Informed consent form: clinical data management by Kayentis

Informed consent forms are essential documents to be completed by patients taking part in clinical trial studies demonstrating the patients understanding of the facts, implications and risks involved and voluntary agreement to participate in the clinical trial study.

Electronic informed consent forms are part of the paper and pen technology developed by Kayentis for the clinical trials industry.  

The Clin'form platform provide quick and easy data collection in the form of digital pen and paper used by both physicans and patients to complete the necessary documents through clinical trial procedures. The paper-based e-data capture platform provides electronic informed consent forms, patient diaries, electronic diary system, Case Report Forms; SAEs for accurate data capture and transferred to a web portal in real time.

Kayentis has combined handwritten data collection with electronic data capture allowing both personnel and patients to use the most common and secure method of data entry: the completion of handwritten forms on intelligent paper with real time electronic data capture by the digital pen's camera. Clinical data, such as informed consent forms are transferred to a web portal, developed with data management capabilities such as traceability, timestamping, monitoring capabilities... Kayentis has developed the Clin'form platform to optimize data capture and management of clinical trial data with savings in time and data processing costs.

Informed consent form with a digital pen and paper

The Clin'form Digital Pen and Paper has been designed using Forms Automation Systems (FAS)and is a solution for collecting handwritten data that can be shared and processed in a high information sharing environment such as medical care and research.

 Please, feel free to contact us for more information about informed consent form.