Tal Zucker, CEO
Clinical trials are essential for determining a new drug or device’s efficacy before its entry to the market. To maintain the high quality and reliability of data required for such trials, biotech companies today are on the lookout for effective clinical data management services. In addition to quality, all sponsors share the aim of reducing studies’ duration and accelerating the product’s entry to the market, all the while cutting costs. TechnoSTAT, a leading service-provider for clinical trials based in Israel, has answered the call to meet these demands with its new CleanDATA system. “CleanDATA is a platform to manage clean, accurate data while keeping the budget low, hence serving as an alternative to expensive data management systems,” says Tal Zucker, TechnoSTAT’s CEO.
Biotech companies often use burdensome Excel spreadsheets to capture data in early-stage studies. TechnoSTAT’s CleanDATA simplifies management of clinical paper-based studies. Not only is CleanDATA regulatory-compliant, CleanDATA also enables faster data cleaning during the study as well as allowing for oversight of the study progression. “Our simple and user-friendly CleanDATA solution helps customers manage their vast amount of data accurately. We provide our customers with an in-depth insight of their database, keeping them completely involved in the clinical process to identify and address issues early on,” outlines Tal.
In TechnoSTAT’s effort to address the industry’s need, a collaboration with the software development company B-DATA led the birth of the new data capturing platform. Having a known reputation for developing cloud-based EDI (electronic data interchange) solutions that comply with HIPAA (Health Insurance Portability and Accountability Act) and HL7 (Health Level Seven) standards, B-DATA was naturally selected to develop CleanDATA. The system is setup to allow the integration with any medical device, back office, legacy system or any external entity using standard or proprietary integration methods.
CleanDATA is a platform to manage clean, accurate data while keeping the budget low, hence serving as an alternative to expensive data management systems
Being a cloud-based application, the system can be accessible from any mobile or non-mobile device. This innovative approach for paper studies eliminates the need to address data reconciliation issues in the traditional printed manner and as a result improves study timelines dramatically. Its sophisticated role-based authentication process ensures that only the qualified, authorized person can carry out any given transaction. The system was designed to comply with the highest cyber security standards as well as regulatory requirements from day one, having each transaction logged in an audit trail.
Initially designed for addressing the data management needs of paper studies, CleanDATA includes built-in functionality to support double data entry and flexible user-friendly design tools for applying tailor-made solutions. Moreover, the system is set up for reuse of existing programming to shorten start-up time of subsequent studies.
Since its establishment in 1993, TechnoSTAT continues to extend its track record of success that includes dozens of regulatory approvals at the EMA and FDA. “As data management is turning to be the growth engine of our firm, we are planning to expand our CleanDATA development and services locally and internationally. “Our mission is to further develop CleanDATA into an EDC platform as well as constructing advanced modules to allow companies running small studies to enjoy our services tailored to their budget,” concludes Tal.