Efficient management of documentation is key to the successful development of new molecules. It is also often one of the most challenging aspects of managing a clinical program. There are efficiencies to be had through the use of an electronic system compared to paper, however, these systems can be time consuming and expensive to put in place. This webinar will focus on the challenges and opportunities that small to medium enterprises face when trying to improve their document management processes within the context of clinical trials. Topics will include: • Where we have come from and where we are today • Drivers to adopt electronic document and records management • Changing regulatory expectations • What are my options – Paper, On-Premise, Cloud • Benefits of a structured approach to EDM • Document Management Challenges faced by SMEs • Montrium’s approach to delivering Document Management for the Life Sciences in the cloud • Future Trends in Records Management

1. Document Management in the
Life Sciences – New Horizons for
SMEs

2. Agenda
 Where we have come from and where we are today
 Drivers to adopt electronic document and records
management
 What are my options – Paper, On-Premise, Cloud
 Benefits of a structured approach to EDM
 Document Management Challenges faced by SMEs
 Montrium’s approach to delivering Document
Management for the Life Sciences in the cloud
 Changing regulatory expectations
 Future Trends in Records Management
 Q&A

3. If you have a question
Raise your hand and I will answer at the end of the
webinar
Or you can type a question in the Questions Pane

4. Where have we come from?
• EDMS has been around for over 20 years
• Life sciences are large producers of documents
• We have focused a lot on data and still have
many paper records
• Document Management systems were
traditionally thought of as enterprise systems
and not readily available to smaller
organizations
• New systems are emerging on the cloud

5. Many, Many different documents
TMF
(~350 Types)
Regulatory
Docs
(~150 Types)
Quality
Docs
(~30 Types)
Other
Docs (~300 Types)

6. We still have a Paper Mindset!
• We still organize electronic
documents in folders
• We still produce paper or
electronic outputs which we
systematically sign
• We produce paper-like outputs from
electronic systems and file them in
our TMF or central files
• We tend to print out content for
inspections
WHY?

7. Why
• Documents are produced by many different
stakeholders in many different locations
• EDMS type systems have been traditionally
expensive and time consuming to
implement
• File shares are relatively inexpensive but
require the use of folders to manage content
• File shares are easy to understand
• Without a validated EDMS, it is difficult to
meet the requirements of 21 CFR Part 11

8. What are my options?
• Paper
–
–
–
–
Still acceptable from a regulatory standpoint
Easy to understand and implement
Not very efficient and difficult to find information
Can be costly to maintain archives during retention
period
• Electronic File Share
–
–
–
–
–
Mimics paper based system
Limited search capabilities
Security can be challenging
No audit trail
21 CFR Part 11 compliant?

9. What are my options?
• EDMS – On Premise
–
–
–
–
–
Typically an enterprise type solution
Can be costly to implement and maintain
Easier to integrate with other applications
Requires in-house expertise to manage system
Not really warranted for smaller organizations
–
–
–
–
–
Minimal upfront investment
Pay per use model
Multi-Tennant
Minimal in-house expertise to manage system
WYSIWYG – Minimal customization allowed
unless in a dedicated environment
• EDMS – Cloud based

10. Drivers to implement an EDMS
eCTD
Information /
Knowledge
Management
Lack of
Security and
Control
Versioning
Issues
Global
Teams
EDMS
Too
Much
Email
Due
Dilligence
Archiving
Cost /
Space
Partnerships

11. High Level Requirements of an
EDMS
• To be able to:
–
–
–
–
–
–
–
–
–
–
–
Organize and classify all documents and records (content)
Assign metadata values to content
Manage collaboration on documents in one central location
Distribute document templates
Version documents and maintain document history
Manage document revisions and source documents
Manage records centrally and provide access to inspectors /
auditors (eTMF)
Apply retention policies to records
Apply security and audit trails
Allow electronic signatures of records
Provide records for submissions (eCTD)

12. Benefits of EDMS
• Better version control of documents
• Improved collaboration between study
stakeholders
• Improved timeliness of document authoring and
collection
• Reduction of document collaboration via email
• Improved security, control and traceability
• More reliable backups of documents and records

13. Benefits of EDMS
• Reduced document management and
archiving costs
• Improved ability to search for content
• Improved knowledge management
• Better regulatory compliance
• More consistent content through the use of
templates

14. How to select and implement
a solution…
• Step 1 – Requirements
– Establish a clear set of concise and measurable
requirements
– Define your current and future document management
processes in a process diagram – Try and standardize if
possible
– Decide if you want a cloud based or on-premise solution
• Step 2 – Vendor Identification
– Identify potential vendors who could be a good fit for
your organization’s size, needs and processes
– Ask vendors to review your future document
management processes and provide a gap assessment
between their standard processes and yours

15. How to select and implement a
solution…
• Step 3 – RFI/RFP
–
–
–
–
Evaluate whether an RFI/RFP is necessary
Define how you will evaluate the vendor responses
Build RFI document based on your requirements
Evaluate responses and shortlist
• Step 4 – Vendor Selection
– Select vendor based on RFI/RFP response and their
ability to meet your requirements
– Perform due diligence – on site or postal audit
– Verify references
– Contract with vendor. If cloud based, make sure that an
adequate Service Level Agreement (SLA) is in place

16. How to select and implement a
solution…
• Step 5 – Establish a standard taxonomy
– Define a standard set of document names and
metadata
– Leverage the EDM and TMF reference model as much
as possible
– Standardize across functional areas
• Step 6 – Establish configuration
– Aim to leverage existing configurations from the
vendor as much as possible to save time and cost
– If deploying in-house, the configuration should be
governed by the configuration control SOP
– If deploying on the cloud, the vendor should define the
configuration with you

17. How to select and implement a
solution…
• Step 7 – Deploy and Validate
– If deploying in-house, you should have the
necessary SOPs to validate and manage the system
– You only need to validate customizations and the
implementation of your processes (UAT)
– Try and leverage vendor documentation as much
as possible
– Cloud based solutions should be pre-validated and
only minimal UAT is required
– Roll out in a staged manner

18. How to select and implement a
solution…
• Step 8 – Train, train, train
– User adoption of an EDMS can be challenging
– Often users do not understand the concepts such as
metadata and document collaboration
– Ensure you have a comprehensive training
program in place to facilitate adoption
– Develop cheat sheets and leverage vendor user
guides and other documentation
• Step 9 – Expand and maintain
– Ensure proper system management procedures are
in place
– Expand the use of the system to other departments
or externally to partners and vendors

19. Leveraging Models and Standards
• Leverage document models. Examples of these
could be:
– DIA EDM Reference Model
– DIA TMF Reference Model
– eCTD
• The use of industry models and standards
facilitates collaboration, inspection and
interchange
• Many vendors have already implemented
these models in their solutions

20. Importance of establishing a
Taxonomy
Definition:
•tax·on·o·my (tk-sn-m)n. pl. tax·on·o·mies 1. The
classification of organisms in an ordered system
that indicates natural relationships.
•2. The science, laws, or principles of classification;
systematics.
•3. Division into ordered groups or categories

21. What can we do with a
taxonomy?
• Implement document and information
management systems
• Centralize terms and classification across
systems to facilitate integration and improve
standardization
• Automate processes through use of metadata
and classification
• Identify documents/records
• Manage records lifecycle and retention
• Search for information based on predefined
classification
• Generate Metrics and KPIs

22. How to define your taxonomy?
• Establish taxonomy governance rules
• Perform a GAP assessment of your existing
standard and the reference models to define an
initial taxonomy
• Organize the GAP assessment in a document
with current standard and proposed standard
• Leverage the reference models as much as
possible
• Define standard sets of metadata
• Organize work groups with the different
functional areas to review and refine the standard
• Update and deploy

23. Document Management
Challenges for SMEs
• Cost of Acquisition of on premise EDMS solution
is prohibitive
• Lack of in-house staff to manage an EDMS
solution
• Lack of time or knowledge to define the
configuration for an EDMS
• Inspection / audit / due diligence readiness
can be challenging without an EDMS
• Difficult to archive documents from vendors

24. Cloud based EDMS
Model
• SharePoint 2013 based multi-tenant
environment
• Full enterprise EDMS features
• Fully mapped to the EDM and TMF Reference
Models
• Pay per user / per month
• Minimal setup cost
• Can be up and running within 2-4 weeks
• Targeted towards SMEs
• Includes full configurations for eTMF and
Regulatory documents

25. How does it work
• Montrium is responsible for the setup and day
to day management of your environment
• We follow our own SOPs for things like security,
disaster recovery, validation etc.
• We provide you with training and support
• We make all changes to your configuration on
your behalf
• You manage all of your documents and
metadata

26. EDMS Components of
Montrium Connect

27. The Regulators are going
Electronic…Case Study
• The EMA published a position paper in
February which gave us more clarity on what
they are looking for
• It also laid down the conditions by which they
wish to inspect eTMFs
• They share the same or similar requirements
to the sponsors themselves
27

28. High level eTMF requirements of
the regulators
Based on the position paper entitled ‘Reflection paper on GCP
compliance in relation to trial master files (paper and/or
electronic) for management, audit and inspection of clinical
trials’, the regulators needs can be summarized as follows:
• To be able to see all study information in one place
• To be able to review this information without intervention from
sponsors or clinical site staff
• That information be collated in a timely manner (i.e. be up to
date)
• That inspectors are able to reconstruct the events of the study
and evaluate compliance with GCP
• That inspectors require a minimal amount of training to be able
to use the system
• That potentially inspections could be done at a distance

29. High level eTMF requirements of a
sponsor
•
•
•
•
•
•
•
•
To be able to understand the status of the clinical trial
and eTMF in real-time
To be able to present all eTMF records (documents and
data) from different systems in one federated eTMF
To be able to leverage the eTMF content to facilitate a risk
based approach to clinical trials
To be able to apply a risk based approach to TMF QC
To be able to view eTMF record structures in different
views based on metadata
To be able to answer key questions through structured
and unstructured queries and natural language
To ensure that the authoritative source is clearly identified
and that there is only ‘one version of the truth’
To reduce the overhead of maintaining an eTMF and
transform it into a source of valuable knowledge

30. Future trends in EDMS
• Regulators are going electronic
• Cloud will be the new norm
• Documents will drive more and more
processes
• Documents will be data
• Interchange standards will become
mainstream

31. Final Recommendations
• Clearly define your EDMS needs and process up
front before choosing a solution
• Properly vet cloud based providers to ensure your
documents are properly protected
• Try and adopt industry models and best practices
which are already built in to the solutions
• Stage your EDMS rollout so as to gradually bring
on different functional groups
• Encourage your partners and vendors to
collaborate within your environment

32. Conclusion
• As our world becomes more and
more electronic, the need for a fully
functional EDMS becomes more
important
• There are real cloud based options
which now allow SMEs to access
enterprise EDMS quickly and cost
effectively
• Its time to go paperless!

33. Q&A
If you have a question, please raise your hand
Or you can type a question in the Questions Pane

34. Contact Details
Montrium Inc.
507 Place d’Armes, Suite 1050
Montreal (QC) H2Y 2W8
Canada
+1.514-223-9153
Montrium S.A.
9, Avenue des Hauts-Fourneaux,
L-4362 Esch sur Alzette
Luxembourg
+352.20.88.01.30
pfenton@montrium.com
www.montrium.com