Princeton, NJ, January 21, 2011- Sitrof Technologies, a company that provides premier consulting and technology solutions, announced today that they will be attending the DIA Electronic Document Management 2011: The Intersection of Data, Documents and Submissions Conference (DIA EDM).

DIA EDM will take place in National Harbor, MD from February 15-17, 2011. The Conference has served as a forum for the discussion of emerging standards and the processes for the creation, submission and retention of regulatory information. This year’s program has been enhanced to provide a more comprehensive and interactive experience. The renewed approach affords opportunities to learn about and discuss the benefits and challenges of global standards development and implementation. Please come visit Sitrof at booth #205, as we have some exciting new offerings to make document management and compliance a snap.

"We are excited to have the opportunity to attend this year’s conference," says Bryan Reynolds, managing partner and co-founder of Sitrof Technologies. “Stay tuned for an announcement of a new offering for life sciences to streamline the management of marketing and promotional materials.”

About Sitrof

Founded in 1999, Sitrof Technologies is a privately held profitable company with headquarters in Princeton, NJ, and offices in San Francisco and London. Sitrof Technologies has earned trusted advisor status with an expanding repeat customer base of over 200 leading enterprise and emerging mid-market companies. 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 DIA EDM

Over the past 23 years, DIA EDM strives to teach participants to recognize the challenges and complexities of globally managing information, explain the importance of aligning standards, technology and leveraging interoperability, recognize the vital role of metadata in the intelligent management of data, documents and submissions as well as identify trends and standards in electronic records. To learn more about DIA EDM visit http://www.diahome.org/DIAHome/Home.aspx.

Together they transformed CGIRB from an entirely paper-reliant company with millions of pages of legacy documentation into a completely digital paperless organization. CGIRB chose Sitrof to handle this project because of Sitrof's specialty in unstructured data management and extensive experience in FDA 21 CFR Part 11 compliance. Sitrof installed Xerox DocuShare and the Sitrof Compliance Module to automate the workflow and decision process; to improve efficiencies and customer service; all while remaining compliant. The benefits of going paperless have been numerous for CGIRB and the clinical trial sponsors they work with on a daily basis. Most notably, the solution, which ties into CGIRB’s proprietary Protocol Tracking System (PTS) has sped up their review process and given clients real time access to status and documentation through an enhanced web portal, Connexus. The article, which notes CGIRB's large donation of paperclips to local schools, also touches on CGIRB's evolution as a greener, more efficient company.

"Taming the Beast," is in the November-December 2010 issue of Bio IT World and can be read online here.

The full Copernicus Group IRB Case Study can be read here.

A global pharmaceutical company and Sitrof client uses FirstDoc R&D for managing their FDA submission content.  After acquiring another life sciences company that were left with submission content in three disparate content repositories; one in FirstDoc and the other two lightly customized versions of Documentum. The company tasked Sitrof with defining the migration mapping requirements, evaluating configurations and customizations in the source system and implementing a technical solution in order to migrate this mission critical  content and metadata.

Key points to consider when performing such a migration include:

• FirstDoc Object Model
• Migration of FirstDoc Configurations
• FirstDoc API
• FirstDoc Migration

FirstDoc Object Model

When performing a migration from one FirstDoc system to another, it is important to remember that FirstDoc interfaces rely on the FirstDoc object model to function correctly. The FirstDoc object model for the FDRD module is reproduced below:

All objects that extend from the fdk_document type are recognized by the FirstDoc interface to be FirstDoc documents. If types are to be mapped from one FirstDoc system to another, this is important since mapping to a type that does not extend from fdk_document will cause the document to become a normal non-FirstDoc document.

Properties of the fdk_document in all FirstDoc:

FirstDoc extends the Documentum Type architecture to Subtype, Unit, and Subunit. Thus, a mapping of the Types, Subtypes, Units and Subunits is required from one system to the other. This is usually achieved in the requirements gathering phase, after mapping has been decided upon. Furthermore, each FirstDoc module has other special mapping requirements which are unique to each module. For example, in the FDRD module, all FirstDoc documents extend from the r_and_d_document type which has the required attribute ‘product’. Each unique product is associated with a Product Dictionary in the FDRD system.

When migrating from one repository which has a different set of products to another, all product dictionaries must be created from the source system in the target one. Products may also be mapped from the source system to the target one in which case a new product dictionary does not need to be created. This is illustrated below:

For a successful migration of all documents, all products must be completely mapped or created in the target system since the FDRD module will not allow documents to have products which do not have a Product Dictionary.

Migration of FirstDoc Configurations

FirstDoc is a client-driven enforcement of server-side configurations, meaning that all FirstDoc rules and security are enforced at the Web layer. The rules are implemented and stored in the Content Server. Every FirstDoc configuration is associated with at the minimum a Type and a Subtype and at maximum the Unit and Subunit.

During migration, this presents us with two scenarios:

• All Types and Subtypes are mapped completely from the Source System to the Target System. In this case, migration of FirstDoc configurations might not be necessary--unless the configurations from the Source System to the Target system are in conflict with each other. In this case, the business owners of the source system and the target system must decide which configurations to keep.
• Some Types and Subtypes from the Source system are created as new Types and Subtypes in the Target System. In this case, the configurations associated with these type-subtypes might have to be migrated to the Target System. These new type-subtypes must also be added to the FirstDoc Dictionary of the Target System. To assist in the migration of the configurations, the FirstDoc CMU Tool could be employed.

FirstDoc API

FirstDoc provides developers with an extensive set of JAVA API to perform many of the server-side functions that are executed upon user-interaction. For the purposes of migration, only the API related to the following two functions are important:

• Refoldering API: Documents in FirstDoc are foldered according to their Type and Subtype. This is stored in a FirstDoc configuration. During import of the documents, one must run the Refoldering API so that the documents are foldered at the right place.
• Security API: Documents in FirstDoc inherit their ACL according to their Type and Subtype. This is also stored in a FirstDoc configuration and during import of the documents, one must run the Security API so that documents attain the correct ACL according to the FirstDoc rules.

The flow of the Import program is thus illustrated as below:

FirstDoc Migration

This section summarizes all the above points and provides a visual for the overall FirstDoc Migration:

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

"Sitrof began our website refresh to enhance our customer experience with coherent organization and superior functionality," said Bryan Reynolds, Managing Partner, Sitrof Technologies. "We have added 'Insights' articles as well as a bank of technical resources and white papers that are easy to search and sort through to help you find the answers to your unstructured data chaos."

The new website articulates the expertise Sitrof brings to unstructured data management by controlling and protecting unstructured data in order to achieve compliance. The website effectively captures the dynamic nature of the company in an attractive and accessible manner.

Download Solutions Brief - Data Topology Mapping Services

As long as the trouble seemed limited to managing storage, then it was a problem the corporation was content to live with. No one was particularly concerned about what was contained within all of that digital storage, and over time even the original owners of this electronic content forgot about it or moved on. So IT made do with additional storage devices and long-term tape-based retention. But then the eDiscovery process blew up in corporate faces, and the problem of unstructured data management blew up right along with it. eDiscovery morphed from a cost-of-doing-business process – and a great way for outside law firms to make a lot of money – into a quagmire of missed deadlines, sanctions, and multi-million dollar review costs.

Then the financial meltdown came along to complete the disaster, turning the regulatory atmosphere from complacent to threatening. The first change threatened the General Counsel’s office (GC); the second change threatened the Governance, Risk, and Compliance officers (GRC). These groups are starting to look to IT to fix the problem, but IT cannot do it alone. What this difficult situation needs is a technology that cost-effectively manages enterprise-wide unstructured data, and then customizes data delivery and actions for specific business processes. Its primary driver is the eDiscovery process, but the common platform enables effective management for GRC and storage management as well. In this Technology in Brief, we will share our take on the promise of these platforms, and how StoredIQ is fulfilling that promise.

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