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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. US Headquarters Phoenix AZ Global Headquarters Munich
Germany Development Center Rostok Germany Global Organization
Arivis, Inc., Confidential
4. Who Uses Arivis? Arivis, Inc., Confidential
5. What you do is incredibly important. It is also very
challenging. Arivis, Inc., Confidential
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. 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. 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. 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. eTMF and Arivis Professional Services
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. 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. 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. 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. 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. Benefits of an eTMF Arivis, Inc., Confidential
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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Thank You Clireo eTMF Demo www.m3.arivis.com Tricia
McQuarrie [email protected] Clinical Operations Manager
Arivis, Inc.