Clinical Trials & Surveys Corp. will provide Johns Hopkins University with its StudyCTMS clinical trials management software and data quality services for less than $50,000. That's "significantly less than it would cost to hire a CRO to complete the same work," according to an announcement.
Hopkins will implement the electronic data capture module of StudyCTMS to collect trial data using online forms. The effort is for the Phase 1 trial of a vaccine candidate. The online capabilities will replace a paper-driven process.
StudyCTMS is a proprietary data management application suite that enables investigators to develop and manage clinical studies and deliver the accumulated data and metadata in FDA-acceptable format. The solution is designed to aid private, small- and medium-sized researcher organizations in conducting human clinical trials and produce results in an FDA-acceptable format.
Last April the company began offering consulting services for the conversion of clinical data into the new standard Study Data Tabulation Model (SDTM IG 3.1.2) format for submission to the FDA. It had worked with the FDA in developing procedures for the receipt, processing, and analysis of clinical trial data submitted for regulatory approval. All clinical data must now be submitted to the FDA in SDTM format, a platform created by the Clinical Data Interchange Standards Consortium (CDISC), which creates standards for the use of clinical research data.
- read the Johns Hopkins University announcement