AVOID Company culture cannot be allowed to define the way you rethink your TMF management process. Help your 1 some company to break through their old ways of thinking to do . groundbreaking process work
Slide 19: Critical Steps – Obstacles to Avoid
CRITICAL STEPS – OBSTACLES TO AVOID Technology cannot provide the process. Technology supports the process 2 .
Slide 20: Critical Steps – Obstacles to Avoid
CRITICAL STEPS – OBSTACLES TO AVOID Engage the consumers of the TMF content when you rethink your process– at the sponsor, the CRO, and the investigative site. What do they actually need? 3 Like the electronic FDF, consumers might only need data…and not a document. . SPONSOR CRA PI/SI
Slide 21: In Summary
IN SUMMARY The technology to collect, create, manage, and exchange efficiently is here and evolving rapidly We must now rethink the human TMF management processes to best leverage the technology
Slide 22: Thank You
THANK YOU • To Veeva for the opportunity they have given me to be here with you today • To you for being here and being so engaged Contact info: MulcahyConsulting@comcast.net
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