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Our experience with global regulatory authorities safeguards timelines, maintains compliance, and mitigates risks so you can focus on driving research forward.
With Boca Bio, you can trust your clinical sites remain compliant and data is audit-ready.
We thoroughly vet and closely monitor clinical sites so biospecimens are always collected ethically and comply with IRB, EC, or MOH-approved protocols.
We design and validate electronic case report forms (eCRFs), configure, and test the EDC systems to align with your unique study requirements.
Our team stays current with the latest regulatory guidelines to keep your filings, data, and clinical trials compliant.
We help your team efficiently organize, easily access and consistently update records to enhance transparency, improve audit readiness, and streamline filings.
We design and implement risk assessments, monitoring plans, and reporting to maintain project integrity and mitigate regulatory delays.
We develop, align, and coordinate site selection, staff training, and oversight to safeguard compliance throughout study duration, including biospecimen collection and data handling.
We maintain transparent and open communication to keep your team audit and submission-ready.
IRB documentation review and revision
IRB submission
IRB fee handling
Regulatory site file preparation
Site regulatory document verification
Compliance oversight
Compliance with ICH GCP guidelines
Trial Master File (TMF) maintenance
Reporting
Preparation of monitoring plan
Monitoring report draft and review
We partner with your scientists who are passionate about developing solutions that improve patients' lives. With Boca Bio, your team gets the necessary cancer specimens, services, and data to develop therapies, companion diagnostics, biologics, and novel cell and gene therapies. Let us support the development of your next precision oncology breakthrough.
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Yes, Boca Bio maintains compliance with all IRB approvals in place for our U.S. sites, as well as ethics committee/MOH approval for all international sites.
One of the advantages of using Boca Bio is that we have established IRB/ethics committee/MOH approvals in place for your projects. Some IRB/ethics committee/MOH approval processes can take weeks or months depending on the site and location. If a protocol approval is not in place, then an application will be submitted to the IRB/ethics committee/MOH.
