In addition to being an efficient solution for your data management and workflow support needs Promasys provides a quality system that supports your organization to protect the integrity of the clinical data and to comply with international regulations.

Through the implementation of the Study Life Cycle, Promasys superimposes a quality system on its data management and workflow functionality, that supports your organization to comply with GCP and other relevant regulations. However, Promasys does this in a way that follows the natural order of a clinical trial and therefore minimally interferes with an efficient conduct of the trial.

Access rights can be configured to reflect the role and responsibility of a user in the organization. In combination with the phase of the Study Life Cycle, the functional role of the user defines what he or she can do at a certain moment in the application. For instance, when the trial is still in the Study Definition phase, you would want a project manager or investigator to be able to create new design itmes or make changes to exising items. But when the trial is in the Execution phase after regulatory and ethics committee approval, you wouldn't want these same persons to make changes to the design. Instead, you would want to allocate the right to make changes in the design to a special functional role. This can be the QA manager, or any other person that you want to have this responsibility. In order to make the necessary changes to the design, this person could set back the trial to the Study Definition phase, make the necessary changes, and then bring back the trial to the Execution phase again. This situation typically occurs when there is a protocol amendment after the start of the clinical phase of a trial. Promasys offers the platform to make such design changes in a quality controlled way. And all changes are being tracked in the audit trail.

Promasys  further helps you to produce high quality clinical trial data  by allowing you on the level of  the study design to specify pre-formated data types, including code lists, and defining upper and lower limits for the trial data. You can also specify normal values e.g. for lab results, and later run a report on your data that provides you with all the outliers. During data entry, the data type formats and the defined upper and lower limits do their work to help prevent entry of erroneous data. Blind dual entry is another available tool to further guard and improve the data quality, together with for instance the query management function.

Once the trial is in the Execution phase, and trial data are entered into the databse, Promasys tracks all creations, updates (changes) and deletes of individual data, and automatically adds a date and time stamp and a user ID to identify the person who made the entry.  In this way, Promasys provides maximum protection of the integrity of the trial data. And thus helps your organization to be compliant with GCP and international standards.

Audit trail for individual data item