CRO to launch FDA-friendly CTMS

Bob Kaplan plans to use his software-innovation experience to put some pre-commercial tweaks on StudyCTMS, the regulatory-informed clinical trial management system developed by contract researcher Clinical Trials & Surveys Corp. C-TASC says it will launch a commercial version of StudyCTMS later this year.

Kaplan, who was just signed as C-TASC CIO, says in an email interview that he wants to add features to the system to improve its trial management capabilities. The software-as-a-service platform already supports the Study Data Tabulation Model (SDTM) format of the Clinical Data Interchange Standards Consortium, as well as an image document management system. He is also planning for rotational graphics and an executive information system dashboard.

StudyCTMS has been used as an in-house working tool for the CRO and benefited in 2008 from a Small Business Innovation Research grant from NIH for further development. That same year saw the FDA's decision to implement the system in an effort to streamline its methods for accepting new product applications in the standard SDTM format. That work continues today.

C-TASC has seemingly sprung to life in the last few years, following two decades of best practices management work for clinical trials in government, academia and industry. The company now offers trial management consultation and continues its FDA work by aiding the effort to convert legacy data into the SDTM format. Commercial sales of StudyCTMS will open a new revenue stream for the company.

Kaplan is no newbie when it comes to health care and the life sciences: He has held executive IT positions at the Iowa Foundation for Medical Care, the National Committee for Quality Assurance, and WebMD. His new role encompasses both internal IT strategy and the further development of the CTMS software.

- see the announcement

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