Ethical review support for clinical research
We navigate the IRB process with clarity and efficiency. We know how to effectively draft an application for clinical trials, post-market studies, or early-phase device evaluations. We prepare and manage IRB submissions to meet both regulatory and ethical expectations.
Institutional Review Board (IRB)
Why IRB Matters
An IRB safeguards participant rights and ensures your study meets legal and ethical standards. It’s a critical step in regulatory approval and credibility, especially for clinical trials and studies intended for publication.
Before any research involving living subjects can begin, it must undergo review by an IRB to ensure:
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Participant rights and safety are protected
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Protocols are ethical and scientifically sound
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Risk is minimized and justified by potential benefit
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Regulatory compliance is maintained (ICH-GCP, SFDA and MoH Guidelines)
For sponsors, IRB approval is essential for:
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Building clinical credibility
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Avoid legal risk and regulatory delays
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Improving practitioner trust in the evidence behind your product
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Strengthen the credibility of the study, making it more likely to be accepted in publications, submissions, and marketing claims
What We Do
IRB Application Preparation
We prepare all required documents for IRB submission, including clinical protocols, informed consent forms, investigator CVs, study synopses, and supporting documentation. Our team makes sure that everything is presented clearly, ethically, and in line with local and international standards.
Submission Management
We oversee the entire submission process, whether through a local hospital IRB, academic institution, or an independent ethics committee. We handle correspondence, track timelines, and respond to requests or queries to keep your study moving without delays.
Multisite Study Coordination
For multi-center trials, we manage the submission process for each site. We standardize documentation and coordinate approvals to maintain consistency across all centers.
Ethics-Ready Protocol Design
We work with you during the study design phase to flag ethical issues early. We help you build protocols that meet the study objectives, respect participant safety, minimize risk, and meet ethical standards from the start.
How We Work
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Risk & Gap Analysis
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Protocol and Document Development
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IRB Strategy and Submission Planning
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Your Study Begins
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Approval and Continued Oversight
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