Octagon Research Solutions Inc. Data Standards Organizations that hesitate to embrace these standards as opportunities will be at a competitive disadvantage. They will continue to struggle with the tactical “cost” of transforming the way they do business. Monique Garrett VP, Marketing Tom Guinter VP, Clinical Data Strategies The biopharmaceutical industry is witnessing the rapid evolution of multiple data, document, and submission standards that impact the regulatory submission, review, and approval process. The implementation of standards, such as the various models set forth by the Clinical Data Interchange Standards Consortium (CDISC), are effectively changing the way the industry does business. These new models provide organizations with a unique opportunity to develop consistency across programs, functions, and individuals. In doing so, organizations can achieve unparalleled performance improvement in areas traditionally thought to be too disparate to standardize. The Need for Standards Organizations that take the traditional wait-and-see approach and view standards as a series of compliance issues miss out on opportunities to transform their business. The implementation of data standards is primarily an opportunity to improve performance across a collection of processes, people, and tools. The benefits of standards are immediately apparent yet often overlooked. As an organization looks for new ways to squeeze additional efficiencies out of a process, standards become an essential part of a larger performance improvement strategy. Standards are the enablers of change in an evolving business/industry. Overcoming the Challenges Organizations that hope to implement clinical data standards are often challenged by the initial investment costs associated with the transition activities. These costs include process redefinition, education on new tools and new standards, and potentially the acquisition of new technologies. Yet, the cost of not implementing such standards is far greater. Information barriers that develop between functions can be significantly decreased as standards are implemented. Incremental and recurring savings add up as an organization employs and reuses standards. The initial investment can be quickly recaptured through new efficiencies that cascade through the organization. If standards are implemented in large complex processes that span functional areas, the savings are multiplied as cross-functional processes are aligned and optimized. As a company develops its clinical data strategy, it is paramount to address preexisting or legacy data, as well as incoming or future data. Depending on the pipeline and timing, conversion of legacy data may be even more critical to the successful completion of a project than developing capabilities to support new data. In addition to legacy conversion, education on the standard being implemented is also important. R&D professionals need to know how the standard will be implemented, the impact on all affected processes, and any new technologies required for success. If this sounds a bit overwhelming, remember that there are other ways to obtain capabilities that do not require a significant up-front investment. Strategic outsourcing on an interim basis offers immediate capabilities while limiting the capital investment and internal resource requirements. This method allows an organization the luxury of time. It frees up internal resources to focus on learning a new standard and ironing out all of the details of implementation before going into production. Simultaneously, a knowledge transfer program may be implemented to enable internal resources to learn from the practical experience of the outsourcing partner. When outsourcing is part of a well-developed strategic plan, the outsourcing partner also can address organizational barriers to help market/sell internal skeptics on the advantages of the standards while federating individuals into the implementation process. Evolving Data Standards Evolving data standards such as the CDISC SDTM (Study Data Tabulation Model) also will continue to overlap with converging submission standards such as the electronic Common Technical Document (eCTD). The convergence of these standards represents the industry’s shift from paper processes to automated electronic processes that support electronic submissions and electronic reviews. Opportunities for automation in the drug-development life cycle drive performance optimization and also can span the full life cycle of the review and approval process. As the standards converge, new opportunities for greater efficiency and accuracy will emerge. Organizations that hesitate to embrace these standards as opportunities will be at a competitive disadvantage. They will continue to struggle with the tactical “cost” of transforming the way they do business. Conversely, organizations that implement these standards will begin to discover new models for efficiency. Early adopters will be positioned to take advantage of these recurring efficiencies and will begin to reap the benefits immediately. Octagon Research Solutions Inc., Wayne, Pa., is a leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life-sciences industry. For more information, visit octagonresearch.com. June 2005 VIEW on Clinical Services
