Compliant and standards based eClinical research solutions.
MedNet's eClinical research solutions have been used around the world in support of product approvals, label/indication changes, and claims support. Our technology is fully compliant with both 21 CFR 11 and HIPAA requirements, and has robust audit and report capabilities well beyond the minimum required to ensure your important research stays on track.
MedNet also conforms to other, non-governmental industry standards to fully address customer needs. MedNet complies with GCP guidelines, and has long been committed to utilizing the standards approved by the Clinical Data Interchange Standards Consortium (CDISC). As an example, MedNet’s ENLIGHTEN solution has been certified by CDISC as complying with the Operational Data Model (ODM) standard. In addition, iMedNet has been built from the ground up with all CDISC standards in mind and even includes a library of C-Dash compliant case report forms.
MedNet employs numerous, highly-skilled personnel, including clinicians and former sponsor and CRO staff, whose critical insight and advice on regulatory strategy and study design/implementation add significant value to your eClinical research initiatives - because technical skills alone aren't enough.
