e clinical trials : reduce Fraud and misconduct
Clin’Form®, the best asset to reduce risks of misconduct and fraud in clinical trials
Misconducts are not negligible in the clinical research area. Their consequences can be harmful: they can lead to the decrease of the powerful trial or to the MAA (Marketing Authorisation Application) withdrawal or refusal. It is in the sponsors interest to use all offered means to limit misconducts and improve the quality of data captured.
Kayentis Clin’Form® solution is the optimal paper-based e-data capture solution, allowing the management of clinical and therapeutic data focusing on the patient. Handwritten electronic data collection occurs thanks to the digital pen and smart paper. This data is then integrated into an information processing system which allows data sharing and processing via a dedicated web portal; and this without any break in the information processing chain.
This solution combines the best that the physical and the digital worlds have to offer. It is the easiest and most reliable data collection method for both patients and physicians, combined with all the advantages of electronic data management: these features highlight some misconduct cases and increase credibility of data captured:
Clin’Form® allows to define an indicator of data quality thanks to precise information resulting from time-stamping and audit-trail. The evaluation and consolidation of these indicators allow to calculate and maintain a global quality index for the centers.
All these tools have for objectives to make easier the checking tasks by making some controls before going to the sites. With Clin’Form®, sponsors have the means to better anticipate the misconduct cases and to optimize their clinical data quality.