When performing data collection as part of a clinical trial, Life Sciences and Biotechnology companies are under constant pressure to accelerate data capture processes while complying with Federal Drug Administration (FDA) regulations known as "21 CFR Part 11". Although this compliance requirement allows the use of electronic forms and electronic signatures for greater efficiency, it stipulates that many additional controls must exist to maximize data accuracy and tracability. Often times, these controls are difficult to incorporate and validate with custom off-the-shelf software and traditional electronic form formats such as PDF and HTML. By utilizing best-of-breed, component solutions that have been vendor-validated against the "21 CFR Part 11" specification and provide a detailed third-party compliance statement, Optiform is able to provide Manufacturers, Sponsors, Partners, Investigators, and Clinical Research Organizations with compliant and affordable data collection technologies.
- Tablet PC based CRFs
- Web-based CRFs
- Fax-based CRFs
- Paper-based CRFs
- Consent Forms
- Lab Result Reports