Bioequivalence and Bioavailability Forum

Hi Constantinos!

❝ Who should be the person responsible for performing the randomization and blinding during a BE? I guess not someone directly involved in the clinical or analytical part of the study.

Ideally the sponsor.

❝ Could this person be the Principal Investigator?

Yes – although I would not call the PI “not […] directly involved in the clinical […] part of the study”.
Regardless BE studies generally are open label, some regulators prefer the AE-monitoring performed blinded for treatment. If you don’t have ‘spare’ sub-investigators this requirement is difficult to fulfill.

In the CRO I was with we had a system where the PI wrote the protocol based on macro-assisted templates; the randomization, printing of tear-off labels of the IPs, bar-coded sample labels, and mapping of the entire study in a LIMS was performed in the background. Was quite a job to validate this stuff and pass GLP-certification and GMP/GCP-inspections. Wouldn’t recommend it to anybody lacking a lot of stamina.