eClinical TRIALS
Dan Wheeler
Rethinking
Document
Sharing
The benefits of peer-to-peer
networking over email, fax,
FTP, and hosted solutions.
PHOTOGRAPHY OLGA CHERNVAK/GETTY IMAGES. ILLUSTRATION DAN WARD
T
he need for sponsors to collaborate
with external partners, whether it's
legal counsel, CROs, or manufacturers
has become a daily occurrence.
Documents such as contracts, informed
consent, and protocols require authoring,
review, and approval from individuals inside and
outside the company. This trend will continue,
as industry increases outsourcing efforts at the
same time the amount of unstructured content
generated skyrockets.'
There are many different use cases in the
clinical trial process that require this type of data
exchange. For example. Investigator's Brochures
are exchanged between sponsors, investigators,
and Institutional Review Boards (IRBs). These
are not static documents, thus requiring
collaboration as updates are needed. Creating,
reviewing, and approving informed consent
language requires a collaborative process that
involves input from investigators and IRBs.
Failure to have a reliable, consistent, and
compliant approach to document exchange and
collaboration with relevant parties can result in
unnecessary delays and additional costs.
Current challenges
Many CROs and sponsors collaborate and
exchange content either through email, fax, File
Transfer Protocol (FTP) or hosted third-party
16 .APPLIED CLINICAL TRIALS SUPPLEMENT appljedclintcaltríalsonline.coni
solutions. Each method has disadvantages in
terms of security, document versioning, cost,
efficiencies, and information loss.
For example, email may be easy to use, and
is by far the most widely used communication
mechanism, however, sending attachments this
way is typically not secure because most of us
aren't encrypting attachments. Attachments also
cause our mailboxes to quickly exceed their
quota. More troublesome is that there is often
confusion about which version of the attachment
is the latest. The end result is a time-consuming,
frustrating, and error-prone process of manually
merging multiple documents to ensure the latest
edits are incorporated into a single document.
Like email, facsimile technologies are
commonplace in the workplace. Most fax
solutions today convert incoming faxes to digital
format and email the document to the recipient.
This may be sufficient if the receiver does not
need to modify the document. However, in a
collaborative environment where both the sender
and receiver must author or edit the document,
the resulting PDF or TIFF is not an editable
document and is unsuitable for this purpose.
FTP collaboration, while not as commonly used
as email or fax. has a long history of providing
a secure means of exchanging files. However,
these solutions require more advanced technical
knowledge, are cumbersome, and typically
March 2010

require IT involvement to set up and configure permissions.
Security aside, the lack of version management is as much a
problem with FTP as it is with email.
Some hosted third-party ("on-demand") solutions solve
some of the problems of email and fax by providing a
common repository for all parties so there should be no
question about which version of the document is the latest.
Features such as document version control are useful in
that you can go back to an old version of a document and
have greater insight into how it changed throughout the
collaborative process. However, not all on-demand solutions
offer versioning features, including one of the leading
solutions. Some on-demand solutions do provide audit
capabilities. This provides for better compliancy by tracking
the user, date, and time for each document change.
On-demand solutions have a potentially large cost
downside, however. These services typically charge by
the number of documents or the amount of storage space
consumed. As such, they can quickly become expensive. In
addition, these solutions require a username and password
to connect, which is typically not synchronized with the
user's network username and password. This requires
users to remember yet another username and password.
The drawbacks associated with all of these methods, some
quite serious, has escalated the need to find a more secure,
cost-effective, and user-friendly way to manage documents.
Peer-to-peer data sharing
Another solution is peer-to-peer data sharing, which is an
approach to computer networking where all computers
share equivalent responsibility for processing data. Peer-to-
peer networking (also known simply as peer networking)
differs from client-server networking, where certain devices
have responsibility for "serving" the data and other devices
consume or otherwise act as "clients" of those servers.
In a peer networking solution, desktop computers can
be configured to allow sharing of files, printers, and other
resources across all connected devices, allowing data to
be shared easily in both directions—whether downloads to
or uploads from your computer. Peer networking can also
handle a very high volume of file sharing traffic because
the load is distributed across many computers.^
Because trial-related documents contain proprietary
information and sensitive data, improved security is a
must. For example, if a CRO is working with three separate
sponsors, it is important, from both a compliance and
contractual standpoint, to have three separate workspaces
to reduce the risk that a confidential document from
sponsor A is not seen by sponsor B. Peer networking
documents that are exchanged between any two parties are
stored within their own individual workspace.
An effective peer network also automatically encrypts
and replicates data among users, allowing every user to
March 2010 appiiedclinicaltrialsonline.com
eClinical TRIALS
have constant access to the latest shared documents—even
if they are not online. It is also important for the solution
to encompass built-in disaster recovery by having the data
stored In at least two separate locations.
Peer networking should allow CROs to track and manage
documents in several ways, including version control and
status change notifications via email or text. Additionally,
automatic status update indicators should be displayed to
alert users of new updates within the application.
Infrastructure and integration
One of the most important benefits of a peer networking
solution is the elimination of the storage and file-transfer
costs typically associated with on-demand services. The
ideal peer networking solution requires minimal end-user
training and greatly reduces administration, resources,
and maintenance from a central IT infrastructure, lowering
overall costs and accelerating the investment payback.
An exchange and collaboration solution should allow for
integration with an existing document management system.
For example, take the scenario where an Investigator's
Brochure is initially created. The authoring and review
should happen in a collaborative workspace but, once
complete, it should be moved seamlessly into a document
management system such as Documentum or SharePoint,
where it can go through a formal approval process
with electronic signatures. When the brochure needs
to be modified at a later date, a change request should
be submitted, and once approved, the brochure should
seamlessly be copied back into the collaborative workspace.
Then it can be modified by all relevant parties. After the
brochure is revised, it should be moved or published back
into the document management system.
Conclusion
A good peer networking solution will allow sponsors and
CROs to balance multiple factors such as cost of ownership,
ease of use, robust version control capabilities, auditing,
and integration into a true document management system.
The end result: a secure and comprehensive solution with
improved workfiow, 21 CFR Part 11 compliant eSignatures,
change management, and records retention capabilities.
References
1. J. Malek. Transforming Life Sciences: The Connected Life
Sciences Company, Cisco Internet Business Solutions Group
(IBSG), July 2009.
2. A. Oram, Peer-to-Peer, Harnessing the Power of Disruptive Tech-
nologies (O'Reilly Media, Sebastopol, CA, 2001).
Dan Wheeler is President and Cofounder ofSitrof
Technologies. 700 Alexander Park, Princeton, NJ 08540,
email: dwheeler@sitrof.com.
APPLIED CLINICAL TRIALS SUPPLEMENT 17
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