Perceptive Informatics, an eClinical solutions provider and technology subsidiary of Parexel International, and Fujitsu Systems West, a regional systems engineering company of Fujitsu, have announced a technology partnership to improve clinical trial data management in Japan.
The companies have integrated Perceptive's ClinPhone RTSM (randomization and trial supply management) solution and Fujitsu's DDworks 21 CTMS (clinical trial management system). The new offering automatically transfers data from ClinPhone RTSM into DDworks 21. In addition to eliminating manual data entry, it makes study logistical information immediately available for proactive decision making.
"Clinical trial management is often hindered by complex, time-consuming, manual processes for collecting, aggregating and rationalizing data," said Graham Bunn, vice president of partnerships, Perceptive Informatics. "Integrating our industry-leading technologies will replace fragmented methods for capturing and leveraging data. By streamlining these processes, clients can conduct clinical trials more efficiently."
Built on the Perceptive MyTrials platform and combined with Parexel's clinical experience, ClinPhone RTSM utilizes validated randomization methods, automated inventory control, dispensing and titration management, emergency code break capabilities and real-time supply reporting. It also provides sophisticated reporting to monitor trial management performance, analyze trending and forecasting information and deliver in-depth data analysis. Global clinical trials can be supported in multiple languages through the solution's secure access, detailed audit trails, transaction logging and compliance with U.S. FDA 21 CFR Part 11 and Japan MHLW ER/ES.
DDworks 21, Fujitsu's GCP risk management solution, is a software offering for clinical trial quality and regulatory compliance in Japan. Incorporating PMDA regulations and J-GCP guidelines, best industry practices and quality processes, it has been implemented by more than 80 pharmaceutical companies since 1996.