Rethinking Document Sharing

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 President and Cofounder of Sitrof Technologies, 700 Alexander Park, Princeton, NJ 08540, email: [email protected].