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Genzyme: Biostatistics with Waban SCE

A few posts ago you heard me rant about the inexplicable secrecy that tends to surround large biopharma IT projects. So, it's with great pleasure that I can report that not all biopharma companies wish to keep everything to themselves.

Specifically, I want to draw your attention to a recent article in eCliniqua and Bio-IT World related to Genzyme's implementation and use of the Waban Statistical Computing Environment (SCE.)

As you will learn from the article, “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 Dana Soloff (Genzyme’s director of statistical programming.)

Note: In the interest of full disclosure, I have a continuing business relationship with Waban Software and also helped implement the SCE platform at Genzyme.

SCE can be thought of as a process and audit control layer that sits on top of already existing systems used to manage, analyze and report on clinical data. In the simplest of terms, SCE will allow statistical programmers and biostatisticians to do their work with familiar tools (e.g. SAS, SPLUS, Spotfire) while adding collaboration, data sharing, metrics reporting and data integrity features. One of the strongest capabilities of the platform is the automatic linking of datasets, programs, macros and output reports to each other. For example, the system remembers that version 3 of a dataset was analyzed last Wednesday by versions 5 of program X last modified by programmer Jones on October 6th and resulted in the generation of version 2 of report Z which was sent to medical writer Smith on November 18th.

Quoting Soloff, the article states that 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.”

On the collaboration front, the “automatic handoffs” from programming to testing, review, and delivery “reduces e-mail and communication overhead as well as time delays."

From the project management perspective, 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.

The Waban SCE product is one component of a larger data management suite sold and supported by Waban Software. These include:

  • Waban CDR (Clinical Data Repository)
  • Waban LIMS (Laboratory Information Management System)
  • Waban SMS (Specimen Management System)
  • Waban Explorer (Data exploration tool)
  • Waban DSS (Drug Safety System)

Further information about these products can be found on the Waban web site.

As always, whenever a job is important enough to be done, there are several companies that try to help. This is no different in the SCE/CDR space where three other software products need to be considered:

Comments

Project Management Software

Traditionally, project management includes a number of elements: four to five process groups, and a control system. Regardless of the methodology or terminology used, the same basic project management processes will be used.

Giri

Hi,
I would like to add another product iDERT which is a competitor to SAS SDD, Oracle Life Science Data Hub, SCE. iDERT has already been running at Ranbaxy Laboratories, which is the largest Pharmaceutical company in India. iDERT offers integrated system that performs Data Extraction from various sources, provides mockup creation, generation of Analysis DSs, Generation of TLFs, Appendices portion of CSR, Clinical Data Standards (SDTM/ADaM) Conversion and eCTD M5. iDERT offers a fullfleged process automation for the CROs and Pharmaceutical who have to manage more than 20 studies a year and complete the analysis and submission in less than a month.

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