EXECUTIVE SUMMARY 4TH TRIAL MASTER FILE SUMMIT. Join the Conversation Group: Good Clinical Records Management.

Transcription

1 EXECUTIVE SUMMARY 4TH TRIAL MASTER FILE SUMMIT Join the Conversation Group: Good Clinical Records Management

2 CONTENTS INTRODUCTION 3 PRESENTATIONS 4 RESOURCES FOR INFORMATION AND DISCUSSION 11

3 INTRODUCTION HERE S WHAT YOU MISSED AT EXL PHARMA S 4th TRIAL MASTER FILE SUMMIT If you weren t able to join us earlier this year, here is what you missed at ExL Pharma s 4th Trial Master File Summit With a focus on best practices to enhance TMF collection, monitoring, utilization, quality and archiving while remaining compliant for audits and inspection readiness, the only conference dedicated to paper and electronic TMF took place Jan , 2015 in Arlington, Virginia. The 2015 summit reviewed new and updated regulations from the MHRA, FDA, EMA and PMDA while sharing what investigators are looking for to ensure the TMF is in a continuous state of inspection readiness. Attendees also learned how to streamline paper TMF to optimize security and global accessibility, training techniques to ensure that staff keep the site running in an effective and compliant manner, and how to overcome hurdles to etmf implementation to reap the benefits of active workflows to support study conduct and metadata knowledge management. Further, the 4th annual event brought together professionals from pharmaceutical, biotech, medical device, and clinical research organizations with responsibilities in clinical operations, document management, regulatory affairs, TMF and etmf, data management, clinical document coordination, document and record specializations, clinical development, regulatory operations, knowledge management, global planning, clinical trial management, informatics and other areas. As the largest meeting dedicated to the improvement of etmf and paper TMF, the Trial Master File Summit explored optimizing a TMF process to improve TMF completeness, document, quality and efficiency. Following are session summaries and highlights to give you an idea of what you may have missed at our 4thTrial Master File Summit. 3

4 PRESENTATIONS Creating Cross-functional Teams for etmf Implementation, offered by Lisa Rakebrand of Janssen Research and Development, focused on the company s redesigned trial master file processes and technology. Janssen started the process by building organizational ownership with senior-level sponsorship and a steering committee as well as cross-functional collaboration. Next, they identified TMF content and processes, updating the TMF SOP as needed and familiarizing the organization with the TMF reference model alignment. System configuration includes document types and attributes, lifecycles and workflows, roles and security, reports, dashboards and templates. A TMF Center of Excellence was also initiated. Team-building takeaways include the following: communicate and be transparent as often as possible; tailor the message to the audience; identify your communication channels; be aware of organizational structural changes; leverage technology; be honest with your team; delegate; and have some fun along the way. Finally, empower the team with the ability to make decisions and move the transformation forward. Leverage etmf to Improve Monitoring and Inspection Readiness through Advanced Rendering, delivered by John Hanrahan of Adlib, explained that advanced rendering automates the conversion of corporate documents and intellectual property into accessible and usable digital assets that streamline document-intensive business processes. This improves collaboration, increases overall efficiency, mitigates risk and reduces costs. Convert, combine and enhance are the keys to creating the perfect, compliant PDFs. Likewise, capture, process and archive involves content discovery and clean-up, migration to ECM repository and converting s to PDF. Document attributes can influence and impact compliance, in particular, fidelity, navigability, findability and security. A special PDF checker can check any PDF for compliance issues, automating manual publishing quality control steps, identifying pages that require attention and saving the report as a non-pdf ECM rendition, among other features. 4

5 Shannon Cooke of TransPerfect shared ETMF and Site Archiving: Perspective, Case Studies, Lessons Learned with a wealth of solutions for going paperless. Pharma and drug development groups are becoming more comfortable with e-submissions and etmf, supported by business drivers such as increased employee and site performance, decrease in study start-up timeliness, increased transparency, reduction in hard costs and increased study collaboration. THE BUSINESS DRIVERS BEHIND IT.... Key etmf site benefits include workflow efficiencies, streamline versus redundancy, transparency and assurances, and access to information. Connecting with patients is also important sites are filled with busy people and increasing efficiency and decreasing stress is a significant benefit. This can include e-submission via portals, dashboards of relevant information, auto-generated notifications/task management, and greater transparency and visibility. The main reported concern is that the site staff doesn t have the technical proficiency to use the etmf efficiently. It s important to select an integrated platform that connects feasibility, study start-up and etmf and to ensure that it can share data across the process steps. Practical site tips include: keep updated e-versions of all frequently requested documents, be proactive and continuing education for site staff. For sponsors, get started early and stay ahead of the curve while offering continuing education for staff. Sukh Chugh of Allergen presented Building an Investigator Portal from the Ground up: Decisions, Pitfalls and Lessons (Template Autofill) CONGA Learned, in which Allergan decided to build its own investor portal. They wanted to articulate long-term vision, develop DOCUSIGN (21CFR Part 11) a catalog of needs, prioritize areas of functionality, contract OKTA (Gatekeeper) External Interface Internal Interface external vendors to assist, manage culture change, pilot to SALESFORCE.COM show early success, incorporate lessons learned and reinforce (WebService) the vision. The prioritized areas of functionality were single sign-on, training system integration, CTMS integration, document repository integration, study start-up document exchange and digital signature. The solution was an investigator portal a web-based tool that would act as a single source for clinical trial interactions between Allergan and clinical sites; it was built on SalesForce Platform, combined with various partner capabilities and resulted in extensive efficiencies. Lessons learned centered around international requirements, data accuracy, scale to efficiency, change management, site adoption, ongoing senior management support, UI for internal users and the need to watch for additional costs. 5

6 Jason Methia of Veeva helped attendees with Establishing Processes and Controls to Ensure an Inspection-Ready Significant Opportunity for the Industry Only half of electronic models use etmfs with advanced process management TMF Every Day, noting that 35 percent of inspections over etmf Application N/A, only use paper the past year resulted in extra days of inspection based on 13% 13% difficulties with TMFs being complete and readily available. The paper legacy holds back productivity and inspection Content mgmt. 26% Local file system 30% system readiness while multiple divergent systems impact compliance. All of this means that there is significant opportunity for 18% the industry: only half of electronic models use etmfs with Cloud file share Source: Veeva 2015 Paperless TMF Survey What type of etmf solution did you most recently use? (n=135, Q.9) Sponsor company responses only. advanced process management. The TMF maturity model for life sciences incorporates TMF strategy, infrastructure, process alignment, collaboration, compliance and governance. Technology, then, can bring together sponsors, sites and CROs. etmfs offer cost savings, improved audits and improved SOP compliance. Creating an inspection-ready compliance model involves three keys stages: 1) evaluate all aspects of TMF operations; 2) push towards single source of truth environment; and 3) shift from passive etmf archive to active etmf application Veeva Systems Company Confidential veeva.com 8 A panel discussion on how to Create, Utilize and Enhance Your TMF Process through Metrics Implementation was hosted by Linda Sullivan of Metrics Champion Consortium, Vinita Leslie of Biogen Idec, Terri Thomasma of Abbvie, Ivan Walrath of Pfizer and Nancy Snowden of NGCG. Each panel member shared brief information about their companies and roles, including details on understanding the process improvement metrics has on YMF collection and monitoring and the importance of implementing metrics in reforming key performance indicators. For example, Biogen Idec has a team called KRIS: Knowledge, Records and Information Strategies. This global team within regulatory affairs focuses on knowledge management, records and information management, collaboration and best practices. They use two sets of metrics study centric and etmf centric. The company provides reports with consistent information, focuses on areas of non-compliance and limits metrication to a level sufficient to demonstrate compliance and then handles non-compliance on a case-by-case basis. Furthermore, NCGS focuses on quality processes, etmf and support services with enterprisewide etmf owners and team leads as well as well-defined QC/QA processes end to end. All members encouraged the implementation of a global metrics and monitoring platform. 6

7 etmf Migrations: Key Considerations in Determining the Right Approach for Your Organization from Kathie Clark of Wingspan Technologies focused on moving beyond TMFs stored in a vanilla SharePoint or Documentum system and defining goals of the migration. What can go wrong? Scope creep, too much user time, missing information, poor return on investment and more. Understanding the business goals of the etmf migration helps companies make the right choices when presented with difficult decisions; organizations have more latitude in defining the scope of their etmf migrations than with other migrations. A set of specific requirements and a project plan will help promote scope control and deliver results on time. The quality of the document content and metadata for migrated documents depends on the quality control practices that were in place for the legacy systems. If the level of confidence in content and metadata is not high, further quality control may be justified and needed before documents are made available for use in the etmf. As with most aspects of migration, a risk-based approach is recommended. After migration decisions are made, a final review of the cost and benefits should be done to identify decisions that may have inadvertently added significant scope and cost to the migration effort. A case study on Understanding the Latest Regulations and Guidance and Preparing for Inspection, delivered by Ivan Walrath of Pfizer, explored trends in regulations and discussed A simple view into the TMF; simple, hands on accountability the TMF as critical to regulatory and legal compliance. The Document Owners etmf Repositories future approach may involve remote access for inspectors which could reduce the number of days on site as well as the costs associated with regulatory inspections. Meeting Document Owners etmf Repository regulatory requirements involves the documentation necessary to reconstruct the conduct of trials in accordance with standards of ICH, GCP and using the DIA TMF reference model; 9 Pfizer developed a comprehensive master TMF document list to meet specific European standards. An interactive metrics function allows users to monitor outcomes and take control of the TMF process three measures (TMF document quality, completeness and timeliness) help to ensure the highest standards in the TMF. The company also sets standards for transparency and full disclosure. A Readily Accessible Interface for Regulatory Inspections Setting standards for transparency and full disclosure Before Today Inspectors and Pfizer Colleagues Inspectors and Pfizer Colleagues 9 7

8 Karen Roy of Phlex offered the latest information on The Trial Master File Reference Model: The Road to Version 3, noting that the TMF Reference Model was created through a group of Drug Information Association volunteers with about 350 contributors from about 200 companies. Goals of the reference model are: standard contents, standard naming, standard structure and standard metadata, all intended to bring therapies to market faster. In a survey, most companies have used it and the majority have modified it somewhat. } 104 responses Challenges of moving to version 3 are overall coordinator time, zone lead time, zone members engagement, collating feedback in a standardized format, standardizing review process per zone and collections of documents vs. single documents against an artifact. There are 11 zones, each with a team leader. Inputs and deliverables include consolidated public feedback for each zone and responses to that feedback, applicable cross-zone issues for resolution, marked-up zone content and clean content. A technical committee also works on the reference model, making it usable and understandable in more formats. Finally, a communication team provides regular updates and manages publications and social media. Develop an etmf Mentality by Innovating Paper TMF Processes from David Benedit and Eric Rubinson of Actavis shared the Forest Research Institute s approach for creating an etmf mindset by integrating the look and feel of etmf into current paper processes, including case studies of six process improvements. Business objectives for embracing etmf include the desire for electronic records, virtual processing and remote reconciliation, electronic approvals and submission, elimination of redundancies and real-time transparent operations. A phased and incremental approach involved collaboration and pilot studies as proof of concept. Centralized transmittal tracking led to notable benefits, such as predefined metadata and reduction in redundancies. A centralized mail depot significantly strengthened the security, oversight and throughput efficiency of paper records bound for the TMF. They also developed a SharePoint tool that allows regional site monitors to submit approved visit reports electronically and track archival status in the TMF; this reduces shipping administration/costs, takes less time than completing an air bill, turns transmittal form details into a real-time searchable table of contents, builds on naming conventions and metadata standards for future etmf, and the platform is etmf ready with appropriate validation. It looks and feels like etmf but facilitates the current paper process. Continued results include significant savings and improved process satisfaction. 8

9 A Boehringer-Ingelheim case study on How to Achieve the Best Results in Document Submission from a CRO was shared by Fabio Rodrigues, clinical manager of the company s Medical division. His key suggestions were to work regionally with CROs in LATAM and discuss expectations; identify and develop strategic KPIs; and increase communication through executive meetings with upper management from CRO to share results. The company outsources most clinical trials to CROs in LATAM and needed to evolve process flows to save time and money. Measurement leads to control and then to improvement and KPIs were established for metrics: KPI1 with etmf monthly document submission; KPI2 was etmf quality check; and KPI3 was etmf completeness. Building a partnership involves following up with the CROs activity on a regular basis and developing an etmf action plan. Other lessons include: make expectations clear to everyone; establish easy metrics to measure because they encourage the CRO to achieve the best results; keep track of the work; and collaborate for success. Effective CRO Oversight to Ensure Compliance and an Up-to-Date TMF from Wendy Trimboli of Eisai noted that effective communication is one of the chief keys to maximizing efficiencies, quality and oversight. She suggested interacting with one point of contact at the CRO and conducting quarterly oversight meetings. It is also important to manage the flow of trial information between sponsor and CRO and to utilize a standard list of SOPs. Automated processes, system integration, a complete TMF, quality control reviews, metrics and a focus on continuous improvement are additional keys to success. Issues and lessons learned include: many issues are reported from multiple sources so the company created an issues log spreadsheet to identify issues, trends, source, QC check and more; there is a strong need for transparency so queried documents are now viewable within the system and shared with CRO contacts; continuous improvement assessments will lead to process improvements. 9

10 A case study on How to Maintain a Compliant TMF across Multiple Global Sites was shared by Andrew Waite of Amgen, who encouraged organizations to stay organized during set-up, maintenance and archiving for outsourced studies while establishing communication with international clinical sites. The Amgen case study involved multiple Ph3 studies full service outsourced to CROs, inclusive of TMF management. Challenges were that CRO SOPs and the process utilized for study conduct did not fully match Amgen s TMF structure and process and TMF files were decentralized management. Amgen introduced a new etmf solution where the files were available online 24/7 globally for non-outsourced studies and an expectation was set that all TMF documents would be accessible anywhere and anytime now program managers wanted the same access for outsourced programs. A decision was made to bring in-house all outsourced TMFs and place them into the new Amgen etmf system. Top-notch organization and communication helped the company navigate set-up as well as cultural, lingual and time-zone differences. In conclusion, he stressed the importance of defining the TMF process upfront to ensure accountability and reminded audience members that the TMF world continues to evolve. He finished by defining TMF as Too Much Fun. So You re the Little Guy: Achieve TMF Inspection Readiness, which was presented by Curran Murphy of Cerulean Pharma, stated that even though you re small/a start-up, you can achieve TMF inspection readiness. It is all about the planning: Know your organizational structure, define TMF structure and process, and execute with internal quality oversight. Getting started entails assembling a TMF sub team with good facilitation, timelines and ongoing progress reporting. This team will define organizational structure, TMF gaps and TMF structure a quality representative is also part of this process. TMF process tools for the small company include the following: a TMF plan template, TMF structure set-up checklist, TMF structure change checklist, TMF inventory template, periodic quality check template, close-out quality check template and authorization to ship TMF. Finally, periodic quality checks are the best insurance for inspection readiness. This was a great conference overall and incredibly informative - Associate Director, SSU Regulatory, INC Research Fantastic speakers and session - TMF Records Management, ELI LILLY Especially liked the actual case studies and I appreciate when vendors present new tools and technology. - Senior CTA Clinical Systems, ALKERMES Excellent overview of events from the past year and why we are here... valuable lessons learned. - Senior Project Manager, GSK 10

11 RESOURCES FOR INFORMATION AND DISCUSSION THE INDUSTRY S ONLY CONFERENCE SERIES DEDICATED TO IMPROVING PAPER AND ELECTRONIC TMF MANAGEMENT 5TH TRIAL MASTER FILE SUMMIT Develop a TMF process in order to ensure a complete, compliant, high-quality and inspection-ready TMF January 20-22, 2016 / The Westin Arlington Gateway / Arlington, VA At ExL Pharma s 5th Trial Master File Summit, TMF experts will discuss best practices for developing, managing and monitoring a TMF process that is regulatory compliant for audits and inspections. TMF process owners, quality assurance, clinical, regulatory and information technology professionals who are responsible for Trial Master Files will share insights and best practices to facilitate successful TMF management. THE 2016 TMF SUMMIT FEATURES: 20 educational sessions covering all aspects of paper and electronic TMF filings 6 case study presentations from Amgen, Bayer, BioMarin, Boehringer Ingelheim, Eisai and Janssen A TMF workshop for newcomers, which introduces the Trial Master File and the many challenges that TMF professionals face A 5-hour interactive TMF training seminar on the keys to successful TMF management 9+ hours of networking with 175+ TMF professionals An engaging panel session on trends, the preparation of and expectations for a TMF inspection 14+ hours of educational sessions that will provide you with best practices, lessons learned and case studies Updates on the DIA Reference Model Version 3.0, TransCelerate s eisf and the MCC s working group For more information or to register for the 2016 event please visit: If you are interested in sponsorship or exhibition opportunities please contact Eric Morrin at or emorrin@exlevents.com. 11

12 RESOURCES FOR INFORMATION AND DISCUSSION Website: Website: True e-integration. A single portal. NCGS, Incorporated, an international CRO, leverages integrated technology to mitigate risk and provide agile management. SERVICES: Trial, Grants, and Data Management; etmf, CTMS, EDC, epro, IWRS, RBM; Full or Strategic Sourcing; Trial Rescue. RESULTS: Approval or expanded labeling of 31 products in 31 years of operation; Zero 483s. WBENC Diversity Certified. Website: Phlexglobal are the Trial Master File (TMF) Experts, and pioneers in the provision of innovative, flexible and technology-enabled TMF solutions & services. A specialist provider of electronic Trial Master File (etmf) solutions and other support services to the global clinical research market; we offer a unique combination of technology, quality and services that deliver a range of flexible, targeted solutions to the life science industry. Website: Rho, a full-service CRO, has been a trusted partner to leading pharmaceutical, biotechnology and medical device companies as well as academic and government organizations for 30 years. Our commitment to excellence, innovative technologies and therapeutic expertise accelerate time to market and lead to an exceptional customer experience. Website: 12

13 RESOURCES FOR INFORMATION AND DISCUSSION TransPerfect provides a collaborative Web-based platform for study start-up and etmf that enables sponsors, CROs, IRBs, central laboratories, and other vendors to maintain and update clinical trial documentation in a secure online environment. TransPerfect s Life Sciences division is dedicated to working with clients on a global, collaborative level, supporting a wide range of requirements including product licensing and alliance management, endpoint adjudication, etmf review/reconciliation, and pharmacovigilance. Website: Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 300 customers, ranging from the world s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit Global life sciences companies worldwide rely on Veeva Vault etmf to managing their TMF documents and processes. Designed specifically for the life sciences industry, Vault etmf not only lets you create, exchange, and update all of your trial documents within one secure, cloud-based application, it also supports your trial processes across all of your partners. To learn more about Vault etmf, visit: Website: W ingspan Technology, Inc. Wingspan Technology, Inc. provides an industry-leading cloud-based etmf to both sponsors and CROs. etmf provides a modern user experience modeled on commercial websites such as Amazon and ebay dramatically reducing user training time and frustration. Our dashboards and metrics provide unprecedented insight into the status and health of ongoing trials. Simple processes for uploading and checking documents greatly decrease both the time needed for these processes and the possibility of error. Our robust and scalable infrastructure has a proven track record of supporting users in more than 60 countries worldwide in processing up to 10,000 documents a day for hundreds of trials. Website: 13