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Promasys: Empower the Researcher |
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As more and more requirements are put forward by regulatory authorities, the importance of carrying out clinical research with stringent quality control in drug development is increasing. Research organizations are responsible for data quality and integrity, and for compliance with regulatory requirements. It is essential that the researcher is in control of the design; setting up and conducting clinical trials should be as efficient as possible, especially since Clinical Research Organizations (CROs) have resource limitations. Promasys, an advanced clinical trials software, was developed in 1988 by Prof. Adam Cohen and Jos Hennen from Leiden, Netherlands, to facilitate regulatory compliance and analysis. Validated in over 300 studies, Promasys is a software used extensively around the world by clinical researchers today. Over 250 publications based on studies managed with Promasys have found their way to international scientific journals. |
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For Promasys, quality means protecting data integrity, enhancing data quality and being compliant with regulations Promasys supports organizations to comply with GCP and regulatory requirements, inclusive of CFR 21 Part 11 by providing the following features: Extensive Access Control Tracking and protecting the integrity of data Dual data entry Audit trail for changes to data and study design Screening results validation against in- and exclusion criteria Standard Operating Procedure (SOP) management functionality to link SOPs to study activities
Multi Language Support
Promasys 5.0 supports double byte character languages including Chinese, Japanese and Korean. This facilitates Case Record Form (CRF) development in the local language. Bilingual CRFs may also be easily developed. Consistent User Interface
The basic layout of the interface is consistent throughout the various modules of Promasys, resulting in a shorter learning period. Users learn how to use all modules and functions quickly. Screen colors may be configured to fit the user’s taste, and can also be set to change depending on the active module. Extensive On-line Help
Promasys has extensive context-sensitive online help functionality; online tutorials are available to enable users learn how to use the system quickly.
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Bringing the CRF to the Web |
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In partnership with Kingslake, Promasys is currently finalizing exciting new functionality, the WebCRF, which will enable trial data entry with a standard web browser. The WebCRF will offer enlistment of subjects into the study, generated data entry screens matching trial design, dual entry mode and query management functionality. Users can easily manage trials running at different sites around the world without having to install software or worrying about access through firewalls. As always, this functionality comes without any programming; it is fully integrated into the access control and audit trail mechanisms in Promasys.The WebCRF is scheduled for release in the near future. |
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