Bio-availability and Bio-equivalence (BA/BE) studies are characterized by the duration, subjects/volunteers involved, types of visits, administration of the investigational products and the pace of procedures conducted during the study. Standard IRT/IWRS and EDC products used for clinical end-point studies cannot handle the BA/BE studies.
SyMetric BIO is a cloud based web platform exclusively built to handle Bio-availability and Bio-equivalence (BA/BE) studies. The specialized features of this product can easily handle short duration, open label, multi-arm, cross over studies over any number of periods. In addition; the full-fledged project management features of CTMS, data management features of EDC, Medical Coding, and Pharmacovigilance functionalities are bundled into this platform.
SyMetric BIO is completely 21 CRF Part 11 and ICH - GCP compliant. It is designed exclusively to drive the business processes which are specific to BA/BE studies such as check in and check out, ambulatory visits, monitoring washout periods etc. With a wide range of inbuilt data management functionalities such as Discrepancy handling, Source Data Verification, CDISC/SDTM data exports, medical coding, AE/SAE reporting, bookmarks it eliminates the need for having multiple systems to perform each function.
Perform fool proof volunteer registrations using Biometric-aided enrollments
Parallel or Crossover based Treatment assignment to Subjects
Effectively manage and integrate lab data into the eCRF to improve lab efficiency
Capture clinical data of Subjects into streamlined and simplified eCRFs