Clin'Form suite : clinical data collection
An electronic data capture clinical trials
Clin’Form offers our clients the ideal global solution for capturing clinical trial data: providing the easiest data collection method possible for both Sponsors, Investigators, CRAs, Patients and more.
Kayentis offers “the unique paper-based e-trial solution” named Clin’form®. It is dedicated to the clinical trials industry, combines the best that the physical and the digital world have to offer: the easiest data collection method for both patients and physicians (pen & paper), offering the highest quality of data, combined with all the advantages of electronic data management (accurate timestamps, audit trail functionalities, real-time access, alerts, etc.); while significantly streamlining clinical trial costs.
Medical practitioners participating in clinical trials collect data manually using paper in Case Report Forms. Under some methods, at least two people type the manually-collected data into various databases to ensure accuracy through dual data entry.
To combat these issues, companies have adopted electronic data capture (EDC) solutions to speed the time between data collection and availability. But though there has been rapid adoption, many physicians find this EDC implementation unnatural to their preferred way of evaluating patients.
Some sponsors also have doubts regarding the quality of the data collected with EDC (studies have shown that there is often a week period between the data collected and the data entered in the CRF- sometimes by another person and not the doctor).
Digital Pen and Paper technology
Digital Pen and Paper technology fits in well by preserving face to face interaction (there is no computer screen interfering in the doctor–patient relationship) and preserves medical confidentiality.
In addition, an increasing number of studies are based on Patient-Reported Outcomes (PRO). To evaluate the effects of a drug, or a change of dosage, a diagnosis or professional practice requires involvement by the patient as well as the doctor.
Digital Pen and Paper technology is perfectly suitable. It not only optimizes data collection because it is an intuitive and universal tool, but it also optimizes data quality.
The time-stamp features allow an exact analysis of the date (and time) when the patient completes the questionnaire.
Clin'Form : specific features to the pharmaceutical industry
• Quick and easy deployment of multi-centre studies.
Clin’Form, e-clinical trials features and study impacts
• Clin’Form product ready to use immediately: studies can be ready to start in a just a few weeks; 2 to 3 weeks for a short study