Pharma companies are looking for any opportunity to reduce the clinical trials stage of development so they can get their products on the shelves and begin recouping those costs.
Typically, doctors participating in clinical trials collect data manually using paper Case Report Forms. 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.
Digital Pen and Paper technology also fits in well with human 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, a change of dosage, a diagnosis or a professional practice requires involvement by the patient as well as the doctor. Digital Pen and Paper technology is is perfectly suitable. It not only optimises data collection because it is an intuitive and universal tool, but also optimises data quality. The time-stamp features allow an exact analysis of the date (and time) when the patient completed the questionnaire.
Clin’Form offers our clients the ideal global solution for capturing clinical trial data: providing the easiest data collection method possible for both patients and physicians (pen and paper) combined with all the advantages of electronic data management (accurate timestamps, audit trail functionalities, real-time access, alerts, etc.). This unique paper-based e-trial solution allows customers to use a single, integrated platform for collecting both CRF and patient diary data, significantly streamlining clinical trial costs.
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