A Top 20 Pharma’s Journey to Perpetual Inspection Readiness
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Learn how a top 20 pharma fully automated management of investigator training records, saving time and money while ensuring inspection readiness.
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A Top 20 Pharma’s Journey to Perpetual Inspection Readiness
- 1. A Top 20 Pharma’s Journey to Perpetual Inspection Readiness
- 2. 2Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Sarah O’Hora Director Vault Clinical Rick Ward VP, Commercial Operations Leading Today’s Discussion
- 3. 3Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Discussion Agenda • Defining a few key terms: − “Comprehensive Training Records” − “Active TMF Management“ − “Inspection Readiness” • Top 20 Pharma: Journey to Perpetual Inspection Readiness − Centralizing Training Records Management − Automating Processes − Integrating with eTMF
- 4. Defining a Few Key Terms
- 6. 6Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 ICH GCP E6 (R2) Section 4.1: Investigator’s Qualification and Agreements • “The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).” Section 5.6: Investigator Selection • The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by training and experience and should have adequate resources (see 4.1, 4.2) to properly conduct the trial for which the investigator is selected. Section 5.18: Monitoring • In general there is a need for on-site monitoring, before, during, and after the trial; however in exceptional circumstances the sponsor may determine that central monitoring in conjunction with procedures such as investigators’ training and meetings, and extensive written guidance can assure appropriate conduct of the trial in accordance with GCP. • Particular attention should be given to those aspects that are not routine clinical practice and that require additional training.
- 7. 7Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 21 CFR Part 11 & 312 Selecting Investigators and Monitors • (a) Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug. Controls for Closed Systems • (i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks
- 8. 8Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 When does Training Take Place? Training of staff at sites activated after the live IM Standardized training in advance of formal Investigator Meeting(s) Training of site staff who did not attend the live IM Training conducted at live F2F (or virtual) Investigator Meetings Training conducted at site initiation visits Amendment training Training of new site staff (i.e., site staff turnover)
- 9. 9Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Types of Training Records Content Completion/ Certification Exemption Documentation Standardized (Non Protocol-specific) Training a a a Protocol-specific Training a a a Rater/Scale Training a a a Vendor/Systems Training a a a CRA Training at Site Initiation Visits a a a Amendment Training a a a
- 10. 10Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 The TMF Reference Model • Site Management Site Initiation Site Training Material − Training materials used to train the sites. Materials may be related to Electronic Data Capture (EDC), Interactive Response Technology (IRT), Rater training. (Also includes training done after site initiation) • Site Management Site Set-Up Site Staff Qualification Supporting Information − To document site staff qualifications not previously outlined on CVs. May include list of studies, publications, training certificates for specific examinations, ICH-GCP training, site GCP or trial licensure, medical licenses, Human Subjects Protection Training, etc. • Site Management Site Initiation Site Evidence of Training − To document completion of site training by relevant site personnel. Documentation includes attendance and certification for training delivered which may include Electronic Data Capture (EDC), Interactive Response Technology (IRT), Rater training, etc. • Trial Management Meetings Trial Team Training Material − Trial-relevant training materials , including use of specialized systems. • Trial Management Meetings Trial Team Evidence of Training − To document completion of trial team training, including certification or evidence of training (attendance sheets). Includes EDC training.
- 12. 12Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Passive vs. Active TMF Operating Models • Paper documents scanning • Study teams do not regularly access the TMF • TMF is not integrated with other clinical systems • No/few manual KPIs or metrics PASSIVE ACTIVE • Electronic documents managed in system • Sites, CROs, and sponsors have eTMF access • TMF is integrated with other eClinical systems • Real-time KPIs and metrics used for active management
- 13. 13Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Industry Moving to Active eTMF Industry is moving from a passive model where TMF is considered a cost center to an active model where TMF is a strategic asset 2.89 4.24 0 1 2 3 4 5 Industry average Average desired state Passive TMF “Managed State” Docs in system only after they are final and sent, scanned and processed Managing the process completely in the system as it is being executed Active TMF “Optimized State” Required Managed Effective Efficient Optimized n=50+ unique company evaluations Source: https://www.veevatmfmaturity.com
- 14. 14Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 TMF Compliance Challenge and Impact 31% of inspections over the past year resulted in extra days* DELAYS CAN RESULT IN $10s OF MILLIONS IN LOST REVENUE for a blockbuster product April 2014 MHRA updated definition of CRITICAL GCP inspection finding to include INCOMPLETE TMFs *Trial Master Files; Andy Fischer, MHRA, Senior GCP Inspector; MHRA GCP Symposium, September 2016
- 16. 16Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 What is Inspection Readiness? Preparation Activity Fire Drill! State of Being
- 17. 17Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the Regulations - MHRA SOP C006/11 “Reporting of GCP Inspections” 15Apr2014 Completeness
- 18. 18Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Contemporaneousness “TMF shall at all times contain the essential documents relating to that clinical trial”
- 19. Journey to Perpetual Inspection Readiness
- 20. 20Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Journey to Perpetual Inspection Readiness Before 2010: CoE Initiative — Improve Training Based on Feedback from Sites PROTOCOL AMENDMENT TRAINING MANUAL USER REQUESTED EXEMPTIONS LIVE INVESTIGATOR MEETING ATTENDANCE SIV & SITE VISITS NON-STANDARDIZED NPS TRACKING TRAINING VIA CD-ROM & DVD PAPER STUDY BINDERS MANUAL ASSET VERSION CONTROL TRAINING ASSETS MAILED/SHIPPED
- 21. 21Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Journey to Perpetual Inspection Readiness 2010: Launched Training Portal for Sponsor (NPS & PS Training) APPROX. 20 ACTIVE STUDIES BY EOY ON-DEMAND NPS TRAINING ON-DEMAND PS TRAINING LIVE INVESTIGATOR MEETING ATTENDANCE PROTOCOL AMENDMENT TRAINING SIV & SITE VISITS 2010 2011 2013 2015 2017 2018 USER REQUESTED EXEMPTIONS
- 22. 22Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Journey to Perpetual Inspection Readiness 2011: Cross Study, Cross Sponsor, & User Submitted Exemptions ON-DEMAND NPS TRAINING ON-DEMAND PS TRAINING APPROX. 50 ACTIVE STUDIES BY EOY LIVE INVESTIGATOR MEETING ATTENDANCE PROTOCOL AMENDMENT TRAINING SIV & SITE VISITS 2010 2011 2013 2015 20182017 USER REQUESTED EXEMPTIONS with CCD CROSS STUDY/SPONSOR EXEMPTIONS with CCD
- 23. 23Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Journey to Perpetual Inspection Readiness 2013: Paper Certificate of Attendance for Live IM Attendance PROTOCOL AMENDMENT TRAINING SIV & SITE VISITS ON-DEMAND NPS TRAINING ON-DEMAND PS TRAINING USER REQUESTED EXEMPTIONS with CCD CROSS STUDY/SPONSOR EXEMPTIONS with CCD LIVE INVESTIGATOR MEETING ATTENDANCE PAPER COA 2010 2011 2013 2015 20182017 APPROX. 100 ACTIVE STUDIES BY EOY
- 24. 24Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Journey to Perpetual Inspection Readiness 2015: TransCelerate SIP Integration ON-DEMAND NPS TRAINING ON-DEMAND PS TRAINING PROTOCOL AMENDMENT TRAININGS SIV & SITE VISITS LIVE INVESTIGATOR MEETING ATTENDANCE PAPER COA 2010 2011 2013 2015 20182017 TRANSCELERATE SIP INTEGRATION 1.0 USER REQUESTED EXEMPTIONS with CCD CROSS STUDY/SPONSOR EXEMPTIONS with CCD APPROX. 150 ACTIVE STUDIES BY EOY
- 25. 25Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Journey to Perpetual Inspection Readiness 2017: Introduced Interactive Tablet Solution to Live Meetings INVESTIGATORSPACE LIVE TABLET PROTOCOL AMENDMENT TRAINING SIV & SITE VISITS ON-DEMAND NPS TRAINING ON-DEMAND PS TRAINING LIVE INVESTIGATOR MEETING ATTENDANCE PAPER COA 2010 2011 2013 2015 20182017 USER REQUESTED EXEMPTIONS with CCD CROSS STUDY/SPONSOR EXEMPTIONS with CCD APPROX. 200 ACTIVE STUDIES BY EOY
- 26. 26Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Journey to Perpetual Inspection Readiness VEEVA VAULT INTEGRATION PROJECT 2010 2011 2013 2015 20182017 Justification/ROI Execution
- 27. 27Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Journey to Perpetual Inspection Readiness 2018: Introduced Mobile App for CRAs to Document Field Training ON-DEMAND NPS TRAINING ON-DEMAND PS TRAINING LIVE INVESTIGATOR MEETING ATTENDANCE INVESTIGATORSPACE MOBILE PILOT 2018 PROTOCOL AMENDMENT TRAINING SIV & SITE VISITS INVESTIGATORSPACE LIVE TABLET PAPER COA 2010 2011 2013 2015 20182017 USER REQUESTED EXEMPTIONS with CCD CROSS STUDY/SPONSOR EXEMPTIONS with CCD
- 28. 28Copyright © Veeva Systems 2018 Copyright © Trifecta Clinical 2018 Journey to Perpetual Inspection Readiness InvestigatorSpace Integrated with Veeva Vault eTMF
- 29. Any Questions
- 30. Sarah O’Hora — sarah.ohora@veeva.com Rick Ward — rick.ward@trifectaclinical.com
Editor's Notes
- < < < PLACEHOLDER WHILE WE WAIT FOR PRESENTATION TO BEGIN > > >
- SARAH: Introduction, Thank you, etc… RICK: Hello everyone – my name is Rick Ward and I head up Commercial Operations for Trifecta Clinical. Before we get started I’d like to note tha the views I share today are my own and not those of Trifecta Clinical. With that said, I’m very excited to be joining Sarah today to share what we believe will be a very interesting case study and hopefully provide everyone with some ideas they can bring back to their respective organizations.
- SARAH: Define a few key terms to level set the discussion… RICK: Share how Veeva and Trifecta partnered to build an integrated solution and helped a Top 20 Pharma company achieve, and perpetually maintain a state of Inspection Readiness.
- First…
- SARAH: x RICK: Key concept = There are well defined regulatory requirements to provide, and document, appropriate training of Investigators and Site Staff.
- SARAH: x
- RICK: Before we further define the types of “training records” which exist, let’s recognize that throughout the life cycle of a clinical trial, training takes place at different points in time, in various forms. And documentation (if it exists) is often decentralized in both paper and electronic formats (records from F2F IM, virtual IM logs, monitoring trip reports, etc.).
- RICK: So in addition to the various types of training, which include “general” or “standardized” training, sometimes referred to as “Non Protocol-Specific” training (things like ICH/GCP training, safety reporting, etc.), detailed training specific to the study protocol. And all too often we also have amendment training which could take place well after the study is launched. But in defining the term “Training Records” we need to keep in mind that this is not limited to the training content itself, but also compliance documentation that the training was completed by all required parties (often referred to as “training certification”), as well as documentation of any training exemptions granted. And again, with this documentation being generated throughout the study, and historically created in both paper and electronic format, often in a very decentralized model, it’s clear that being “Inspection Ready” with regards to Training Documentation can be quite a challenge.
- SARAH: x (good segue from “training documentation” to “active TMF Management”)
- SARAH: x
- SARAH: x
- SARAH: x
- SARAH: x
- RICK: Thank you Sarah, I think we’re all on the same page now regarding what it means to Actively Manage the Trial Master File. Before we begin telling the story of how a Top-20 Pharma …
- SARAH: x
- SARAH: x
- SARAH: x (will end with reference to “automating processes”)
- RICK: x
- RICK: Prior to Trifecta’s involvement, the sponsor was in a situation typical for that time. Investigator training processes and procedures were defined centrally, but conducted using assets that largely fell on individual study teams and site startup personnel to provide. Lack of a centralized training database could result in duplicative training being conducted by site personnel, and required sponsor teams spend a great deal of effort distributing the training assets. Gathering training records manually was also very time intensive. This situation was frustrating for both sites and sponsor teams alike, which is why investigator training was identified as a Center of Excellence initiative.
- RICK: Starting in 2010, Trifecta worked with the CoE to create an on-demand NPS training library. In addition, Trifecta would produce protocol specific training by capturing live investigator meetings for site personnel who could not attend. Training was launched using Trifecta’s first generation SaaS training portal, and the process of onboarding studies began. The core benefits of having single point of distribution, combined with centralized and normalized training history data provided immediate benefits to the sponsor and sites.
- RICK: In year two, as adoption accelerated, programs with a second study launching on the platform became more prevalent. Responding to site feedback, the sponsor asked if Trifecta could help sites working on multiple studies avoid duplicate training. The sponsor’s training leadership and Trifecta collaborated to create the Compliance & Certification Directory. The CCD is a sub-system that accurately identifies users across studies, then applies training equivalency rules to create study specific exemption documentation. The CCD would continue to grow: it currently processes nearly 60,000 individual exemptions per year.
- RICK: While online training processes were now efficient, reconciliation of live investigator training attendance continued to be labor intensive. In early 2013, Trifecta and the sponsor collaborated on the creation of the Certificate of Attendance (COA) system. COA had three major components; an Investigator Meeting Agenda creation system that provided consistent training topics naming across both online and live training events; a sign-in sheet generation system that used NPS data to create session sign in sheets (for example, a morning and afternoon session); and finally, the sign-in sheets themselves which include a quick-code containing all attendee information for that user and session. Once the sheet was signed, these code linked all elements to allow for the systematic reporting of live meeting training credit. Further, since live training and online training were now linked, novel use cases were now possible. For example, if a coordinator left a two-day IM early on the second day, they would automatically be sent a welcome email in order to complete the training topics provided during the session they missed
- RICK: As the sponsor is an early adopter of the Transclerate shared investigator portal, Trifecta worked with the sponsor and SIP stakeholders to complete the initial integration between Trifecta’s InvestigatorSpace training system and the Transclerate Shared Investigator Portal. Once a SIP user logs into the SIP using their Exostar credentials, they can click a SAML-based, single-sign-on link taking them seamlessly from the SIP into InvestigatorSpace. Once in InvestigatorSpace, training exemptions are processed, either from online sources or the COA system, then the users begin training. While taking training, the user’s training progress is sent back to the SIP in REAL TIME, ensuring training completion is always synchronized from InvestigatorSpace to the SIP.
- RICK: Building on the hybrid integration model of the paper COA, Trifecta was approached do create and tablet solution for live meetings that would provide an IS Live, an extension of InvestigatorSpace in the form of an interactive tablet solution, not only boosted the level of attendee engagement, but also allowed for the automated documentation of in-person training. NOTE: Coming back to 2017 in a moment!!!
- RICK: While Trifecta continued to automate the upstream training processes, inserting technology to capture data from training processes in near-realtime, it was not until the integration with Veeva Vault that the promise of Perpetual inspection readiness became truly possible. For the sponsor, the project had considerable ROI independent of this etc. etc. 248k x 3 min = x years of effort saved. From a project execution perspective, the sponsor provided all needed technical resourses, Veeva expert guidance and support, allowing the integration to be completed 12 days ahead of schedule. This year, in even though this pharma company was likely the industry leader in “Inspection Readiness”, at least with respect to training records, there was still a perceived “gap” of centrally tracking the training that takes place at SIVs as well as any other “field training” conducted by CRA’s. Thus, IS Mobile was developed to capture real-time documentation of any training discussions that take place at the site.
- RICK: Now that Live meeting attendance had been fully automated with IS Live, there was one final process, etc., - training conducted between a monitor or other field personnel and at the site location. While this will be piloted later this year, InvestigatorSpace mobile for Android and iOS allows for…etc. etc. This year, in even though this pharma company was likely the industry leader in “Inspection Readiness”, at least with respect to training records, there was still a perceived “gap” of centrally tracking the training that takes place at SIVs as well as any other “field training” conducted by CRA’s. Thus, IS Mobile was developed to capture real-time documentation of any training discussions that take place at the site.
- Single source of truth, summary. Path has been paved TWO PREPARED QUESTIONS:
- Staged Questions: Rick – “Is the integration between Trifecta’s system and Veeva Vault eTMF available to anyone and how long does it take to implement?” Sarah – “Do you provide “best practices” in how to structure your eTMF and what training documentation should be included?” Rick – “??? Sarah – “???
- SARAH: Just want to thank everyone again for sharing your time with us ……. RICK: Also, thank you all for the terrific questions. We did not get to every one, but we will follow up with folks directly on all the questions submitted. Additionally, if anyone has additional questions please feel free to reach out to either of us directly at any time. Thank you again!