The benefits of peer-to-peer networking over email, fax, FTP or hosted third-party services
The need for life sciences companies to collaborate with external partners, whether it’s Legal Counsel, Contract Research Organizations (CRO’s), Manufacturers or Joint Venture partners, has become a daily occurrence. Documents such as Contracts, Informed Content and Protocols require authoring, review and approval from individuals both inside and outside the company. This trend will continue as life sciences companies increase outsourcing efforts at the same time the amount of unstructured content generated each year skyrockets.1
There are many different use cases in the clinical trial process that require the need for this type of data exchange. For example, Investigator’s Brochures (IB) are exchanged between study sponsors, investigators and Institutional Review Boards (IRB). These are not static documents thus requiring collaboration as updates are needed whenever new relevant information is found during a trial. Creating, reviewing and approving Informed Consent language requires a collaborative process that involves input from investigators and IRBs. Investigators are required to complete a Form 1572 along with a summary of their qualifications (typically a CV) and provide it to the sponsor before participating in a trial.
Documents such as these are vital to the safety and efficient operation of a clinical study. 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
Challenges with Common Document Sharing Methods
Many CROs and life sciences companies today collaborate and exchange content either through email, fax, File Transfer Protocol (FTP) or hosted third-party solutions. Each of these methods has its 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 in the corporate world. However, sending attachments through email 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 the fact that there is often confusion about which version of the attachment is the latest—a problem that is exacerbated as the number of collaborating users increases. The end result is a time-consuming, frustrating and error-prone process of manually merging multiple documents to ensure the latest edits and comments are incorporated into a single document.
Fax
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 file is not an editable document and is unsuitable for this purpose.
FTP
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 to use and typically require IT involvement to initially set up and configure permissions and access. Security aside, the lack of version management is as much a problem with FTP as it is with email.
Third-Party Solutions
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 particular document and have greater insight into how the document has changed throughout the collaborative process. However, not all on-demand solutions offer versioning features, including one of the leading solutions on the market. 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. This in turn leads to security and compliance issues—for example, users have been known to write passwords on a sticky note and keep it under their keyboard.
Peer-to-Peer Data Sharing: The Ideal Solution
The drawbacks associated with all of these methods—some of which are quite serious—has escalated the need to find a more secure, cost-effective and user-friendly way to manage documents. The solution at hand is peer-to-peer data sharing, one of the most effective content delivery methods available today. Peer-to-peer is an approach to computer networking where all computers share equivalent responsibility for processing data.
Of course, there is one critical consideration to make when selecting a document exchange and collaboration solution: Above all, it must be easy for the end-user to use. This speeds adoption of the new process, avoids costly upfront and ongoing training costs and eliminates the all-too-common scenario where end-users revert back to using email to share documents.
Lower Cost, Improved Performance
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.
Peer networking significantly reduces technology costs for file sharing while dramatically improving the performance and scalability of the document creation, maintenance and review process. It allows organizations to seamlessly add speed and efficiency for content collaboration, while requiring no changes to the business's current technology infrastructure. This greatly improves the end-user experience and securely speeds up the process of document collaboration for both internal and external parties.
In a peer networking solution, desktop computers can easily 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.
Improved Security
Because trial-related documents contain proprietary information and/or sensitive patient data, improved security is a must. For example, if a CRO is working with three separate life sciences companies, it is important, from both a compliance and contractual standpoint, to have three separate workspaces to reduce the risk that a confidential document from Life Sciences Company A is not seen by Life Sciences Company 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.
Accurate Version Control and Tracking
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 interface. This allows for real-time interaction and updates among users, ensuring a more efficient and accurate collaboration process.
Cost-Effective Infrastructure
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.
Integration with Existing Document Management Systems
An exchange and collaboration solution should allow for integration with an existing document management system. For example, take the scenario where an Investigator’s Brochures (IB) 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 (DMS) such as Documentum or SharePoint where it can go through a formal approval process with electronic signatures. When the IB needs to be modified at a later date, a change request should be submitted, and once approved, the IB should seamlessly be copied back into the collaborative workspace. Then the IB can be modified by all relevant parties. After the IB is revised, it should be moved or published back into the DMS.
Universal Platform Support
As the Apple Mac is gaining popularity in the corporate world, any peer networking solution should be innately compatible with both Windows and Mac computers.
Conclusion
The most common methods of document sharing and collaboration in use today—predominantly email, fax and FTP—are inadequate and insecure. Expensive managed third-party solutions may also be insufficient, particularly for highly regulated life sciences needs.
A good peer networking solution, on the other hand, will allow life science companies and CROs to balance multiple factors such as total cost of ownership (TCO), ease of use, robust version control capabilities, auditing and integration into a true document management system. The end result: a comprehensive solution with improved workflow, 21 CFR Part 11 compliant electronic signatures, change management and records retention capabilities.
Life sciences companies that adopt peer networking will experience improved document exchange and collaboration processes with external business partners. This reduces risk, compliance and security issues, while at the same time promoting efficiencies and cost savings. CROs that offer robust exchange and collaboration solutions using peer networking also stand to gain a competitive advantage while providing benefit back to their life sciences customers. In turn, these customers will be able to launch products faster because the document-intensive clinical trial and submission management processes are streamlined and made more secure.
1 J. Malek, Transforming Life Sciences: The Connected Life Sciences Company,
Cisco Internet Business Solutions Group (IBSG), July 2009
2 Peer-to-Peer, Harnessing the Power of Disruptive Technologies, March 2001
Dan Wheeler is a managing partner and co-founder of Sitrof Technologies, 700 Alexander Park, Princeton, NJ 08540
