IRB
IRB Overview
Our IRB operates as an independent ethics committee that ensures the rights, safety, and well-being of clinical trial participants. The board functions in full alignment with Good Clinical Practice (GCP) and ICH E6(R2) guidelines.
Includes:
- Medical Scientists (with clinical trial experience)
- Legal Expert
- Non-affiliated Community Representative
- Layperson For Public Interest
- Regular & Alternate Members Maintain Quorum Integrity
Standard Operating Procedures (SOPs)
- Developed Per GCP & ICH Standards
- Proposal Submission And Review Process
- Conflict of interest management
- SAE reporting and safety monitoring
- Protocol amendment reviews
- Continuing review and study closure
Turnaround Time
- Initial Review: within 7–10 working days
- Expedited Review: available for minor amendments
- Decision Communication: within 2 working days post-meeting
- Emergency reviews supported with 36-hour notice
Compliance & Quality
- Registered with relevant national regulatory bodies
- Full documentation, archiving, and audit-readiness
- Ensures ethical oversight of all studies conducted under AMZ CRO or provides outside supports as well.
DSMB
Data Safety Monitoring Board (DSMB)
AN independent DSMB provides ongoing oversight of clinical trial data to ensure participant safety and trial integrity. The board is activated for interventional studies, especially in high-risk or long-duration trials.
Expert Composition
- The DSMB includes experienced professionals with no conflicts of interest
Role in Trial Monitoring:
- Reviews interim safety data and efficacy trends
- Flags early safety signals and recommends modifications or termination
- Works in sync with PI, sponsor, and IRB for transparent oversight
- Provides formal written recommendations after each review
Regulatory Advisors
Regulatory Advisors
AMZ CRO’s regulatory team bridges international and local expertise with standard compliance, offering strategic guidance across the clinical development lifecycle.
- Rich network of Expert of regulatory consultants & scientists
- CTA/CT-NOC preparation
- Bioequivalence & pharmacovigilance submissions
- Protocol and dossier alignment with ICH-GCP
- IND/CTA package review
- Advisory support for Regulatory strategy development and global standard alignment
- End-to-end submission tracking and follow-up
Testimonials
What people say about us
“I greatly appreciate the communication on the very hard process, what we needed to do in terms of providing good samples, what to expect. Novalab laboratory provided tests what we needed in terms of laboratory certification that we can use with our customers.”
“I greatly appreciate the communication on the very hard process, what we needed to do in terms of providing good samples, what to expect. Novalab laboratory provided tests what we needed in terms of laboratory certification that we can use with our customers.”
“I greatly appreciate the communication on the very hard process, what we needed to do in terms of providing good samples, what to expect. Novalab laboratory provided tests what we needed in terms of laboratory certification that we can use with our customers.”
