Automating document-centric business processes enables staff, partners, and government regulators to focus on collaboration, not administration.
Dec 2005 / Jan 2006 | Strategies to improve business process management (BPM) and accelerate time-to-market go hand-in-hand for biotech and pharmaceutical companies. After all, introducing successful new treatments can boost a company’s revenues by more than a million dollars a day. Faster approval and introduction of treatments also extend the time companies have to recoup their considerable R&D investments.
In many ways, pharmaceutical and biotech companies have been addressing BPM issues for years, adopting solutions that securely automate data analysis, transaction processing, and the rapid transfer of information from one enterprise application to another. Yet, with much of product R&D and approval depending on dispersed staff, outside clinicians, and government regulators exchanging and reviewing documents, companies need to improve how business documents are managed and processed.
Despite advances in BPM, research materials on paper remain a primary way of sharing information across project teams and with outside partners and regulators. No matter how fast back-end systems can process data, delays can occur as clinical trial documents are faxed, or copied and sent from one location to the next. Staff and regulators can also spend hours searching through boxes of materials to find all supporting R&D documentation -- clearly an ineffective use of time.
Fortunately, new technologies are addressing the importance of automating document-centric workflows at the front- and back-end of business processes. As a result, employee interaction with enterprise systems is streamlined, and people can collaborate more easily and securely inside and outside a company. One way to look at the automation is to view documents as a “human gateway” to participating in business processes, with the goal of moving to more integrated digital processes built around “intelligent documents.”
Intelligent electronic documents are similar in appearance to paper and are also easy to use, but the similarities end there. The interactive, digital documents can contain built-in features for automatic routing to one or multiple reviewers, for verifying that forms are filled out completely and properly, and for supporting document control and security. For instance, using built-in features in PDF documents, a company can control who can open materials, limit how long digital documents are available to recipients, and track who tried to access materials.
In addition, unlike manual document processes traditionally used in R&D, intelligent document processes support digital signatures for streamlined approvals and for ensuring that approved materials are not altered (because changes to documents invalidate digital signatures). For pharmaceutical and biotech companies, these controls are vital to protecting intellectual property.
Intelligent Documents in Business Processes
Adopting more automated document processes for R&D and approval is already under way. Government agencies such as the FDA currently accept new drug applications (NDAs) in platform- and application-independent PDF files. Electronic submission of digital documents can substantially reduce the time needed to distribute and review lengthy applications -- and this is only the first step. In addition to streamlining document delivery, pharmaceutical and biotech companies are using intelligent documents to improve collaboration, reduce operating costs, and boost document control and security.
When automating business processes with intelligent documents, there are several issues to consider, including establishing document control and security to protect intellectual property; supporting collaboration across groups inside and outside a company; and using intelligent documents to extend the value of enterprise systems, such as enterprise resource planning (ERP), enterprise content management (ECM), and customer relationship management (CRM).
Gaining control over intellectual property is essential to research. Years of work and tens of millions of dollars go into developing and gaining approval on new treatments. With volumes of information exchanged among research staff, clinical trial investigators, government agencies, and others, documents have to be protected.
By converting materials to secure PDF files, companies have more control over who views information and how long people can access it. Also, varying levels of controls can be established to accommodate the different needs of researchers. For instance, clinical trial managers might only be able to retrieve a limited set of data from a database and submit information in predetermined form fields. In contrast, senior researchers within a company might be permitted to digitally sign materials, add electronic comments to documents, print them, and take excerpts of studies for reference in other materials.
Collaboration is central to developing new treatments, as many groups inside and outside a company offer input as part of R&D and approvals. Dispersed project teams can use intelligent documents to support efficient, virtual collaboration. The compact files are readily available to researchers and reviewers anywhere at anytime. In addition to being easy to access, intelligent documents support automated routing, electronic commenting, and digital approvals, helping ensure that materials move quickly through review processes.
If reviewers are delayed in viewing materials, electronic alerts can be sent automatically to team members. The documents are then forwarded instantly to others who can view comments from previous reviewers. Once approved, documents and comments are returned to originating research teams, where changes are incorporated and feedback is archived for future reference.
Information in ERP, ECM, and other enterprise systems is important to employees and partners. Unfortunately, security issues often make these systems off limits to potential users. Using intelligent documents, companies are enabling employees and authorized partners to securely retrieve data from and submit data to enterprise applications without jeopardizing content in those systems.
For pharmaceutical companies, the automated exchange and updating of information improves the quality and timeliness of collaboration across project teams. For example, intelligent document processes can support anything from overseas research facilities ordering supplies to physicians entering trial data into electronic forms linked to clinical databases. This eliminates the costs and delays previously spent routing and copying paper and the problems with having staff manually enter data into systems.
By expanding their view of BPM to include document-centric workflows, biotech and pharmaceutical companies are improving how employees work with each other, with key partners, and interface with enterprise systems. With intelligent documents supporting BPM, organizations are reshaping traditional approaches to collaboration to better protect intellectual property, streamline R&D, and accelerate time-to-market for new products.
Melonie Warfel is director of life sciences, Adobe Systems.