"Aptly named DocExchange, the solution enables users to securely share large amounts of information across firewalls."  We are thrilled that they get it!!  They continue with...

Complete Privacy and Security

"Sitrof has taken this technology and laced in its own regulated data protection and interface with Microsoft SharePoint for the DocExchange tool."
-- Chelsi Nakano, CMS Wire

Content Circles has really blossomed since we first noted their server-free collaboration tool in January of last year. Designed to help distributed teams work collaboratively and securely, their platform connects people regardless of their location, allowing them to pass encrypted blocks of content back and forth from desktop to desktop. Though there is a central, Internet-accessible Content Circles server maintained by the company, it's only used to provide directory, policy, auditing and related services.

+ Sitrof

Sitrof has taken this technology and laced in its own regulated data protection and interface with Microsoft SharePoint for the DocExchange tool. This allows collaboration across firewalls and the tracking of content, which again, is never stored anywhere other than member computers. This also means that space isn't a problem, as there are no file-size limits.

Read the entire article  on CMS Wire By Chelsi Nakano | Published Jun 16, 2010

DocExchange is a combination of technology and software from Content Circles and Sitrof.  Content Circles presents a simple, secure content management and collaboration solution that works the way you do - anytime, anywhere, on your own computer.  Sitrof provides a depth and breadth of experience with unstructured content, regulated industries and enterprise rights management. DocExchange is an amalgam of those benefits and creates a premier solution for sharing sensitive and large amounts of content.

"Sitrof takes the Content Circles platform for peer-to-peer document exchange, and with our experience in life sciences and other regulated industries adds the necessary data protection and interface with Microsoft SharePoint to be the most effective, secure, compliant document exchange platform on the market."

- Bryan Reynolds, Managing Partner, Sitrof Technologies

“Sitrof takes the Content Circles platform for peer-to-peer document exchange, and with our experience in life sciences and other regulated industries adds the necessary data protection and interface with Microsoft SharePoint to be the most effective, secure, compliant document exchange platform on the market,” said Bryan Reynolds, managing partner of Sitrof.  “We’ve implemented this solution at Contract Research Organizations (CRO’s) so sensitive clinical trial data and documents can quickly and securely be shared with the pharmaceutical company who commissioned the research study.

DocExchange allows collaboration across firewalls and tracks your content. All content is passed in encrypted blocks for complete privacy and security.   Information is never stored anywhere other than member computers. Large files can be shared with ease because there are no file-size limits.

”Sitrof is a strong ally – they have significant industry expertise that they bring to bear in DocExchange,” said Sri Chilukuri, CEO of Content Circles.  “An increasing number of organizations are looking for an innovative solution like DocExchange to share data as privacy and security concerns continue to escalate.”

Pricing and Availability

DocExchange is available immediately from Sitrof Technologies and their channel partners. Contact sales@sitrof.com for a price quote.

About Sitrof Technologies

The experts in unstructured data for information management, data protection and compliance, Sitrof brings together people, processes and documents to help clients prosper. Backed by decades of experience and world-class partnerships, Sitrof saves companies millions of dollars across many industries, improving efficiency and mitigating risk. To learn more visit http://www.Sitrof.com, email sales@sitrof.com or call 866-545-8954.

About Content Circles
Content Circles is an innovative provider of secure, easy to use collaboration and content management solutions for teams that span departments, divisions and companies. Content Circles is headquartered in Mountain View, CA. For more information, please call +1 650.847.5739 or visit www.contentcircles.com. Content Circles, the Content Circles logo, and the marks relating to other Content Circles products and services referenced herein are either trademarks or registered trademarks of Content Circles, Inc. All other trademarks are the property of their respective owners.

As Appeared in Applied Clinical Trials, March 2010

The 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.1

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 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 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.2

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 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 workflow, 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 Technologies (O'Reilly Media, Sebastopol, CA, 2001).

Dan Wheeler is Managing Partner and Cofounder of Sitrof Technologies, 700 Alexander Park, Princeton, NJ 08540, email: dwheeler@sitrof.com

This article was originally printed in Applied Clinical Trials, March 2010 >> Click here to view

The benefits of peer-to-peer networking over email, fax, FTP, and hosted solutions

The 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. Click here to view entire article in Applied Clinical Trials, March 2010

Sitrof’s DocXhange Solution provides each of your organization’s clients with their own individual workspace, maximizing security and confidentiality by eliminating the risk of accidentally sharing sensitive data with the wrong customer. The DocXhange Solution allows for limitless storage and file size transfer, as the data is stored within the workspace.

Sitrof’s DocXhange Solution encompasses a constantly accessible, peer to peer structured network architecture that allows users to share, collaborate, track and manage data within a permission based, trusted workspace user group. This network architecture ensures your data’s security, as your content is not stored online and can only be accessed by permitted workspace users. Ease of access and operation is a major advantage of the DocXhange Solution, which automatically encrypts and replicates data among workspace users, allowing every user constant access to the latest shared data even if they are not online. Workspace user groups can be comprised of users all from the same organization or users from multiple organizations, and is compatible with both Windows and Mac computers. The DocXhange Solution is also capable of integrating with an organization’s existing ECM system, allowing data to be easily and securely shared with people not inside the enterprise.

Sitrof’s DocXhange Solution tracks and manages your data in several ways, including email notifications, status update indicators and file status tabs. This increased ease in data management allows for workspace-wide real time interaction and updates. Workspace users can set preferences to have email notifications automatically delivered to each user when data is added or altered. Additionally, status update indicators are displayed to alert users of new, unseen updates within the Workspace application. Each file is also tracked with a file status tab, which allows users to view any alteration made to the file by all users in the Workspace.

Key Benefits:

• Instant, real-time collaboration optimizing structure and organization between all workspace users
• Limitless file size sharing and storage
• Secure data management controlled solely by the Workspace’s owner
• No IT involvement required. No changes to the IT infrastructure are required (hardware or network settings) and users can easily create their own workspaces
• Each company you work with will have their own individual workspace so there is no risk of having the wrong document go to the wrong customer
• Email notifications can be sent whenever new documents are added or existing documents are modified
• Costly third-party hosted solutions are not required
• Works with Windows and Mac computers and integrates with existing ECM repositories