1. 1. eTMF Tricia McQuarrie Clinical Operations Manager
2. 2. Who is Arivis? Arivis has been providing regulatory and clinical infrastructure since 2005 Many Firsts First cloud-based Regulatory Document Management System First cloud-based Regulatory Submission Management System First ever integrated Document, Project, and Submission Management System First ever regulatory content planning system First ever cloud-based regulatory platform First Part 11 compliant solution in the cloud (since 2005) Solution used on every continent and virtually every country The leader in Regulatory Information Management (RIM) Offices in US (Phoenix) and Germany (Munich Area) Garter recognized SaaS provider for FDA Regulated Industries Arivis, Inc., Confidential
3. 3. US Headquarters Phoenix AZ Global Headquarters Munich Germany Development Center Rostok Germany Global Organization Arivis, Inc., Confidential
4. 4. Who Uses Arivis? Arivis, Inc., Confidential
5. 5. What you do is incredibly important. It is also very challenging. Arivis, Inc., Confidential
6. 6. That is why you need ONE, easy-to-use cloud-based system for one and all of your users needs. Arivis, Inc., Confidential
7. 7. That is why Arivis has introduced Clireo to support Clinical eTMF Commercial eMPM Regulatory eDMS Regulatory Submissions eCTD (+) With secure, global access with single sign-on. Across all of your internal and external users. Arivis, Inc., Confidential
8. 8. And we have been doing this a while. Our 21 CFR Part 11 cloud technology has been serving clients since 2007. Arivis, Inc., Confidential
9. 9. eDMS Electronic Document Management eTMF Electronic Trial Master File VDR Virtual Data Room PM Project Management Submission s eCTD & Paper Regulatory Submissions eMPM Electronic Management of Promotional Materials Part 11 Compliant Audit Trail User Configurable Administratio n Claims-based authentication supporting AzureAD, AD, Windows Live Bulk Document Handling Functionality Role Based, Group & Individual Security Digital and Electronic Signature Support Platform & Web-browser Independent Lucene Search and Global Access Project rather than user based licensing Over 300 regulatory templates in Word and XML. Configurable storage and support for eDMS and eTMF models Versioning, Check-in / out, Signatures, Renditions, Context Metadata Web-based component authoring Workflow and Notifications Secure web- browser viewing Graphical and Exportable Reporting HIPAA compliant BAA Multiple geographic copies Software & Hardware monitoring NSProtect Security Independently audited facilities and equipment CFR 21 Part 11 Compliance Security Best Practices Upgrade on demand Flexible and unlimited data storage with 6x data replication
10. 10. eTMF and Arivis Professional Services
11. 11. What is a TMF? Traditionally kept as a set of binders, the Trial Master File (TMF) includes an array of document types ranging from Site Contracts to Clinical Study Reports with numerous documents of each type, often resulting in a total collection of thousands of documents in each TMF. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. ICH GCP E6 (R1) Arivis, Inc., Confidential
12. 12. Essential Documents Documents which individually and collectively permit evaluation of the conduct of a trial and quality of the data produced Usually the documents are audited by the sponsors independent audit function and inspected by Health Authorities as part of the process to confirm the validity of the trial conduct and the integrity of the data collected. Arivis, Inc., Confidential
13. 13. Pre-site selection Investigators Brochure Protocol Informed consent CRF Site Selection Confidentiality agreement Pre-study visit (investigator selection,site suitability,items concerning overall study conduct) Regulatory Notification of IND # or CTA approval Registration in Clinicaltrials.gov IRB/IEC Submission Site Set-up Protocol signature page PI & Sub-I cv Form FDA 1572 Financial Disclosure Monitoring Trial initiation monitoring report Site training documentation Monitoring visit report Protocol deviations Investigational Product Instructions for handling Accountability Documentation Safety Safety Management plan SAE reports Pharmacovigilance Database Line Listing Centralized Testing Facility Normal ranges Certificate of accreditation Third party Oversight Confidentiality Agreement Contractual Agreement Data Management Data Mgmt. Plan CRFs EDC Statistical Analysis SAP Randomization Plan Datasets Programs Clinical Study Report Essential Documents Collected During a Clinical Trial Arivis, Inc., Confidential
14. 14. Challenges The Life Science industry is facing pressure to cut costs while facing increasingly challenging regulatory requirements- which have increased the cost. With more clinical studies being conducted globally, paper TMFs are becoming more of a challenge as file numbers increase. Arivis, Inc., Confidential
15. 15. What is an eTMF System? An eTMF system is the application of a 21 CFR 11 compliant electronic document management system to automate time consuming error-prone manual paper-based processes. Documents and content are stored centrally on a computer server cloud versus in binders. Secure internet connection that can be accessed globally with auditable security Arivis, Inc., Confidential
16. 16. Benefits of an eTMF Arivis, Inc., Confidential
17. 17. eTMF Cost Savings Item N Frequency Unit Cost Total Year 1 Total Year 2 Total Cost for 2 Years Electronic TMF Setup and implementation 1 1 $ 20,000.00 $ 20,000.00 $ - $ 20,000.00 Software License and hosting 1 12 $ 2,400.00 $ 28,800.00 $ 28,800.00 $ 57,600.00 Personnel .5 FTE 1040 $ 20.00 $ 20,800.00 $ 20,800.00 $ 41,600.00 Yearly Total $ 48,800.00 $ 18,000.00 Total Cost of eTMF for 2 Years $ 119,200.00 Paper TMF CRO/Sponsor Document Transfers (200 documents per month) 40 40 $ 50.00 $ 80,000.00 $ 80,000.00 $ 160,000.00 Fire Proof Filing Cabinets 15 1 $ 2,000.00 $ 30,000.00 $ - $ 30,000.00 Off-site Storage (7 years) 12 7 $ 75.00 $ 6,300.00 $ - $ 4,500.00 Personnel 1 FTE 2080 $ 20.00 $ 41,600.00 $ 41,600.00 $ 83,200.00 Yearly Total $ 157,900.00 $ 121,600.00 Total Cost of Paper TMF for 2 Years $ 277,700.00 Total amount saved $ 158,500.00 Return On Investment 154% Arivis, Inc., Confidential
18. 18. Benefits of Applying the DIA Reference Model to TMF Trial master files should be established at the beginning of the trial, both at the investigator/institutions site and at the sponsors office. A final close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files. Arivis, Inc., Confidential
19. 19. Flexible and unlimited data storage with 6x data replication Project Management Project rather than user based licensing Support for Industry Standards Version Control (Check-in/out) Complex Metadata Workflow and Notifications Email Document Link View Documents in Web-browser Easy Administration Bulk Upload Role Based Permissions Quick and Simple Configuration and Start-up Google-like Search Document Storage & Classification Search, retrieval & distribution Authoring & review, collaboration Global availability 24/7 Single sign-on 21-CFR-Part 11 compliant Standard but customizable hierarchy Metrics and Reporting VDR Business Development EDMS Regulatory, Nonclinical, CMC eTMF Clinical Trial Documents Submissions Regulatory Submissions in eCTD format eMPM Post- marketing Multiple copies across the globe NSProtect Security HIPAA Compliant BAA Open API Software and hardware monitoring Upgrade on demand Claims-based authentication Document Encryption Services Arivis, Inc., Confidential
20. 20. What is Clireo? Clireo is: Electronic Document Management Compliant with the DIA EDM Reference Model and ad hoc models Context Sensitive Metadata Automated PDF Renditions Digital and Electronic Submissions Part 11 Compliance Clireo is: Electronic (eCTD, NEES) and Paper (510k, PMA) Submission Comprehensive submission management and tracking system Globally compliant Support for IND, NDA, MAA, BLA, 510k, PMA to name a few Clireo is: Electronic Trial Master File Comprehensive Software and Service enabling the Trial Master File Compliant with the DIA Trial Master File Reference Model Arivis, Inc., Confidential
21. 21. What is Clireo? Clireo is: Project Management and Planning Complete project management Automated rollup of document completeness Clireo is: Virtual Data Room Clireo is: Component Authoring Clireo is: Comprehensive Reporting Mobile iOS application for tracking project status in real-time Comprehensive document, project, clinical and regulatory reports Export in multiple formats Clireo is: Regulatory Tracking Arivis, Inc., Confidential
22. 22. How can Clireo eTMF help me? Assign access and maintain control of Sites, Vendors, and Auditors for content. Eliminate CRA need to reconcile the Investigator Site File against the Sponsor TMF. Part 21 CFR 11 Digital signatures allow for faster turn around time on documents. Ability to disseminate new information to users that the information is relevant to. Vendors and Sites can upload documentation and data directly into Clireo. Unlimited storage capacity assures that all documentation can be held in one location. Arivis, Inc., Confidential
23. 23. How can Clireo eTMF help me? No additional hardware required to implement Dashboard reports on the status of sites and documents to easily identify missing or lagging information. Protect documents against unauthorized modification. Supports single or multiple file uploads with single screen metadata tagging. Centralized Documentation-Access from Anywhere. Resolve document issues faster. Ability to search documents in many ways. Dramatic Reduction in the need to print, scan, and store multiple copies in several locations. Link documents together to create a complete document package. Arivis, Inc., Confidential
24. 24. The integrated HTML 5 viewer securely lets users view document content on any platform or browser View Documents Anywhereon Any Device Arivis, Inc., Confidential
25. 25. Site eTMF must be under the control of the PI while secure and selective access granted to the sponsor. The sponsor eTMF is under the sponsors control. Single Sign-On into your own System and Partners Systems Arivis, Inc., Confidential
26. 26. Clireo Document Management Clireo offers brilliant end-user functionality In addition, Clireo offers a set of advanced back-end tools to support advanced business processes: Bulk loading of documents and all other file types Bulk loading of electronic submissions Bulk loading of submissions + their associated documents simultaneously Automated / on-going document loading from FTP and sFTP sites Comparison of documents classified vs documents still in holding zone Bulk document / data extraction and download Project deployment using Microsoft Project files honoring all dates, structures, and relationships Arivis, Inc., Confidential
27. 27. eTMF your Clinical Document Source Staging area and support for FTP document transmittal eTMF specific reporting DIA eTMF Reference Model Support both in hierarchy and metadata Global Access Inspector Portal cGCP compliant access and ownership for site documents Placeholder documents with expected dates eTMF specific workflows and statuses Arivis, Inc., Confidential
28. 28. Rich Document Management Features Workflow (parallel and sequential) Electronic Signatures PDF Rendering Digital signatures Document cross linking Document relationships tracking Project Management Collaborative Review Version and document compare Version control Library services Viewing without downloading (HTML5) Detailed permissions and group support Context sensitive metadata Arivis, Inc., Confidential
29. 29. We have found that users want better oversight, better control, and more functionality. Clireo lets you do more in one screen than other applications Do More in One Screen Arivis, Inc., Confidential
30. 30. Dynamic quick views of always on information. Plus deep drill down with comprehensive industry and application specific reports Better Insight: Actionable Information at your Fingertips Arivis, Inc., Confidential
31. 31. Everyone can be given access. Your eTMF documents can link to your eDMS, and your eDMS document can link to your submission. Eliminating Boundaries across Companies and Departments Arivis, Inc., Confidential
32. 32. Workflows, project structures, reference models, metadata, and product features working together to support eTMF, eCTD, eDMS, eMPM, and VDR yet an application flexible enough to support all of your needs. Support for Specific Life Science Business Processes Arivis, Inc., Confidential
33. 33. Arivis Professional Services The Professional Services Group at Arivis provides premier strategic and tactical services to fit your specific regulatory needs with individual attention to detail. The continuum of bringing a Life Science product from concept to market is a long, complex endeavor which requires many experts in a variety of fields. During the journey, years worth of data and documents are created. Coordinating all of the stages, resources, and information is critical during the process. Keeping an eye on all of the moving parts in an ever more complicated world is even more critical for decision makers. Arivis has the expertise and solutions that meet the needs of Pharmaceutical, Medical Device, Biotech, Combination Product and Diagnostics companies, regardless of your size or state of your business. Our team provides complete regulatory information management and tracking solutions to manage your product information worldwide. The end result is a seamless process through the whole life cycle of your projects. Arivis, Inc., Confidential
34. 34. Arivis Professional Services Collaboration is the key to our success. From initial project initiation and throughout the engagement, we bond with our clients and work together to reach strategic objectives. We will share our knowledge, guide you through the complicated regulatory landscape and provide skill-building assistance to help you become self-sufficient at managing your projects. Arivis, Inc., Confidential
35. 35. Arivis Professional Services Do you currently maintain paper trial master files (TMF)? Do you have an unsecured shared drive containing important Regulatory documentation? Arivis Professional Services Group can help you prepare and organize documents to be used in due diligence activities, regulatory submissions, and Quality Assurance inspections/audits. We can help you to scan, index, and archive documents utilizing industry best practices and reference models. We have extensive experience in clinical electronic trial master files and document management systems and can host these cloud-based systems for you so you and your team can have access 24/7. Arivis Professional Services Group, enabled by best- in-class technologies, enable simplified document management and maintenance.Arivis, Inc., Confidential
36. 36. Experience Execution is the name of the game and it is achieved through action. The Arivis Professional Services Group has recognized expertise in integrating compliance, business processes, and technology into innovative and practical IT solutions for Regulatory submissions to global health authorities and maintains deep knowledge and understanding of the submission process and regulatory requirements. Arivis, Inc., Confidential
37. 37. Quality Achieving service excellence is one of our main goals at Arivis. We pride ourselves on maintaining a Professional Services Quality Management System that helps us to achieve consistent business processes and drive measurable, cost-saving performance improvements. The quality management system not only provides a structure and framework, it also ensures security as well as an audit mechanism that enforces corrective action. Continuous improvement happens within all processes in a systematic manner. Arivis, Inc., Confidential
38. 38. Responsiveness You've seen it, felt it, and experienced it: the pace of your business has accelerated. You're being asked to do more with less. You're experiencing more budget pressures, more regulatory pressures, and more competitive pressures. If only you could turn to a business partner for innovative solutions to all of these challenges. If only Regulatory Operations and Project Management professionals were available whenever you need them. Well, you can and they are! When you're feeling the strain of limited resources, immediate assistance is just a phone call or an e-mail away. We're here, ready and waiting to help you. We understand the constraints you're under. After all, we were once in your shoes. That's right: before joining Arivis we were clients ourselves. Largely as a result of our experiences, we feel compelled to respond to your requests quickly and efficiently. Upon receiving your request, we immediately set to work finding solutions. We are committed to our clients success and respond accordingly. You will have dedicated support where and when you need it. Arivis, Inc., Confidential
39. 39. Arivis Professional Services Members of the PSG hale from various life science companies including Bristol Myers- Squibb, Eli Lilly, Celgene, Cell Therapeutics Inc., C.R. Bard, Medicis, and ImClone Systems. We were once in your shoes and feel compelled to respond to your requests quickly and efficiently. Provides premier strategic and tactical services to fit your specific regulatory needs. The Arivis PSG live and breath quality, flexibility, and responsiveness. Arivis, Inc., Confidential
40. 40. What We Do eCTD Quality process definition, implementation, and documentation Training eCTD Publishing and Compilation Planning & Management eCTD strategy Publishing guides and project rules Define, interpret, and communicate Regulatory submission requirements eTMF and eDMS Design and implementation Scanning, indexing, and archiving Templates, style guides Arivis, Inc., Confidential
41. 41. Arivis eTMF Professional Services Optional eTMF Professional Services in addition to your software include: Document Scanning / Conversion Services eTMF Reference Model Classification and Organization Services Ongoing eTMF Management Capabilities Customer Support for Clinical Process Implementation Complete eTMF Trial Management Arivis, Inc., Confidential
42. 42. Thank You Clireo eTMF Demo www.m3.arivis.com Tricia McQuarrie Tricia.McQuarrie@arivis.com Clinical Operations Manager Arivis, Inc.