Since April 1st 2011, Frank Arnold MSc. joined Promasys, to establish our own dedicated customer support center in Tokyo. Although the primary focus is on supporting existing customers in Japan, the center will also provide support and training for customers in other countries in East Asia, in close collaboration with local agents. In addition, Frank will collaborate with Promasys' commercial agent in Japan, Yoshihiro Kumekawa, to further broaden Promasys' customer base in Japan.

Frank obtained his Master’s in Biomedical Sciences in 2003, at the University of Leiden, the Netherlands. After working as a Clinical Scientist at the Centre of Human Drug Research (CHDR) in Leiden for one year, he joined the Tokyo Research Center of Clinical Pharmacology (TRCP) in Tokyo, Japan in 2004, where he was responsible for clinical research coordination and data management tasks of sponsored clinical trials.  In 2007, he left TRCP for Showa University Hospital’s Clinical Trial Support Center (CTSC), where he was responsible for the promotion of on-site data management. From April, 2011, Frank joined Promasys BV to strenghten the company’s customer support in East Asia.

Frank is currently also involved in research at the school of Pharmaceutical Regulatory Sciences of the University of Tokyo, where he investigates international differences in approved drug doses.

The World Health Organization is using Promasys software for clinical data management in a randomized controlled pivotal trial in 2000 infants in India, with the objective to evaluate the immunogenicity and safety  of a measles vaccine given by aerosolized inhalation.

The first subject was enrolled in December 2009 and subsequent recruitment went smoothly. Presently, the clinical phase has been completed successfully.  Data management is performed by a dedicated team at Christian Medical College in Vellore, Tamil Nadu. The team was trained and supported by Promasys and its local distribution partner Kingslake.
WHO staff confirmed that the use of Promasys software and the provided training and support which included mentoring in the early stages of data management greatly helped the team in Vellore to perform their data entry and data management tasks efficiently and to ensure data quality and compliance with GCP.

We are proud to announce the official release of version 6.1 of our Promasys Clinical Trial Data Management and Workflow Support software.x

Version 6.1 brings important new features to our users: the WebCRF and electronic signatures.

The WebCRF

The WebCRF is Promasys' own EDC system. It is an additional module to the Promasys core application. It provides access to the Promasys database for data entry and data management tasks through a standard web browser. On the client side, no software installation is required. This makes the WebCRF an ideal platform for multi-center studies.

Users with suitable access rights are able to enroll new subjects and perform data entry tasks. The wealth of data entry support functions of the main interface are also available in the WebCRF: data types, code lists, units, input formats, confirmation and refusal limits, etc. Data managers can view the data -including notes and the history of the individual data items (from the audit trail)- and issue queries and perform query management tasks.

Similar to the paper CRFs and the data entry screens in the native interface, the screens of the WebCRF are automatically generated from the clinical study database design. So there is never a discrepancy between the data collection screens and the database. Changes in the design, e.g. resulting from a protocol amendment, are automatically and consistently implemented in all screens and forms. Access to the system is controlled by robust business logic at the server level. Your data remains fully protected, whether you work in the native interface or through the WebCRF.

While the native Promasys interface is available only in English, the interface of the WebCRF can easily be made available in local languages.

Electronic Signatures

The new Electronic Signatures functionality of Promasys allows authorized users to sign off data for review (e.g. by the data manager) and for approval (e.g. by the Principal Investigator). Data can be signed individually or in batch mode (e.g. per subject visit). The responsibility to sign for AE’s and Conmeds can be assigned separately (e.g. to a physician). While Electronic Signatures are particularly relevant for EDC based trials, Promasys will continue to fully support paper CRF based trials, and in fact is ideal for managing hybrid trials, as during the design phase of the trial it can be indicated for each individual variable whether or not dual entry is required (typically required for paper CRF data) and whether or not electronic signatures for review and/or approval are required. This allows for maximum flexibility, and at the same time enables our users to fully comply with the strictest rules and requirements

The Electronic Signatures functionality of Promasys version 6.1 is fully compliant with 21 CFR part 11.