Clinical Data Repository (CDR) Vendors

Since Clinical Data Repository (CDR) software is a relatively new software category, there are only a few vendors with any type of track record. Of the three companies listed, Waban Software has the most mature and stable offering. SAS Drug Development was originally the product of a SAS Institute-backed startup called iBiomatics. This company is no longer in business but the software was pulled into the SAS Healthcare and Life Sciences organization. Entemo's product is the newest on the scene and was developed with input from Bayer.

Because our industry tends to be quite secretive, I do not have a complete picture of the installed base for these products. The best I can do is to suggest that before you make a product selection, insist that the software firm provide you with a complete list of their clients. Then, make sure you talk to at least two or three separate companies about their implementation experience and satisfaction with the software.

Vendor	Product	Description
Waban Software	Waban Explorer-CDR	Waban Explorer-CDR allows clinical researchers and bio-statisticians to explore, browse and query clinical data and create analysis datasets as needed. Waban Explorer-CDR provides integrated analysis, drill down, visualization and web based reporting of clinical trial data, addressing the specific need of clinical researchers and bio-statisticians. Key features include: Multi-dimensional data browser with flexible drilldown Ad-hoc query builder, with drag and drop query development Pivot/and fold data Link analyses and reports to data to maintain traceability Waban Explore-CDR is designed to integrate with leading clinical data management and regulatory data management systems. Customers can also integrate proprietary and custom clinical databases with Waban Explorer-CDR. End to end traceability of the data is ensured by automating and auditing the data extraction from the source systems and tracking the loading of the data. Waban Explorer-CDR for clinical data review is built on Waban Software’s proprietary Life-Sciences Information Management platform and is based on clinical data warehousing technology. The load and extract process is automated and logs and audits are maintained in the database which can be readily browsed. .
Waban Software	Waban SCE	Waban SCE (Statistical Computing Environment) provides a controlled and integrated 21 CFR Part 11 compliant statistical computing environment to formalize and automate the clinical biostatistics processes. Waban SCE features include: Integrated statistical programming environment Version controlled check-in and check-out of datasets, documents and scripts Workflow Generation of tables, listings and graphs Traceability Web-based reporting Templates to formalize study definitions Integration with leading analysis tools including SAS®, S-PLUS®, Spotfire® etc. All objects are versioned and the job control component ensures that standard reports such as the creation of a binder can be automated and tracked. Further, complete traceability from the source datasets through the analysis programs to the output is maintained by managing inputs and outputs. The system supports the direct publication of reports from the statistical computing environment to the document management systems for submission by regulatory affairs.
SAS Institute	SAS Drug Development	SAS Drug Development provides a centralized, integrated system for managing, analyzing, reporting and reviewing clinical research information. The solution enables life sciences organizations to make informed business decisions with confidence, to assess the safety and efficacy of research compounds more effectively, to collaborate across trials, phases and therapeutic areas successfully, and ultimately get better products to market faster. SAS Drug Development enables significant efficiency and productivity improvements within your R&D organizations, which translate into decreased development costs, a faster time-to-market and improved earnings. Drawing on the power of the SAS®9 Intelligence Platform, SAS Drug Development specifically addresses the compliance requirements of life sciences organizations, while supporting your business objectives and aims to: Integrate molecular information with clinical outcomes. Deliver better therapies to market more quickly. Control costs. Comply with increasing regulatory requirements. Collaborate globally. Build a centralized, searchable repository of all research information. Assess safety and efficacy more effectively. Meet shareholder expectations. Optimize efficiency and productivity across the life sciences value chain.
entimo	entimICE DARE	entimICE DARE is a controlled and fully integrated solution that ensures seamless operation across different stages of clinical development and provides a unified, reusable and compliant production environment for integrating, managing and analyzing clinical information and producing regulatory reports. entimICE DARE brings together disparate information sources both within and external to the research and development organization, along with providing the value-added tools to manage this information, thereby streamlining clinical study opera-tions, reducing costs and time-to-market, and helping research organizations identify new revenue opportunities and bring better products to market faster. In addition, entimICE DARE directly addresses the complex regulatory requirements mandated for organizations that are involved with electronic information related to life sciences research. At the heart of the solution is a so-called repository, which provides the means to build and centrally maintain study information (data, programs, reports, documents, images, etc.) together with the server based applications (metadata management, data import and transformation as well as analysis and reporting tools) necessary to take full advantage of the repository.

Comments

[Dave Handelsman]

While many of our SAS Drug Development customers prefer to remain confidential, there are a number of public references available regarding SAS Drug Development and Clinical Data Repositories. More information can be found at:

http://www.sas.com/success/daiichi.html

http://www.sas.com/success/solvaypharma.html

http://www.sas.com/success/neopharm.html

These are just a small public sample of the dozens of successful SAS Drug Development implementations in the life sciences marketplace.