Dealing with authority notifications quickly and professionally
Many processes in Germany are strictly regulated and require a high degree of attention as a deviation from the norm might have undesirable consequences. The utmost compliance with regulations usually comes at a price, namely a lot of personnel and manual activities. Thus, for example, changes in the study design of clinical trials have to be reported to the respective authorities to document a correct implementation.
The required data often come from different sources (monitors, CTMS Clinical Trial Management System, etc.) and need to be checked for veracity before further processing takes place as not all systems are “source data verified”.
NOAH! may relieve responsible clerks from a large part of the work and actively support them by directly providing change notifications. The otherwise customary inquiry about potential study changes in other departments is obsolete as NOAH! recognises the important data from the CTMS via interfaces and reports them to the responsible case processing, e.g. in case deadlines need to be observed.
- NOAH! indicates, which authorities need to be notified.
- NOAH! distinguishes between “important” (immediate notifications) or “less important” notifications (to be considered in the upcoming routine notification).
- NOAH! supports the work of the authority.
- NOAH! shows the status of past notifications sent to the authorities, notifications due to be sent AND the actual status, including all current changes.
It is up to you to choose which of the received change notifications need to be considered in the new report.
If important data are missing for the final print, NOAH! points out each missing parameter. Only if all the necessary documents/data have been compiled, NOAH! generates the form-bound and mandatory paper version as PDF as well as the complete correspondence, including the necessary evidence.
The receiving authority is provided with a completed form and all changes that have occurred since the last notification are marked.
- NOAH! provides an overview
- NOAH! saves time and money
- NOAH! helps you with all reporting to the authorities
Any further questions? Please contact us!