Nov. 26, 2007 | Over the past eight years, more than a dozen biopharmaceutical companies have gone into production with the technology platform and products of Cambridge, MA-based Waban Software. The list of Waban enthusiasts includes Genzyme, which credits the Waban Statistical Computing Environment (SCE) with helping it improve the quality of its drug development work while simultaneously gaining time and efficiency advantages.

Genzyme went live with Waban SCE in August, and three products have already migrated into it, including a large Phase III program, a post-marketing registry, and a few early stage trials, says Dana Soloff, Genzyme’s director of statistical programming. Waban SCE is also in the early stages of being used in conjunction with the Janus clinical data warehouse.

Waban SCE was selected for a multitude of reasons, not the least of which is ensuring compliance with 21 CFR Part 11. “Waban offers a completely controlled environment where everything done to data is audit-trailed, including when information gets handed off from clinical data management to biostatistics and from biostatisticians to medical writers,” says Soloff. Since Janus also has an audit trail, “we’re completely confident that we can show a watertight chain of data custody and provide comprehensive documentation proving data integrity.”

From Waban Software, Genzyme gets assistance on an assortment of quality assurance functions, notably tracking progress on validation, quality control, and data delivery activities, says Soloff. SCE accomplishes change control by tracking “run dependencies” to ensure information is “never stale, meaning that any updates made to data or programs during clinical development are cascaded and reflected in final, FDA-bound reports.” Other Waban tools will allow the company to more effectively manage versioning and change management for standard software modules, thus “promoting their development and use.”

The rich metadata gathered in the process will “help with efficiency gains in a number of ways,” says Soloff. The “automatic handoffs” from programming to testing, review, and delivery “reduces e-mail and communication overhead as well as time delays. The metadata can also be mined to develop reliable metrics regarding time and resources needed for each step in producing a particular deliverable. That, in turn, will allow Genzyme to better budget human resources in the future as well as identify bottlenecks.”

The management dashboards are currently being implemented at Genzyme and will provide “transparency into whether a project is on track” so resources can be adjusted intelligently.

Importantly, Waban SCE has metadata-driven “smart architecture” that allows Genzyme to independently “enhance the functionality of just about anything,” says Soloff. “With SAS Drug Development, it would be far more difficult for us to extend the functionality without bringing in SAS consultants.”

The Waban Advantage
Companies want a more efficient process for data analysis and reporting as well as a means to automatically trace how, when, and by whom critical reports were created, says Pratap Malik, PhD, Waban’s vice president of strategy and business development. They especially want help managing large clinical research projects that involve potentially hundreds of biostatisticians and statistical programmers working collaboratively to scrutinize data using SAS, Insightful Corp.’s S-Plus, other data analysis programs, and perhaps data visualization tools like Spotfire or even Excel. “Today, [data analysis and reporting processes are] mostly managed in a paper-based system and there is no controlled way to do that.”

Given current drug safety concerns, Malik continues, companies themselves are trying to be more responsible by rapidly responding to any disturbing signals in the data. Growing interest in adaptive clinical trials also has them seeking out a means to quickly tease patterns out of large volumes of incoming data.

For all functional areas within drug discovery and development, Waban Software views data analysis and the reporting of data as a “continuum,” says Malik. Waban Clinical Data Repository (CDR) houses all clinical trial data, associated documents, analysis programs, reports, and related information about how a trial was conducted in “one controlled place.”

Perhaps more importantly, Waban CDR (like Waban SCE) allows knowledge to be retained within an organization, says Malik. “Companies employ sophisticated analysts and programmers, and how they produce an analysis is most often information kept by that scientist…so when those people leave, the information is lost. The data is there to replicate [the analysis], but [companies] have to rework through the whole analysis process, as the connection between the data and reports is lost.”

Clinical data warehouses are also being promoted by SAS and Oracle, which is building a life sciences hub. “We’ve advanced our product faster than any of our competitors,” says Malik. “Architecturally, we have a product that works with multiple systems and vendors for analysis and reporting. Companies can work with their favorite platforms and analytical tools.”

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