MANY PHARMA COMPANIES HAVE AN EDMS, BUT THE INDUSTRY SEEMS TO STILL BE A LONG WAY FROM PAPERLESS. WHY IS THIS?
Gens: While the ideal goal is paperless, the practical reality is that paper will exist for a long period of time. The paperless goal is primarily focused in the traditional high-revenue markets of the United States, the European Union, and Japan; however, this is changing as emerging markets (Brazil, Russia, India, and China) are growing in revenue and clinical trial importance. Extending paperless programs into these regions and other emerging market countries is complex and time-consuming. From an ECM (electronic content management) standpoint, those companies that have positioned their ECM programs from enterprise and global constructs have the best opportunity to easily extend their programs. Additionally, some areas that are currently paper-based are not yet cost-effective to move to a paperless environment (e.g. submissions to health authorities in small countries that do not require an electronic format).
Hirning: In part, this is because of the mindset of the industry. We have used paper for everything and have paper processes that have been time-tested. Moving to a new system in a regulated industry is risky, and these companies prefer to keep risk to a minimum. The other issue is that these companies are not static. They have ongoing studies, processes, and other work that cannot be stopped to implement an electronic solution. The solution has to be developed in parallel with ongoing work by the same project teams who are working on the studies and processes in the paper format. The extra work and change in mindset which is required to develop the electronic system at the same time as working in the paper can create problems.
Lustri: So long as the industry remains in the paradigm of having manufacturing personnel handwriting production information to record quality and compliance information, paperless operations cannot be achieved. Paperless manufacturing is attainable only when the originally executed work process is recorded as a digital transaction. The industry is moving in this direction with the use of electronic batch records, electronic equipment log books, and electronic material tracking applications to support the execution of the work process electronically. Until this transition occurs, the industry will be stuck with an inefficient process or recording the original work process on paper and then scanning the paper into the electronic document management system for long-term archiving.
Smyth: This industry takes a long time to change, and to date there has not been the push by senior management to operate in a paperless virtual environment. People are comfortable with their paper, filing cabinets, face-to-face meetings, etc. that go with working in a larger organization. The movement to a paperless process will continue to occur, and I expect this will happen more rapidly over the next five years with profit margins and solid pipelines shrinking, which forces all companies to work more efficiently. Of course, my guess is that in the long run, this will only help companies compete once more compounds come through the pipeline into clinical development and regulatory submission.
WHAT ARE THE MAJOR STUMBLING BLOCKS THAT CAUSE ELECTRONIC DOCUMENT MANAGEMENT PROJECTS TO BE UNSUCCESSFUL?
Gens: Our 2007 empirical document management study (ILSS/Gens and Associates) found the top hurdles were 1) budget, 2) network capacity and performance, and 3) vendor limitations. Interestingly, our 2009 study found 1) collaboration integration, 2) performance, and 3) improved search capability as the top priorities of change.
Our practical experience tells us that the core challenges are: 1) organizational change (business process and mindsets) and 2) how a program is constructed. Most programs grossly underestimate the people side of change as most potential users espouse or desire the new way of working, but as the project moves from concept to detailed requirements/new business processes, resistance grows. We believe that commitment to a concept is easy; however, gaining commitment to a new way of working is hard (the devil is in the details).
Hirning: One of the major stumbling blocks is user acceptance. Many times, the functional area leaders that specify and purchase a system are only looking at the compliance issues and fail to recognize that failed user acceptance will kill an EDM project in the end. Failed user acceptance can often come from an inflexible system that cannot be adapted to meet the needs of multiple user communities. A system has to be flexible enough to deal with tightly controlled documents as well as uncontrolled documents. Users of the uncontrolled content will be frustrated when forced to face the stringent controls that have been developed for documents like SOPs and manufacturing specifications. The two must be able to coexist with each user group using the functionality and controls that meet their requirements, but no more.
Klein: The most common barriers to successful projects include:
- A technical deployment absent of business process and best practices
- Immature products that cannot meet the strict validation requirements in life sciences
- Closed systems that are unable to integrate with important components such as publishing tools and image capture tools
- Not appropriately positioning electronic document management vs. collaboration
Smyth: Many times, it is due to lack of compliance by end users in using the systems. While the initiative to implement such a system may have come out of the IT group, the operational group may not have bought in to the efficiencies, and once they are doing their day-to-day job, they revert back to their paper files or files on the network. Another stumbling block is due to the complexity of many of the systems. A major advancement in technology, while it may be trying to make things more efficient, may appear to be too complex to an end user who is comfortable using MS Office (Word, Excel, PowerPoint) and PDFs over a number of years. The electronic management systems need to feel familiar to the end users and provide some efficiencies, but gradually pull the end user along as they advance in their knowledge. It doesn’t happen overnight.
WHY IS ELECTRONIC DOCUMENT MANAGEMENT VITAL TO PHARMA OPERATIONS?
Gens: The traditional benefits are supporting time to market (first and multiple), compliance, and instant digital archives. Many of these benefits still hold true; however, an ECM environment built on collaboration can claim process efficiency benefits with key partners. This is rather critical from an operational standpoint, as codevelopment partnerships and clinical trials outsourcing are rapidly growing, and the amount of content exchanged is large and highly proprietary.
Hirning: Pharmaceutical companies have a somewhat unique requirement of making regulatory submissions for testing and marketing approval. With all-electronic submissions becoming mandatory in certain parts of Europe, we should expect them to become mandatory in other geographies. This move to electronic submissions creates a situation where the maintenance of both paper records and electronic records is cumbersome. The efficiencies gained by moving to electronic systems begin to outweigh the costs and energy required to do so. While informal studies have found only modest cost savings in the move to all-electronic submissions, the time savings were found to be significant and provide excellent ROI, especially in follow-on submissions.
Klein: The top two reasons for our customers are compliance and productivity. Document management systems help companies meet regulatory requirements such as eCTD (electronic common technical document) regulations. The proper system with built-in controls and preconfigured with industry best practices helps reduce risk and increase productivity. The risk of noncompliance skyrockets without a proper system in place. In addition, the right technology can improve competitive advantage in the race to get products to market. It can also protect IP in dealing with external business partners.
Lustri: Document control and quality control are inseparable. Documentation is the means used to prove quality, and therefore, if robust document control practices are not used, there are grounds to doubt the entire basis for quality management. For example, if an SOP is modified to be consistent with a revision in the manufacturing process, and personnel accidentally use an old version of the SOP, there is the potential for the procedures used to not be compatible with the new process.
WHICH AREAS OF THE INDUSTRY ARE NEWLY EXPLORING CONTENT MANAGEMENT?
Gens: This depends on the lens to your question. Most large and midtier companies implemented ECM solutions in the 1990s and have had many iterations. Small companies’ hurdles to an effective ECM program were primary economic. This is changing rapidly with low-cost solutions not based on traditional robust and expensive tools and the growing emergence of Software as a Service where the solution is on the Web and not managed internally.
From a content collection standpoint, our 2009 survey found collections such as promotional materials, intellectual property (e.g. patents), and business development content are not fully incorporated into a formal ECM program or are still paper-based. These areas appear to be “next priority;” however, our comparison to our 2007 study shows little movement in deployment of these document collections.
Klein: Given the increase in regulatory scrutiny across various lines of business, we are seeing an increase in inquiries regarding sales & marketing, trial master files, investigator portals, and other corporate areas like legal and finance. The uptick in sales & marketing certainly correlates with the increase in direct-to-consumer advertising on television and the Web. In addition, many large pharmaceutical companies work with external business partners in drug development, clinical trials, and adverse event reporting. Coordinating the submission documents involved is daunting, especially when it’s outside the firewall.
Lustri: Manufacturing organizations are now engaging in EDMS. We are seeing a strong relationship between electronic batch records (EBRs) integrated with EDMS. This enables EBR execution by automatically retrieving from the EDMS the currently effective version of the EBR, and the completed batch record is automatically stored in the EDMS. This creates many efficiencies in how production records are created, executed, approved, and archived.
Smyth: The biggest shift we’re seeing is with support vendors — companies like CROs and IRBs (institutional review boards) — that are realizing that in order to compete, they need to explore and implement content management solutions that can provide information quickly and securely to both prospective and current clients.
DO YOU SEE A DIFFERENCE IN THE APPROACH BETWEEN LARGE BIOPHARMA AND MIDSIZE TO SMALL FIRMS IN THE MOVEMENT TO EDMS?
Gens: Large pharma has embraced ECM since the early 1990s, and many still have highly customized and expensive ECM systems commonly known as “the early adopter curse.” As the vendors started moving to product based on common practices in the late 1990s, midtier companies started to invest in ECM at a significantly lower cost point. Today, the cost of ECM has been reduced dramatically and could go further.
Another dimension to this is the type of deployment. We see from our 2009 study that the top 20 pharma companies tend to have more global solutions, while the midtier has a combination of global, regional, and local solutions.
Klein: Large organizations have been using document management systems for years, the majority of which were costly and highly customized. Currently, with the mandate to cut costs, they are dealing with a significant number of legacy systems and growing global operations; but rather than wipe the slate clean, so to speak, they are looking at more pragmatic approaches that involve less customization and more personalization. For example, secure collaboration portals enable large companies to access highly regulated data from disparate repositories through a user-friendly Web-based portal. That information is delivered in a way that is most relevant to the user’s role — hence, personalized. So, large companies are consolidating and not necessarily trying to achieve a single, universal system. Instead they are opting to leverage new technologies that can integrate with their existing systems.
To some degree midsize companies don’t differ too much from their big cousins. Many of them have made significant investments over the years, but don’t truly have a collaborative, integrated document management system in place. Like big pharma, they may experiment with systems in discrete areas, but it’s hard to get consensus across the various lines of business as to what works best. Smaller companies are more apt to adopt off-the-shelf products, especially those that are preconfigured to meet specific life sciences-related regulatory needs such as 21 CFR Part 11 and specific domain business processes.
Lustri: Small biopharm companies are looking for out-of-the-box solutions for EDMS. They are less likely to select EDMS technologies that require extensive customization, configuration, and IT systems management. Larger biopharm companies are more likely to take advantage of opportunities to combine EBRs with EDMS for production records.
Smyth: Large biopharmaceuticals were some of the first to move toward electronic document management, mostly out of the needs associated with organizing content enterprisewide. Lately we are seeing a definite trend with increasing interest from midsize and small biopharmas and medical device firms moving toward electronic document management. They are realizing that, compared with paper, these systems provide cost and personnel efficiencies that scale extremely well to a small company environment. The end result is that they can divert financial and human resources more fully to clinical development programs.
HOW COULD AN EDMS BE IMPLEMENTED TO STREAMLINE A PHASE II OR PHASE III CLINICAL TRIAL?
Hirning: We believe that a DMS will help a company at any stage in the pharmaceutical development timeline. The central electronic document repository would seem to specifically help the clinical groups in an organization stay on top of the mountains of documentation required to manage and conduct later phase clinical trials. Some of the challenges to convincing the clinical groups to use a system are listed above. However, the ultimate goal of easing the pain of the final submissions should be enough to convince most groups to move to the electronic realm.
Klein: Sponsors conduct numerous trials worldwide. From a document management standpoint, each trial has a multitude of moving parts to manage. A document management system accessed through a clinical portal can help handle those critical touch points and processes. And a portal offers a familiar collective user interface across those touch points. Secure log in enables personalized control over content tailored to specific roles across each trial at its various phases – inside and outside the firewall. Companies save time and money collaborating on and exchanging documentation.
Lustri: By combining electronic workflow tools with EDMS, it becomes possible to assure all steps in a work process are completed per specification and the results are permanently stored with the EDMS.
Smyth: One of the biggest challenges in ensuring that phase II and III studies go smoothly is the costs and logistical challenges of coordinating the multiple different players involved. With investigative sites dispersed all over the world, and partner companies and stakeholders in multiple locations, advanced electronic document management systems allow all stakeholders to view general study information as well as documentation specific only to that particular stakeholder.
In addition, essential document completion can be done online, and documents can be completed through documentation systems yielding a paperless document environment. Proper utilization significantly reduces time to study start up and closeout , as well as resources by stakeholder organization needed to properly execute the study.
WHAT ARE THE SUCCESS FACTORS RELATED TO A MULTI-SITE CORPORATE DEPLOYMENT OF ELECTRONIC DOCUMENT MANAGEMENT?
Gens: Several come to mind: Business process flexibility Consistent policy Understanding of cultural differences to create “best decisions” for the organization Scalability of solutions (technical and the vendor organization) Post-implementation support (business process and technical) – most just focus on the technical Archival strategy and understanding of information across borders limitations
Hirning: The obvious ones, used by vendors for promotion, are the speed at which processes and workflows can be completed. Document approvals and form completion take less time making everyone more efficient. What may be more significant, albeit immeasurable, is the time savings over the long term of having a central identified repository for documents. This removes the search of the document room, creation of copies, shuttling of documents between sites, lost copies of documents and the like. In order to make this time and cost savings a reality, the company needs to be able to create a blueprint of how information flows in the company as well has which people need access to the various types of information. This is critical for the design and acceptance of a system that will actually be adopted by the user community. Without this blueprint of information flow, it is unlikely the system will truly meet the user’s requirements and will probably end up becoming ‘shelfware.’
Klein: Choosing a proven scalable solution is critical. A close runner up is alignment between business and IT needs. Managing timely information-sharing across a multitude of clinical trials and sites is daunting especially given the necessity to comply with regulations such as 21 CFR Part 11. Technology can complicate it further if every interested party is on a different system or still mired in paper based processes. A centralized collaboration area such as a portal that leverages tightly controlled information on the back end while enabling users to create and manage that information on the front end according to user role and geographic criteria can dramatically improve multi-site deployment. It also provides a more economical way to deliver the system while leveraging legacy investments and centralizing disparate areas of information. Better access to timely and relevant information, especially about drug safety, improves decision making, productivity and regulatory compliance.
Lustri: The success factors for multi-site corporate deployments of electronic document management are as follows:
A corporate methodology for deployment should be developed for use at all sites. A base system configuration should be developed that is implemented at all sites. The complete documentation and testing of the base system can be developed with the system being imaged for easy replication at each site. The deployment methodology needs to allow for flexibility to add site specific requirements for each site. After the base image is installed it is revised to reflect site specific terminology and functionality. Corporate resources need to be available to support the site deployment Site resources have to be heavily engaged in the site rollout to assure ownership of the systems after the implementation is complete.
Smyth: The success factors are really related to implementation and end user training so that you can guarantee that people use it. We’re all creatures of habit to one extent or another. The benefits of these systems are there, so encouraging full implementation helps guarantee a positive ROI sooner. It’s actually fairly easy to manage, since the system can maintain oversight and usage metrics that pinpoint users who not engaging with the system. Those issues can be addressed individually, which has proven to be effective. Similarity in user experience is important too, so something that is web-based gives all our stakeholders around the world simultaneous and equivalent access (albeit with different security permissions) and there is much more cohesiveness from site to site.