GCP AUDITS SERVICES
BioBoston CRO provides Good Clinical Practice audit services for sponsors and clinical organizations that need an independent, risk-based assessment of trial conduct, investigator sites, vendors, systems, processes, data, or sponsor controls. Support can include audit planning, document review, interviews, remote or onsite assessment, evidence-based findings, reporting, and corrective-action follow-up.
Global Reach
Therapeutic Area Coverage
Years of Experience
START A CONVERSATION
Select the support you need and share a few details about your project. We’ll use this information to route your inquiry to the appropriate BioBoston team member.
Please do not submit confidential, patient-identifiable, or proprietary information through this form.
The engagement should be scoped around the current state of the work, the intended decision or milestone, the source package, and the sponsor's approval responsibilities.
Assess consent, eligibility, safety, protocol conduct, source records, data, investigational product, essential documents, delegation, training, and investigator oversight.
Evaluate the vendor quality system, capabilities, procedures, systems, records, controls, subcontractors, study execution, and prior findings against the intended service.
Focus the audit on critical processes, data flow, responsibilities, interfaces, compliance evidence, and material risk rather than using a generic checklist.
when needed
Problems
The service is most valuable when the team can identify the specific control gap, decision, deliverable, or
recovery need rather than requesting generic capacity.
Scope
The exact scope depends on the maturity of the work, the quality of the inputs, the sponsor’s procedures,
the review model, and the target milestone.
Deliverables
Deliverables should be confirmed at kickoff and linked to defined sponsor decisions, review cycles, and downstream handoffs.
Client inputs
The sponsor does not need every detail finalized before kickoff, but approved decisions, open questions, source owners, reviewers, and deadlines must be distinguishable.
Process
1. Confirm the purpose, current state, intended use, milestone, stakeholders, responsibilities, systems or vendors, and agreed deliverables.
2. Review available source materials, prior decisions, procedures, evidence, and open issues; issue a focused gap and dependency list.
3. Develop the work plan, specifications, document, assessment, or control package included in scope.
4. Coordinate review through named sponsor and cross-functional decision owners and maintain a controlled open-item and comment process.
5. Perform the agreed technical, quality, consistency, or operational checks and document remaining risks or limitations.
6. Prepare the approved handoff, implementation, submission, remediation, archive, or next-step package as defined in scope.
Considerations
The work should remain proportionate to the risk and intended use, follow the sponsor’s controlled process, and preserve clear sponsor decision authority.
Engagement options
BioBoston leads the defined scope from assessment and planning through drafting or execution, review, quality control, and handoff.
BioBoston addresses a specific section, decision, backlog, finding, vendor issue, or stalled deliverable without expanding the engagement unnecessarily.
BioBoston provides an objective second-line review, oversight role, or embedded specialist while the sponsor or another vendor retains primary execution.
RELATED SERVICES
Use audit evidence within the sponsor's ongoing risk-based oversight of delegated activities.
Simulate regulator requests, interviews, logistics, and response management after material audit gaps are addressed
Investigate findings, develop corrective and preventive actions, review implementation evidence, and verify effectiveness.
Perform a focused audit of Trial Master File completeness, quality, traceability, and inspection readiness.
Expertise
Auditor experience should match the audit type, study phase, product, therapeutic or device context, auditee, systems, geography, language, prior history, and highest-risk processes.
RESOURCES
Explore the following resources for additional insights and information relevant to this service.
A planned checklist for objective, criteria, risk, scope, sampling, requests, interviews, logistics, confidentiality, reporting, and follow-up.
A planned guide to quality systems, capabilities, procedures, systems, subcontractors, data, study controls, findings, and decision criteria.
A planned tool for criteria, evidence, risk, scope, cause, actions, implementation, effectiveness, and closure.
FAQs
Potential scope includes investigator sites, CROs and clinical vendors, laboratories, technology providers, studies, processes, systems, sponsor functions, and follow-up audits. The exact criteria, access, geography, and auditor profile must be defined.
Some audits can be remote or hybrid when records, systems, interviews, confidentiality controls, and sampling objectives can be achieved. Onsite work may be preferable for facilities, source records,
processes, or risks that cannot be assessed adequately remotely.
Grading should follow the sponsor’s approved procedure and consider applicable criteria, objective evidence, participant and data risk, systemic impact, recurrence, detection, and control effectiveness.
Yes. Review can assess whether the response addresses the finding, affected scope, root cause, corrective and preventive actions, owners, deadlines, implementation evidence, residual risk, and effectiveness.
No. Monitoring is an operational trial-management activity focused on ongoing study conduct and data review. Auditing is an independent quality-assurance assessment against defined criteria.
No. An audit samples defined evidence at a point in time and cannot guarantee that every issue is identified or that an authority will reach the same conclusion.
PROJECT FORM
Share the audit type, study or program, auditee, location, systems, known risks, prior findings, preferred timing, and reporting deadline. A BioBoston team member will review the request and follow up regarding fit and possible next steps.
Please do not submit confidential, patient-identifiable, or proprietary information through this form.
A productive first discussion identifies the audit objective, criteria, auditee, study or process, risk, prior history, access, location, dates, and report needs. BioBoston can then propose the scope, auditor profile, methodology, and follow-up model.
