Clinical Trial Podcast

JULY 18, 2020

Sites are responsible for site-specific informed consent development, Ethics Committee (EC)/ Investigational Review Board (IRB) submissions, staff training including participation in investigator/ site coordinator meetings and site initiation visits and execute a clinical trial contract. Clinical Evaluation Committee (CEC).

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

The Pharma Data

AUGUST 16, 2020

After years of dedicated effort and collaboration, the FDA approval of ENSPRYNG exemplifies how patients, industry, and academia can find solutions together.”. The primary endpoint of both SAkuraStar and SAkuraSky was time to first protocol-defined relapse (PDR) adjudicated by an independent review committee in the double-blind period.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

Advarra

JUNE 16, 2022

Securing oversight committee approvals (IRB, IBC, SRC, RSC, COI, feasibility) . Do you need a data monitoring committee? . Do you need endpoint adjudication? . Institutional review board (IRB)/ethics committee (EC) submissions . They are responsible for but not limited to: . Consider the following: .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52