Clireo eTMF Solution by arivis

eTMF
Tricia McQuarrie
Clinical Operations Manager

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

US Headquarters
Phoenix AZ
Global Headquarters
Munich Germany
Development Center
Rostok Germany
Global Organization

Who Uses Arivis?

What you do is incredibly important. It is also very
challenging.

That is why you need ONE, easy-to-use cloud-based
system for one and all of your users needs.

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.

And we have been doing this a while. Our 21 CFR Part 11
cloud technology has been serving clients since 2007.

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

eTMF and
Arivis Professional
Services

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)

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
sponsor’s 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.

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

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.

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

Benefits of an eTMF

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%

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/institution’s site and at the sponsor’s
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.

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

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

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

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.

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.

The integrated HTML
5 viewer securely
lets users view
document content
on any platform or
browser
View Documents
Anywhere…on Any Device

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 Partner’s Systems

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

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

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

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

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

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

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 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.

 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.

 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

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.

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.

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.

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.

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 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

Thank You
Clireo eTMF Demo
www.m3.arivis.com
Tricia McQuarrie
Tricia.McQuarrie@arivis.com
Clinical Operations Manager
Arivis, Inc.

Clireo eTMF Solution by arivis

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