Accelerating Translational
Research and Clinical
Studies Using Virtual
Data Rooms
BY MICHELLE SMITH
In the life science research arena,
competitors struggle daily to accelerate the
product development life cycle associated
with bringing quality healthcare solutions
and discoveries to market. This white
paper makes the case for a virtual data
room, a centralized document
management solution that is
affordable, secure and provides
controlled easy accessibility for sponsors,
investigators, stakeholders and regulatory
authorities.
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TABLE OF CONTENTS
The Case for Virtual Data Rooms............................................................................ 3
The Critical Path Towards ....................................................................................... 4
Efficient Document Management ............................................................................ 4
Surveying the Critical Path – Obstacles and Roadblocks ................................................... 4
Surveying the Critical Path - Needs ................................................................................... 5
Surveying the Critical Path - Industry Challenges .............................................................. 7
The Critical Path Forward – Technological Strategies...................................................... 10
The Critical Path Forward – Results and Benefits ............................................................ 11
The Critical Path Forward – The Validation Process ........................................................ 14
Conclusion .............................................................................................................. 17
About the Author .................................................................................................... 17
Resources ............................................................................................................... 18
Appendix ................................................................................................................. 19
Affordable Secure Information Exchange ......................................................................... 19
The V-Rooms CFR 21 part 11 Validation Process ........................................................... 20
Program Features................................................................................................... 21
Document encryption ....................................................................................................... 21
Password Control ............................................................................................................ 21
Watermarking .................................................................................................................. 21
Intuitive Design ................................................................................................................ 21
Advanced Search Functionality ....................................................................................... 21
Activity Tracking .............................................................................................................. 22
Reporting ......................................................................................................................... 22
Terms Of Use .................................................................................................................. 22
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The Case for Virtual Data Rooms
Affordable and effective document and data management solutions
are currently seldom used for studies by life science researchers and
professionals. Negotiating the critical path forward by moving from a paperdriven clinical trial to an electronically efficient trial in order to accelerate the
process and achieve high quality results involves more than just a review of
unsuccessful systems currently in place. What is required of these studies is
more than just an investment in a document management solution. It’s
pivotal that the investment includes a service team that understands the work
of the clinical trial team and how roles shift and reintegrate after
implementation of a document management solution.
This white paper makes the case for a centralized, easily accessible
document management solution using Virtual Data Rooms (VDRs) to
promote time management and efficiency in initiating a study for sites,
sponsors and Contract Research Organizations (CROs). Topics include:




The current state of document management at study sites
The challenges facing site management in acquiring a document
management solution
The benefits and rewards for both study facilities and sponsors
The importance of validation as a process required by the FDA
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The Critical Path Towards
Efficient Document Management
SURVEYING THE CRITICAL PATH – OBSTACLES AND ROADBLOCKS
To get medical advances to patients, product developers must
successfully progress along a multi-dimensional critical path that leads from
discovery or design concept to commercial marketing. There is a
technological disconnect between the discovery and the product
development process – the steps involved in turning new laboratory
discoveries into treatments or products that are safe and effective. The
current medical product development process is no longer able to keep pace
with basic science innovation. Today’s translational research and clinical trial
facilities are swimming in information and drowning in documents. Critical
process changes are needed to improve the product development process
itself by establishing and using new technological tools for document and
data sharing, organization and management. The use of virtual data rooms
provides such a solution, allowing document exchange and review from the
very beginning of the study process.
The rise in the number of investigative sites has
increased the need, complexity and cost of exchanging
and managing documents and data related to clinical
trials. In this ever-increasingly regulated environment, the
continued use of traditional, non-secure methods – email,
fax, overnight courier – to exchange confidential and time
sensitive documents could eventually prove devastating
when this manual system fails to securely manage and
transfer critical study data within, to and from the various
study stakeholders.
“There are mountains of
documents generated
during preclinical and
clinical phases. Without
an efficient system for
managing those
documents, thousands
of man-hours are
spent even on the
simplest of tasks.”
There are mountains of documents generated during the
preclinical and clinical phases. Without an efficient
system for managing those documents, thousands of
man-hours are spent even on the simplest of tasks. Not
only does the number of documents grow during this phase, but the number
of people who review and revise those documents grows exponentially as
well. There are costs involved in providing a solution. According to Gartner,
a world renowned IT research firm, companies can spend more than 75% of
their IT budget on maintaining their traditional software systems. A virtual
data room solution would provide not only a means of secure document
exchange, but it would also speed the study’s life cycle process by allowing
real-time document review and updates, while providing automatic
notification to key personnel when new documents or data are available for
review.
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SURVEYING THE CRITICAL PATH - NEEDS
There is a growing critical need for a more flexible, scalable, secure
and central repository of documents - a need for a technological tool to allow
facility staff members and key sponsor personnel to access all of a trial’s
documents residing in a real-time accessible location. Different levels of user
access need to be provided to determine what information is available to
each user, complete with automated audit trails detailing document usage.
There is also a need for document exchange,
management, secure storage and retrieval processes.
A
cohesive document management solution to provide a secure,
compliant and easy-to-use portal for preclinical and clinical
documents is imperative to the long term success of any study.
What is needed is a solution that stores active trial documents
from various sources which is compliant with FDA requirements,
as outlined in the Code of Federal Regulations (CFR) 21 Part 11
that would support data controls and provide audit trails for
traceability.
Envision a document management solution that would
enable study directors, sponsors and facility team members to
manage, organize, search and review the massive amount of
information generated during the study. Imagine a solution that
could then be used to help assimilate the final study findings and
reports that are generated and returned
to a study sponsor. Such a document
management solution would shorten the amount of time needed for the
clinical trial process, which translates into thousands and in some cases,
millions of dollars in cost savings.
There is a also an increasing demand for global site communication,
accelerated secure document exchange and simplified tracking, that would
enable study teams to attain key milestones more quickly and efficiently than
the current paper-based process allows.
These teams need a central
repository for all documents that would enable study communications with all
participants to be as efficient and secure as possible.
Start-up
documentation should be available and distributed in a real-time manner with
completed documents collected and stored in one central organized, secure
location. For the sponsor and CRO, the ability to ascertain the accuracy of
information through the provided solution is critical to improving cost control
and meeting timeline milestones. A virtual data room solution will allow
updates to study documents, help with establishing standard operating
procedures and allow real-time monitoring of contract revisions and
approvals.
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Teams need the ability to review and confirm documents
electronically instead of relying on unsecured email exchange of information
or waiting until the next on-site visits. With clinical trials underway on a
global basis, site operators, management personnel and sponsors alike need
to be able to access documents from a web browser 24x7x365 from
anywhere in the world. These same people need the ability to share files of
any size and type, with any party without using email as a delivery
mechanism.
To make this cost effective and manageable, team members need a
way to store and organize the documents they already have without
migrating them to some standard format before uploading to share with
sponsors and other study personnel. There is a need for informatics support
on a core facility level. Such service cores would use a common information
and document exchange portal to meet exchange demands of all modern file
types and formats.
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SURVEYING THE CRITICAL PATH - INDUSTRY CHALLENGES
The lack of document exchange solutions and cohesive data
management systems for facilities in the translational research and
pharmaceutical industries is of critical concern. Such sites are in dire need to
store, mine, search and assimilate the massive amounts of information and
documents generated during the study process. From the very start of a
product development life cycle, the ability for a sponsor or CRO to track the
status of key documents is vital to the study process. Documents generated
during contract and budget negotiations and during
the review and approval period by Institutional
“From the very start of a product
Review Boards (IRB) are critical to the start-up of the
development life cycle, the ability
study. A research site’s inability to manage and
for a sponsor or CRO to track the
track these documents successfully continues to be
status of key documents is vital to
one of the main causes of delay in time-to-market for
the study process.”
products and drug development.
Long-term
document and data storage for study information is
also a concern since information related to a study must be maintained and
accessible for up to seven years.
Most facilities continue to use multiple ineffective methods of
document storage and exchange. The data and documents may be stored
on individual computer workstations, numerous server machines and various
independently managed portable storage devices. The downfalls in these
types of systems are:










“Lost” information due to the inability to search multiple individual
workstations for documents
The inability to recover lost documents and information in the event of
workstation crashes or failures
An inability to track document revisions or notify key personnel when
new information is received on an existing study
Time consuming and costly maintenance and upgrades for software
on workstations and servers
Difficulty in guaranteeing that individual stations are backed up
properly in the event of workstation failures
Lack of provision for audit trails created for receiving, editing or
sending documents
Confidential information stored on unsecured workstations which may
be accessed by unauthorized personnel
No system to create a centralized calendar for facility personnel to
stay aware of study milestone dates and the status of those events
Compliance issues with workstations and the software used to create
and store documents
Expensive and unpredictable costs for hardware, software and IT
personnel to manage the systems
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Also important is the concern for a secure environment for preparing
confidential time-sensitive documents during the study process. The site
coordinators and sponsors need access to important information regarding
stored documents: which documents were viewed, who viewed them and
when they were viewed. In addition to providing secure information storage,
the ability to distribute information in a quick and secure manner while at the
same time eliminating difficult-to-manage File Transfer Protocol (FTP) sites
and internal servers, would help to avoid security concerns and capacity
limitations of using email.
Long term archiving of scientific data is also a major concern. There are
prominent issues with increases in the number of files and their
corresponding sizes in addition to the proliferation of complex and varied file
formats. Also, many facilities utilize their own methods for organizing data
and face problems including truncated filenames and the absence of
nomenclature for data sharing.
According to a survey of 252 US-based investigative sites, approximately
twenty-five percent of survey respondents working with paper-based
methods of communication claim
to spend in excess of three
hours per week searching for
documents.
Fifty-two percent
stated that when traditional
means, such as faxing, mailing,
or overnight courier, are used
sponsors ask them to re-send
documents a couple of times a
week.
Without the ability to
effectively track the delivery for
critical
documents,
such
redundant efforts tend to be
commonplace. Internal software
solutions to address these
issues are often too expensive or
complicated. The absence of a
means for organizing and
searching for documents based
on key words or subject matter in
the assimilation of study data
inhibits study directors in the
preparation of final reports for
sponsors.
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Many facilities attempt to develop custom data and document
management solutions and although a few succeed, many find the process
time consuming and expensive. With the widespread use and accessibility
of the Internet, translational research and pharmaceutical facilities have new
options when seeking a solution for document exchange and data
collaboration. The use of virtual data rooms provides such a solution,
allowing document exchange and review throughout the study process.
Assumptions
A knowledge worker’s annual salary is $80,000 (a low estimate). The
average knowledge worker spends six hours per week or a conservative 15%
of work time on average searching. These searches are unsuccessful an
average of 50% of the time resulting in an overall 7.5% wasted time,
depending on the type of search.
Calculation of Cost
$80,000 x 7.5% = $6,000/year in time spent in wasted searches per
knowledge worker.
$80,000
per year
annual
salary
7.5% wasted
search time
1,000 workers
in enterprise
$6,000,000 per
year loss
The Cost of Wasted Time
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THE CRITICAL PATH FORWARD – TECHNOLOGICAL STRATEGIES
By establishing document management and collaboration strategies
at the start-up of a study, a team could accelerate the clinical life cycle and
add layers of security and control over the entire process. The team needs
the timely ability to track, manage and review the latest documents, from IRB
approvals to site and study contracts. To accelerate the process, studies
need a single, centralized, web-accessible, secure location where scientists,
facility operators, management personnel and sponsors alike may easily
monitor and share the information from the launch. The ability to coordinate
activities without having to rely on emailed, faxed or shipped documents is
necessary. This approach significantly reduces the need to schedule
physical “sit down” meetings to review these documents.
As the study begins, the ability to have access to a portal, by logging
in and viewing documents from site researchers, combined with an event
calendar for the study, is highly desirable. Also, being automatically notified
of any documents that need review or approval would eliminate the hours
wasted searching for documents in their physical location. An automated
process to ensure that team members who need to know that new
information is ready and available, just by the document itself being uploaded
to a virtual data room, saves time and money.
As the study progresses and the time nears to begin assimilating the
massive number of documents generated during a study, the program
director needs the ability to log in to a central repository to turn the concept of
a solution into a concise presentable package. This
summarized package then can be presented to a
“This approach significantly
sponsor during the study and at its completion. The
reduces the need to schedule
hurdle is doing so in a consistent and timely manner.
The current path of gathering notebooks of
physical ‘sit down’ meetings to
handwritten pages, spreadsheets full of data from
review these documents.”
individuals, data from other scientific devices and
documents or images supporting the findings acquired
during the study progress is quite daunting. This wide collection of
information needed to formulate the final study report is, in some cases,
overwhelming for a study director. The burden of assimilating mountains of
unruly documents can end up causing delays in producing the final study
report that is crucial to medical product development.
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Software solutions can be supplied as both “validated” and
“validatable”. Software is validated in the sense that it has been verified by
the vendor and functions according to project specifications. Software that is
validatable extends the responsibility to the in-house software administrator
to ensure compliance with current document storage and retrieval
regulations. Re-validation in both instances is necessary to accommodate
changes due to software upgrades and system maintenance.
By hosting data in a virtual data room, not only are operational
efficiencies increased, but there is also the ability to:





Pool data across phases
Allow staff to oversee and manage study trial data through a single
role-based user interface
Obtain rapid, near real-time access to data
Respond to regulatory authority questions quickly and confidently
Utilize data to make go/no-go decisions
The data should be stored in a centralized environment to which access
is provided based upon defined roles and security policies. This eliminates
the time that is spent tracking down information internally or through a CRO,
allowing more time to focus on analyzing data more productively and
proactively.
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THE CRITICAL PATH FORWARD – RESULTS AND BENEFITS
Document management is the first critical step in developing a cohesive
data management solution for pharmaceutical research sites. Can the
pharmaceutical industry leverage knowledge management to reconfigure the
pharmaceutical value chain and harness the benefits of document
management solutions more efficiently? Companies need to start thinking in
terms of “Return On Investment” (ROI) as well as “return on experience.” An
investment made in software solutions and validation processes could
transform a struggling operation into a successful, market-ready leader in the
pharmaceutical research arena.
Access to information on health and medicine via the Internet has altered
society’s expectations with the healthcare industry. Electronic data systems
integrated with preclinical and clinical trial management systems will require
more sophisticated functionality.
This endeavor requires three main
elements:



A shared, secure document exchange system
Trained and willing collaborators and staff
A common online environment in which to work
(i.e. the Cloud)
A successful web-based document management
solution would assure effective document control
throughout the entire product development life cycle by
simplifying
workflows,
promoting
efficiency
and,
centralizing document exchange and storage while making
compliance easier. The creation of an environment for
early document review would speed up the submission and
assembly processes, thereby reducing time to market.
Time and cost associated with travel and the sheer volume
of paperwork involved would be drastically reduced.
“Access to
information on
health and
medicine via the
Internet has
altered society’s
expectations with
the healthcare
industry”
This would enable the researchers and sponsors to
archive, mine and collaborate on preclinical or clinical study documents.
Additionally, web-based systems require no installation, storage or
maintenance on in-house computers.
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Providing a Software-as-a-Solution (SaaS) infrastructure for document
management will allow companies to focus on their core business efforts,
accomplishments and results. On-demand document exchange systems
additionally allow sponsors to review materials and provide approval
electronically, resulting in increased efficiency through automation. A virtual
data room reduces the overall document cycle time and simplifies document
management through its automated notification functionality. The tracking
features help identify bottlenecks in document flow – receipt, review,
approval and return – by showing when a document was received and from
whom, and by showing who has reviewed and revised each document, a
feature critical for compliance purposes. A virtual data room should be able
to handle all types of documents and files such as web pages, XML files,
audio, video, images and PDF documents, just to name a few.
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The unique and complex content-related technology needs of the
pharmaceutical industry push most software limits. The document
management requirements are intensive, and missed information can cost a
company years of research and millions of dollars. According to Michael
Padilla, COO, TCA Group Bio-Life Science Division, the total time-to-market
for a new drug now averages 10-15 years, and the average cost for bringing
a new drug to the clinical trial stage is a staggering $802 million. Within the
seven major challenges that Padilla identifies in his article, four of these are
addressable with a virtual data room solution:




Reducing time-to-market in order to achieve double-digit growth in
earnings and revenue
Reducing both drug development costs and drug expenses for
consumers and insurance companies
Increasing patent protection and reducing litigation
Growing tendency for drug companies to merge or partner to fill the
pipeline and reduce costs adds to the complexity of building
integrated information systems
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THE CRITICAL PATH FORWARD –
THE VALIDATION PROCESS
The FDA’s CFR 21 Part 11, has encouraged the drug industry to migrate
towards electronically stored information. These guidelines allow
pharmaceutical companies to use electronic documents "in lieu of paper
records, both when submitting documents to the FDA and when maintaining
internal drug company documents.”
Drug companies have been
electronically storing much of their supporting data for new drugs since the
1990s, and acceptance of documents submitted in electronic format was a
critical FDA decision. Companies that provide industry-specific software
applications with both specialized and standard productivity tools to manage
the information are emerging on the clinical trial scene.
While instituting a document solution to enable pharmaceutical research
organizations to produce study results in a timely and efficient manner is
critical, regulatory requirements place the burden of system and software
validation on the sites, or end-user,
performing the Good Laboratory
Practices (GLP) studies.
The
validation
process
consists
of
identifying and testing all aspects of a
process that could affect the final
report or product. Prior to the testing
of a process, the software itself must
be properly qualified.
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The General Principles of Software Validation (FDA 2002) states that
"software verification provides objective evidence that the design outputs of a
particular phase of the development life cycle meet all of the specified
requirements for that phase." It also defines validation as: "Confirmation by
examination and provision of objective evidence that software specifications
conform to user needs and intended uses, and that the particular
requirements implemented through software can be consistently fulfilled."
The software validation guideline states: “The software development process
should be sufficiently well planned, controlled and documented to detect and
correct unexpected results from software changes."
The above definition of validation discusses production of evidence
that a system will meet its specification. This definition does not refer to a
computer application or a computer system but to a process. The main
implications here are that validation should cover all aspects of the process
including the application, any hardware that the application uses, interfaces
to other systems, the users, training and documentation as well as the
management of the system and the validation itself after the system is placed
into use.
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Conclusion
The technological disconnect between the discovery and product
development process is a costly one. The hours lost in searching through
the massive number of documents generated in the study process have a
significant impact on the overall study cost. A successful electronic webbased document management solution will assure effective document control
throughout the pharmaceutical product development life cycle by simplifying
workflows, promoting efficiency, centralizing document exchange and
storage, resulting in maximum compliance efficiency. The creation of an
environment where documents can be reviewed quickly will speed up the
submission assembly process, thereby improving time to market.
Document management is the first critical step in developing a
cohesive data management solution for pharmaceutical research sites.
However, a software solution for document management is only one facet of
this initial stage. Also critical to the overall success is engaging a team that
understands the study process as well as the regulatory requirements
involved in storing, managing and retrieving those documents for use in the
final study reporting phase.
About the Author
Michelle Smith is an Independent Software Validation Consultant.
She assists preclinical and clinical facilities with the software validation
process including documentation and testing for installation, operation,
security, functionality and performance of software systems in a preclinical
environment, and the development of procedures to ensure that the software
system meets all quality goals that are outlined by internal quality
management processes and external regulatory bodies. Additionally, Ms.
Smith works with her clients to determine if regression testing is required with
any software updates to ensure that no new errors have been introduced
during the software enhancement update.
Her process ensures the
structural integrity of software installation and provides detailed functional
testing. Michelle has worked directly with the V-Rooms™ solution to assure
compliance with FDA CFR 21 Part 11 guidelines.
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Resources
Della Cioppa, Giovanni, John Orloff, and Isabelle de Zegher. "Delivering on the EClinical Vision."
Touch Health Sciences. Novartis Pharma AG, 2006. Web. 07 May 2011.
<http://www.touchhealthsciences.com/articles/delivering-eclinical-vision>.
"How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to
Market." NG Pharmaceutical US. GDS Publishing, Oct. 2007. Web.
<http://www.ngpharma.com/article/How-Effective-Document-Management-HelpsPharmaceutical-Companies-Accelerate-Time-to-Market/>.
"PointCross Releases Pre-Clinical Study Lifecycle and Data Management Suite (PC-LDM(TM)) For
Multi-Party Environments." PRNewswire / PointCross, 04 Oct. 2007. Web. 05 May 2011.
<http://www.prnewswire.com/news-releases/pointcross-releases-pre-clinical-study-lifecycleand-data-management-suite-pc-ldmtm-for-multi-party-environments-58464607.html>.
Padilla, Michael - COO. "Solving Information Problems in the Pharmaceutical Industry a Goal to All."
TCA Group Bio-Life Science Division, 29 May 2008. Web.
<http://www.tcagroup.com/images/Solving_Information.pdf>.
Shurell, Alison. “The Growing Complexity of Clinical Trials Requires a Software-as-a-Service-based
Approach to Document Exchange”. IntraLinks. Touch HEALTHSCIENCES.com.
<http://www.touchhealthsciences.com/articles/growing-complexity-clinical-trials-requiressoftware-service-based-approach-document-exchan>.
Szymanski, Jacek. AN INTEGRATED INFORMATICS INFRASTRUCTURE FOR PRE-CLINICAL.
Diss. CASE WESTERN RESERVE UNIVERSITY, 2007. Cleveland, OH: Department of
Electrical Engineering and Computer Science, 2008.
<http://etd.ohiolink.edu/view.cgi?acc_num=case1196266590>.
US Food and Drug Administration, Challenges and Opportunities Report – March 2004, “Innovation
or Stagnation: Challenge and opportunity on the critical path to new medical products.”
<http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/Critical
PathOpportunitiesReports/ucm077262.htm>
Zorayr Khalapyan, Alexander Roth, Lee Borenstein. “Automated Data Import and Validation
Framework for a High-Throughput Laboratory”. UCLA School of Public Health, Global Bio
Lab.
<http://www.ph.ucla.edu/gbl/publications/KhalapyanZorayr%20LabAutomation%20
LabAutomation%20Poster%20Jan2011.pdf>
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Appendix
V-ROOMS: AFFORDABLE SECURE INFORMATION EXCHANGE
The complex process of bringing a bio/pharmaceutical product, medical device or diagnostic
tool from discovery to market is expensive, risky and time consuming. Simultaneously, the
competitive landscape is getting more complex, and the FDA regulatory environment is becoming
more demanding and rigorous. This is why life science professionals use V-Rooms Virtual Data
Rooms to streamline the secure exchange of confidential information to give them an advantage in
this face-paced industry.
Whether you are an institutional technology transfer officer or a life science professional
working within an organization, you can use V-Rooms to securely share thousands of confidential
documents with an unlimited number of users. After the documents are uploaded into a secure,
centralized document repository, invite researchers, partners and other team members, who may be
located around the globe, to log in and have access to information in accordance with the permission
levels that you have established for them.
The V-Rooms Solution offers an easy-to-use intuitive interface. The document uploading
process is very simple. Your administrator has the option to simply upload documents one by one, or
prepare the entire document structure and load them all at once. You can easily search any
document including scanned documents by keywords across multiple languages.
Our V-Rooms Solution offer superior service across the entire life of a project. We assign a
dedicated project manager who will provide full support to your project. This support may include
tasks, such as scanning hardcopies, loading e-documents, indexing content and launching the
repository. You will also receive ongoing administrator assistance as well as repository hosting and
management.
The V-Rooms team takes pride in offering solutions with the focus on quality services for
each customer across the globe. Today the business world demands quick well-formed decisions
from executives. By using our solution, your team can make these decisions based on constant and
safe access to all necessary information.
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V-ROOMS CFR 21 PART 11 VALIDATION PROCESS
Our comprehensive validation process provides you with the test scripts, summary reports
and documentation required to comply with submission regulations and to meet audit demands.
V-Rooms’ validation process includes documentation and testing in your environment for
installation, operation, security, functionality and performance. A strategic validation plan will be
developed to ensure that the software system meets all quality goals outlined by your internal quality
management processes and external regulatory bodies. The plan will ensure that our software
performs as expected and produces the desired results.
Our team will provide client specific validation test scripting to ensure that all parts of the
software solution and installation have been tested. These completed test scripts will provide
documentation on the software installation and will ensure that your deployment of our software
meets CFR 21 Part 11 guidelines.
Installation qualification testing will demonstrate that the V-Rooms installation in the clinical
or preclinical environment has been done per specifications and that program storage has been
documented. Operational qualification testing will demonstrate the system operates according to
pre-defined specifications and that data integrity is maintained. Security will be verified to prevent
unauthorized entry into the system. Upon completion of the validation process, clients will obtain
industry-approved documentation for software system performance and user training verification for
site personnel.
All core V-Rooms functionality will be verified to perform as intended. Our validation solution
provides a very straightforward framework for successfully complying with the software validation
requirements of CFR 21 Part 11 as they apply to V-Rooms installations.
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V-ROOMS PROGRAM FEATURES
Consider V-Rooms Virtual Data Rooms as your online filing cabinet with a series of drawers
to store documents, presentations, medical images and audio/video files. Varying levels of access
and security may be granted to users as the study progresses. Administrators have the ability to
assign up to nine security levels and an unlimited number of security sections for further access
control delineation, as well as change a user’s access level within minutes.
DOCUMENT ENCRYPTION
Documents are encrypted during transmission using a strong 256-bit encryption on the
server which prevents unauthorized access, as information is exchanged with appropriate parties.
V-Rooms servers use Secure Socket Layer (SSL) encryption, an internet security standard used by
93% of Fortune 500 Companies and the top 10 U.S. banks and businesses.
PASSWORD CONTROL
The data in your V-Room is secured through multiple layers of protection. One of these
security layers involves user password protection. Only the client administrator is authorized to issue
usernames and passwords for access to information. Stringent password criteria may be set by the
administrator.
WATERMARKING
One of V-Rooms’ key features involves the dynamic watermarking of PDF documents
accessed by users. Each page of an accessed document contains an emblazoned watermark that
includes the authorized viewer’s name, username, download date and time, and computer IP
address. This feature creates peace-of-mind for clients and discourages unauthorized redistribution
of confidential documents.
INTUITIVE DESIGN
By listening to collective feedback from our clients, we have achieved a speedy process that
is intuitive, streamlined and easy to navigate. We are committed to being the fastest and most userfriendly service in an effort to allow our users to focus on their projects instead of technology. This
means tasks are completed within a few clicks whether you are downloading documents, searching
for specific references or inviting colleagues to participate.
The same is true of our administrative features, allowing for quick and convenient software
usage. Whether you are responsible for setting up document permissions, access levels for end
users, tracking user activity or managing ongoing content uploads, our intuitive design enables the
administrator to work easier and faster.
ADVANCED SEARCH FUNCTIONALITY
V-Rooms Virtual Data Rooms offer advanced search capabilities in large data repositories
that enable you to search through any type of content including scanned copies of documents. In
addition, full-text search capability is offered for multilingual text with optional filters. However, for
security reasons, a user is only permitted to search across content for which he or she is authorized.
We index text inside graphical content using optical character recognition technology, which
makes it possible to search for specific keywords in scanned images whether they are handwritten,
typewritten or printed texts.
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ACTIVITY TRACKING
V-Rooms’ activity tracking logs every action performed by every user within the system,
enabling administrators to monitor actions using a comprehensive audit tool. Audit records provide
crucial information in the event of a legal or regulatory inquiry. Information provided by audit reports
include data about each action, the user that performed the action, the exact date and time the user
performed the action, as well as all the additional metadata relevant to the action.
REPORTING
Our audit reports offer the most comprehensive user reporting in the industry and include file
and folder rankings to show you the most popular documents. You can easily access logs for every
document in the system, which will let you know what files have been viewed, and how often. We
also offer organization-level reports, which indicate what actions were taken by particular users
allowing you to determine various user roles.
FOR MORE
INFORMATION
Call
888-316-2047
Email
info@v-rooms.com
TERMS OF USE
Although Due Diligence Online, LLC (dba V-Rooms Virtual Data Rooms) has made every effort to
provide accurate information in this document, Due Diligence Online, LLC makes no representations
as to, and does not warrant, the accuracy and/or completeness of the information herein or its
suitability for any particular purpose. The reader assumes all risk and responsibility for his or her
reliance on, or use of, any of the material contained in this document.
ALL INFORMATION IS PRESENTED “AS-IS,” AND DUE DILIGENCE ONLINE, LLC DISCLAIMS ALL
EXPRESS OR IMPLIED WARRANTIES AND CONDITIONS WITH REGARD TO THE INFORMATION,
INCLUDING THE IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY, FITNESS FOR
A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT. IN NO EVENT SHALL DUE
DILIGENCE ONLINE, LLC BE LIABLE FOR ANY DAMAGES WHATSOEVER, INCLUDING BUT NOT
LIMITED TO DIRECT, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES,
INCLUDING WITHOUT LIMITATION LOST REVENUES OR LOST PROFITS, THAT MAY RESULT
FROM THE USE OF THIS DOCUMENT.
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