At a March 27 event organized by American Chamber of Commerce in France and sponsored by Hogan Lovells, CNIL chairperson Isabelle Falque-Pierrotin said that the proposed new European regulation represents a “new paradigm” for business, because it will share the load of regulation between businesses and data protection authorities.  Other speakers, including the EU Data Protection Supervisor and an official from the US Embassy in France also provided insights.

Here is a video of the keynote speech by CNIL Chair  Isabelle Falque-Pierrotin, at the AmCham France, EU General Data Protection & Privacy Regulation Conference on 27 March 2012 

Here is a video of EU Data Protection Supervisor Peter Hustinx at the  27 March Conference, commenting on "accountability" and consent. 

Here is a video of US Embassy in France Minister Counselor Wendela Moore on the White House privacy program and on the "long history" of privacy protection in the United States. 

More on what Mme Falque-Pierrotin said at the gathering....

Co-Regulation:  Falque-Pierrotin said “co-regulation is the good answer,” indicating that the CNIL has already been applying the accountability principle: French law has already provided for the possibility to name data protection officers (DPOs) in companies, the CNIL has begun delivering privacy seals in connection with auditing and training procedures, and the CNIL has been the champion at a European level for binding corporate rules (BCRs).

 Compliance Pack: Falque-Pierrotin indicated that compliance will be the biggest issue for businesses over the coming years, and that the CNIL was preparing a “compliance pack” to help businesses implement effective compliance programs. The pack will be based in large part on the CNIL’s existing practices in BCRs. 

EU-US Convergence, But Issues With US Approach:  Although the US and the EU are converging in terms of substance, Falque-Pierrotin cautioned that significant differences in approach still exist. She commented that President Obama's Consumer Bill of Rights would not be binding without legislation, and that the codes of conduct would only be mandatory for companies who choose to sign them. Falque-Pierrotin expressed skepticism regarding self regulatory frameworks.

Sanctions:  “Sanctions should be adjusted depending on whether a company has implemented accountability mechanisms” said Falque-Pierrotin, recommending a sort of “leniency program” similar to what exists in competition law.

Problems with Centralized Approach:  The CNIL chairperson criticized certain aspects of the proposed regulation’s “one-stop shop” approach, indicating that the extremely centralized approach may not be well adapted for all businesses, particularly bricks-and-mortar. Finally, Falque-Pierrotin expressed her vision that BCRs should not be looked at as simply a tool for transferring data within the corporate group, but rather as a global compliance architecture that would permit transfers not only within the group but with other entities. The CNIL is working with the Department of Commerce to identify “points of interconnection” between BCRs and the US's vision for cross-border data transfers.

For many drug manufacturers, billions of dollars ride upon their ability to conform to the new Extended EudraVigilance Product Report Message (XEVPRM) standards – and do so by July 2, 2012.

Top regulatory information management systems – like Aris Global’s Register and Liquent’s InSight – will eventually support XEVPRM organically, making compliance with EVMPD relatively similar in scope to meeting the old requirements. But for now, the lion’s share of responsibility for EVMPD compliance falls on the MAHs themselves, who must prioritize products, verify and enter massive amounts of data and manage submissions, all with the July 2 deadline looming.

Sitrof is the answer

Who can they trust to help? Who can combine EVMPD experience with the kind of proven technological know-how and problem-solving expertise that can make the transition to the new EU standards easy on MAHs?

Sitrof Technologies is the clear choice. With decades of experience creating world-class content management, process harmonization and compliance solutions, Sitrof has proven itself an invaluable partner to leading and emerging life sciences companies. And as furor has grown over the EVMPD mandate, Sitrof has once again stepped to the plate, providing best-in-breed solutions and invaluable consultation on EMA regulations.

Proven know-how. Revolutionary solutions.

Soon after the EVMPD mandate became law, Sitrof was approached by one of its life sciences partners – a major drug manufacturer with a significant presence in the EU market. With hundreds of product variations available in Europe, the company faced the prospect of needing to dedicate tens of thousands of man-hours to compliance – or losing billions in revenue.

Trying to meet the new EVMPD requirements by blunt force was not an option. The drug manufacturer needed a better way. And Sitrof was there to develop one.

Within months of the EMA mandate, Sitrof had developed a system leveraging Microsoft’s SharePoint and InfoPath solutions to build screens enabling users to interact with EVMPD XML schema definitions. The Sitrof solution also included workflow functionality, as well as dashboards for measuring submission progress.

But EVMPD compliance is much more than simple data entry. The information required by the EMA mandate is often scattered in a RIMS, and routinely needs cleansing, quality review and verification. In creating an EVMPD solution for the major drug manufacturer, Sitrof leveraged its years of data management expertise to create a system that identifies EVMPD-necessary data, extracts it, cleanses it and readies it for submission according to the EMA’s XML schema definitions.

EVMPD: There’s no need to panic

While the EVMPD mandate surely represents a seismic shift in European pharmacovigilance requirements, it doesn’t need to be a game-changer for life sciences companies. Compliance won’t be easy for any MAH, and clarifications and tweaks to the new law will almost certainly present unexpected hurdles in the future. But solutions exist. Qualified partners are out there. Now.

Sitrof Technologies is a proven resource for companies struggling to deal with the new requirements. From SharePoint-based data management solutions to trusted counsel on submission prioritization, Sitrof offers proven results for dealing with EVMPD efficiently and effectively.

A merger or acquisition often necessitates the process. But it could be a lack of support for legacy systems, or the increased cost of maintaining old hardware overshadowing the cost of migration. It could simply be the desire to switch to a less expensive document management solution.

In any case, running multiple document management systems parallel to one another is not an option – such a situation is confusing to end users, resulting in a productivity drain. Plus, IT expenses skyrocket as maintenance time increases and hard costs rise.

Analyzing processes, planning the transition, getting buy-in from staff, implementing the changes – who can companies trust to get it done right the first time? For more than a decade, Sitrof has performed complex migrations for Fortune 100 companies, successfully migrating content from a variety of sources to different target repositories. With a special focus on life sciences companies and regulated environments (including those governed by FDA 21 CFR Part 11), Sitrof is the trusted provider for complex content migrations.

The Sitrof Approach

Backed by years of life sciences experience and world-class software industry partnerships, Sitrof is the industry leader in vendor-neutral system integration services.

No two migrations are the same. Sometimes, an off-the-shelf migration tool – like Buldoser or FME’s migration-center – can get the job done. Sometimes, a custom solution is necessary. Sitrof offers best-of-breed solutions when it comes to either approach – or a combination of the two.

Recently, a large generic pharmaceutical manufacturer needed to migrate a subset of documents from their legacy GxPharma solution to a FirstDoc FDQM 5.0 system. The company elected to use CSC Configuration Management Utility to perform the migration, but a unique set of complicating factors required a unique solution. The GxPharma system was running Documentum version 4.2.8, while the FDQM system was running Documentum version 6.0 SP1. Because CMU 5.0 uses DFC 6.0 SP1 and cannot connect to a 4.28 repository, Sitrof issued CMU 4.2 to perform the export while using CMU 5.0 to perform the import and post-import processing steps.

Essentially, if a company owns a migration utility, Sitrof can use it. If a company does not, Sitrof can custom-create a solution based on need and cost. Any migration is possible – one system to one system, one system to many systems or many systems to one system. With years of experience moving data into and out of FirstDoc, Documentum, SharePoint, FileNet and DocuShare, Sitrof has the wide-ranging expertise it takes to get the job done.

The Sitrof Process

Sitrof-engineered migrations begin with an in-depth discovery process. By first determining the scope of the project and the tools necessary, Sitrof can, in many cases, even offer an upfront fixed price.

One recent merger brought together two leading life sciences companies – with five distinct document management systems between them. Sitrof identified the requirements for migrating each into the target system, and standardized naming protocols and security procedures. By the time the actual migration started, careful planning had mitigated the risk of unpleasant surprises and bottlenecks. In the end, the complex migration and validation of terabytes’ worth of regulated content proceeded smoothly.

Sitrof’s proven process allows it to migrate a company’s data, content and metadata, no matter how many repositories they have or need. Just as importantly, Sitrof guarantees all migrations are performed successfully through strict validation requirements. Whether it’s a large customer with a set migration methodology or a smaller client in need of consultation, Sitrof ensures FDA and EMA compliance, no matter how rigorous the regulatory requirements.

Don’t go it alone

Trying to complete a migration project in-house can seem attractive from a cost and effort perspective – at first. While the actual migration process – moving documents from Location X to Location Y – seems relatively straightforward, what surrounds it is not. A migration is a golden opportunity to streamline and cleanse systems of outdated and unnecessary documents and files. Without the right people, processes and methodology, businesses can struggle to fully leverage the opportunities a migration provides.

Whatever the reason for undergoing the process, Sitrof offers life sciences companies maximum return on their migration investment, as well as proven, trustworthy, validated solutions for all client sizes.

Dan Wheeler is a managing partner and co-founder of Sitrof Technologies, 700 Alexander Park, Princeton, N.J. 08540.

 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.

Email

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

The Summit is meant to take an in-depth look at how the latest technologies are being used to solve critical business issues within the life sciences industry. The event, on September 14 in Basking Ridge, NJ will also cover electronic trial master files and records management in small sessions and discussions.

For more information on the EMC Life Sciences Summit, click here.

Sitrof was glad to hear that DDMAC submissions will be accepted in eCTD format by the FDA by 2012. Our product, Approve-PTS will be enhanced to support this. Approve-PTS, built on Microsoft SharePoint 2010, connects outside creative agencies, marketing teams and regulatory reviewer--allowing marketing materials to get reviewed, approved and published in the most efficient manner possible.

Speaking of Microsoft, we saw their huge display booth along with NextDocs and Liquent – their offerings look good and traffic was high at all three booths. We imagine booth traffic was higher for these vendors since both EMC (IIG) and CSC were not in attendance.

As expected, a lot of sessions and vendors were talking about the cloud. In the content management space, companies like Box and SpringCM are gaining traction but it’s clear the life sciences industry is not ready to put their GxP related documentation in the cloud without it first being validated. Vevva Systems is looking to change that with their Vault solution which is a cloud enabled content management solution built from the ground up with the Life Sciences industry in mind. It will be interesting to see how this solution can compete with traditional on-premise solutions like Documentum and SharePoint

Sodrel’s article is based on CGIRB’s transition to a fully paperless company, a process that started in mind-2008 when CGRIB teamed with Sitrof Technologies to install the Xerox DocuShare software and the Sitrof Compliance Module for DocuShare. DocuShare was first configured to mange CGRIB’s non-regulated documents, such as vacation requests, business development information, training information, PowerPoint presentations, spread sheets, status reports, RFI’s and contracts. After giving the staff time to become familiar with DocuShare, Sitrof installed its compliance module a year later. These systems help to automate the workflow and decision process and improve efficiencies and customer service.

CGRIB was able to transform from a heavily paper-centered company into a completely digital, paperless organization in less than two years. Going paperless enabled CGIRB to become more efficient in all areas, with the added bonus of becoming more environmentally friendly. Sodrel encourages paperless transitions in order to help an IRB quickly collaborate, share documents, and review protocols.

Click here to read the full article.

The session started off with questions raised about the constraints of capture, there seemed to be a high barrier to entry for organizations looking to digitize their essential documents and processes.  To break through the barrier, training and education must be part of the organization. A phased approach is always recommended to optimize success.

I enjoyed the question and answer format of this event. The audience had many questions about finding content - I explained the Sitrof core belief of finding content based on how it’s been indexed. Indexing typically varies from over a hundred fields to a just few fields, but the general rule of thumb is 5 fields.

It is important to classify content and more important to OCR the document so that we enable the powerful search engines to find content. This led to more questions about search. I discussed Recommind and other technologies available which are built on the search engine and are effective in finding content such as contracts and invoices by setting up rules.

Once the audience released how I emphasized how key indexing is to the success of the project, and I conveyed this to the audience. Questions then shifted to how better to streamline indexing - I talked about getting the business process in place by understanding the business first and then finding a solution.

The final area of discussion was e-signatures. I explained the different types of signatures that exist and products such as DocuSign and CoSign. We also discussed the need for a regulatory body to standardize the signature for consistency across the board.

The panel agreed that because of the generation gap that paper still plays a major role in our business. As the younger generation matures, paper will continue to slowly disappear. The panel also agreed that it will take 2-3 decades for a paperless world to become a reality.

Thank you to the AIIM Garden State Chapter for asking me to be a part of this event. I really enjoyed it and it was great to meet everyone there.

Copernicus Group IRB is a paperless office whose shift from being paper-based was led by Sitrof Technologies in a large, three-phase project. This has saved the organization more than $2 million on shipping, printing, postage, and file storage. Sitrof’s installation has translated to CGIRB becoming 98% paperless.

CGIRB was honored by InfoWorld for being one of the most innovative IT initiatives that fall under the umbrella of sustainability. The award honors companies who have embraced green technology to drive projects and develop products aimed at boosting energy efficiency, trimming waste, and reducing or eliminating the use or the production of harmful substances are selected for the Green 15.

CGIRB staff can now digitally search through 5 million pages' worth of legacy documents and process client submissions into the electronic workflow in an average of 3.7 minutes, as compared to 104 minutes in its paper-based era. Less time, money and effort are spent on everyday tasks, making CGIRB more efficient and green, thanks to the Sitrof installation.

To learn more about the InfoWorld Green 15 and read the complete list of winners, please click here.
To read the full case study on Sitrof and CGIRB, please click here.

The paperless install effort that was a finalist in the AIIM Awards is a case study as well. Last week’s Xerox DocuShare newsletter included a video of the case study talking to key players at Copernicus Group IRB. Click here to view the video. The case study details how Copernicus Group IRB hired Sitrof to replace its paper-based pharmaceutical clinical trial review system with DocuShare and became almost 100% paperless, saving effort, time and money. To read the case study in its entirety, please click here.

Bryan Reynolds, managing partner of Sitrof, is looking forward to speaking at the AIIM Garden State Chapter next month – stay tuned for details on this speaking panel event.