BA/BE CTMS Solution - Clinical Trial Management for BIO Availability and BIO Equivalence Studies
HCL AXON’s Clinical Trial Management solution for BIO Availability and BIO Equivalence (BA/BE CTMS Solution) addresses key white spaces in Oracle’s Clinical Trial Management Solution (CTMS). Our solution is for Life Science organizations managing drug studies related to Bio Availability and Bio Equivalence. Clinical trial management studies of this nature do not pass through phases and are mostly conducted within the clinical research organizations where research has often been outsourced. HCL AXON has developed a solution using Oracle CTMS to enable proper management of these studies.
Our BA/BE CTMS Solution allows drug manufacturers and various clinical research organizations to securely track BA/BE clinical trials’ study progress in a systematic manner. It provides first hand information about status at any given point in time, and also provides consolidated reports for every stage of each study from feasibility or confirmation to final report dispatch, meeting regulatory standards including 21 CFR Part II.
HCL AXON’s BA/BE CTMS Solution has the following features:
- Captures clinical analytics and clinical flow
- Captures specific information about various approvals required - like clinical trail approval, import license approval, GEAC
- approval, DGFT approval and any other approval before carrying out the trial
- Captures infrastructure information.
- Automates the booking process of machinery and beds allocation in a BA/BE Study.
BA/BE Solution Flow
- BA/BE Clinical Flow
- BA/BE Analytical Flow
- Booking of Beds
- Preponement/Postponment of Beds
- Cancellation of Beds
- Machinery Booking.
Industry Page: Life Sciences Group