TranSenda White Paper
Business Process Management and the
Clinical Trial Process
BPM Basics ……………………………………………………………………………..3
BPM and Clinical Trials………………………………………………………………4
This white paper explores many of the issues faced by both small and large life sciences companies when attempting to apply technology to the clinical trial process. It introduces the concept of business process management (BPM) and how this technology differs from traditional software applications. Additionally, it provides examples of BPM applications in the clinical trial process and explains how life sciences companies of any size can take advantage of the benefits provided by this technology.
The drug approval process requires a substantial investment regardless of your organization’s size. The importance of drug safety and efficacy validation is the same whether you have the financial resources of a major pharmaceutical company or those of a biotechnology startup. This paper addresses how a BPM-based clinical trial technology empowers the smaller life sciences company with the ability to grow and integrate clinical trial processes throughout the company’s lifecycle when and where needed. Additionally, it discusses how this technology can help established organizations integrate their clinical trial processes throughout their enterprise, extending system functionality and optimizing workflow. Due to limited technology and IT staff resources, many small companies in early phase trials rely on the expertise and resources provided by outsourced providers (CROs). These services, while expensive, are still preferable to the time-consuming and often distracting process of building an internal clinical trial process and data tracking infrastructure. Many organizations at this stage prefer to dedicate their limited resources to drug discovery and development, not IT systems support and training. As these companies grow and their participants move to later-stage trials they are more likely to be in a position to hire a larger IT staff and acquire systems capable of supporting certain clinical functions. Unfortunately, due to a lack of sufficient or flexible entry level clinical trial support applications, organizations are often forced to do one of the following:
1. Purchase enterprise systems designed (and priced) for companies withbroader needs and greater support resources.
2. Purchase less expensive, shrink-wrapped applications that often fail to provide any measurable benefit due to lack of features or configurability
3. Develop custom solutions. This approach not only taxes existing resources, but can also result in systems with limited functionality and expandability and, unless properly documented, can be crippling if those who wrote the application leave the company. As a sponsor’s needs continue to grow so too do their clinical and operational system requirements. At this point sponsors are faced with the often impossible challenge of integrating the various systems they’ve purchased along the way. Because nearly all existing clinical support applications were developed using proprietary, hard-coded methods, integrating them often requires the services of third-party integrators who employ custom, and expensive, approaches to “glue” applications together. What sponsors are left with is a multi-vendor patchwork of systems and custom code that costs a fortune, drains untold amounts of IT and cross-functional resources, and is nearly impossible to modify. Is it any wonder sponsors are reluctant to implement software solutions?
So what’s the solution?
The industry is crying out for solutions that can mirror their own life cycle and development processes. Systems that can start small, addressing the needs of sponsors at a particular time and that are easily extended. Systems that are flexible and quickly modified, not just in look and feel, but in their core logic and functionality. And systems that quickly and natively integrate with other clinical and cross-functional applications such as those employed by Manufacturing, Accounting, QA, and Sales & Marketing. Sound too good to be true? Until recently it was. Many in the Life Sciences industry are still unfamiliar with a new application paradigm that is rapidly being adopted by other industries to solve their process challenges. This paradigm is commonly referred to as Business Process Management (BPM).
“BPM is the general term for the services and tools that support explicit process management (such as process analysis, definition, execution, monitoring and administration).” 1 To understand BPM, we must first understand what a “business process” is. For the purposes of this discussion, a business process is defined as the “process by which information (data) is transformed as it moves between systems and individuals to provide a desired result for the business.” For example, ordering and fulfilling a book at an on-line bookstore involves the interaction of numerous systems and people, but can be considered an end-to-end business process. Consider that standard software applications are made up of hundreds of modules, linked together by the software vendor to provide a specific set of functions. Further, consider that these “silo” applications are dispersed throughout an enterprise, all dependent upon multiple software vendors. Modification to the “wiring” of these functions has to be done by the software vendor, requiring development time and an expensive upgrade on the part of the customer. Imagine if it were possible for a business analyst, or “process designer” without programming expertise to link these software modules together using a graphical tool to implement a business process. No software code needs to be written to achieve this increased functionality. Business processes could be quickly added or modified as dictated by business needs, as opposed to being tied to a vendor’s upgrade schedule or a lengthy internal development cycle. This is what TranSenda’s BPM technology provides – the ability to build out processes as the business evolves. To achieve their inherent flexibility, BPM solutions are often based upon servicesoriented architecture and open standards, such as XML. Some offer preconfigured components. “These tools are also targeted at increasing the efficiency of a specific application by enabling systems to work together better.”2 TranSenda is the only BPM vendor to offer preconfigured libraries of “process modules” for health care and life sciences. Furthermore, by enabling its users to “plug-and-play” these modules in various combinations and then customize them with their own proprietary business rules and processes, TranSenda provides its customers with an unprecedented level of control and ownership.
1 A BPM Taxonomy, Creating Clarity in a Confusing Market, page 1, Gartner Group, May 29, 2003
2A BPM Taxonomy, Creating Clarity in a Confusing Market, page 4, Gartner Group, May 29, 2003
BPM and Clinical Trials
So what does this have to do with clinical trials? Clinical trials are business processes that involve the coordination of data throughout the organization. Of course, there are special requirements in terms of auditing, security, and data integrity that also ust be taken into account. But, a BPM-based clinical trial solution that incorporates these special requirements will provide a platform from which clinical trial processes may be added as the organization grows, and as requirements are understood. This contrasts with having to commit to a system that may not meet future needs, especially in terms of integration with the rest of the organization. Let’s consider an example. A small biotechnology company currently uses a paperbased clinical trial process and they are approaching the increased data throughput of Phase III of their trial. They want to begin by automating their selection and registration process, and controlling their paper-based processes. Using BPM-based clinical trial software, the registration and selection rules can be implemented and updated with a graphical editor, much like building a high-level flowchart. Business processes to route scanned documents for review and approval can also be implemented in the same fashion. As the company’s needs grow, an EDC business process can be added. For those who have already invested in a clinical trial system, BPM-based platforms provide a means to interconnect with other enterprise systems. For example, a situation may occur where a biopharma embarks upon trials for other indications, requiring coordination of clinical trial processes with commercial manufacturing and drug delivery applications. This requires the coordination and movement of data between the clinical trial system, a logistics system, and an ERP system, which can all be defined as business processes. The leading EDC vendors have built impressive applications and many offer what they call integrated suites. However, by nature of their hard-coded, applicationcentric design, the reality is that these applications are unable to be seamlessly integrated across the suite, let alone the company’s entire organization. In the situation cited above, the company will likely have to wait for their vendor to upgrade its offering or resort to a custom development project. Application or datacentric systems are simply not designed to be agile, whereas rules-based BPM solutions are. This situation begs for BPM, especially if that platform is designed specifically for clinical trials.
A process-centric clinical trial system with BPM provides the optimum infrastructure to manage and control critical business processes, and integrate with enterprise systems. Applications and business logic can be built out as needed by the organization. TranSenda is one of only a select few that has taken a BPM platform and adapted it for use in the Life Sciences market. Over the last two years, we’ve collaborated with many of the industry’s largest players to create application libraries as well as process and interface templates that bridge the gap between marketsavvy traditional clinical support applications and powerful, but market-agnostic pure play BPM vendors. The result is an industry-focused solution with flexibility and expandability that outperforms anything currently available in the market.