Ensuring Regulatory Excellence in Every Phase of Your Study
In today’s competitive and highly regulated research environment, clinical trial compliance is essential to safeguard patient safety, maintain data integrity, and achieve successful regulatory submissions. Even a single overlooked compliance gap can delay your trial, increase costs, or jeopardize approval.
At BioBoston Consulting, we are clinical trial compliance gap assessment experts, helping sponsors, CROs, and research institutions identify, address, and prevent compliance risks before they impact your study.
Why Clinical Trial Compliance Matters
Global regulatory bodies such as the FDA, EMA, and ICH set strict guidelines for clinical trials, covering Good Clinical Practice (GCP), patient safety, and data reliability. Non-compliance can lead to:
- Trial delays or termination.
- FDA Form 483 observations or EMA inspection findings.
- Rejection of clinical trial data during submissions.
A comprehensive compliance gap assessment ensures your trial is fully aligned with global regulatory expectations and ready for inspections.
Our Clinical Trial Gap Assessment Approach
BioBoston Consulting provides a systematic, end-to-end gap assessment process to ensure your trial meets GCP and regulatory standards.
Our process includes:
- Regulatory Requirement Review – Mapping trial protocols, SOPs, and processes against FDA, EMA, and ICH guidelines.
- Document & Data Integrity Audit – Ensuring completeness, accuracy, and ALCOA+ compliance.
- Site Readiness Assessments – Evaluating investigator sites for GCP adherence.
- Staff Training and Competency Review – Confirming personnel qualifications and GCP knowledge.
- Risk Prioritization – Highlighting gaps that pose the highest compliance risk.
- Remediation Action Plan – Providing step-by-step solutions for closing compliance gaps.
- Mock Regulatory Inspections – Simulating FDA or EMA audits to ensure readiness.
Key Areas We Assess in Clinical Trials
Our clinical trial compliance gap assessment services cover:
- Protocol Compliance – Ensuring study execution matches approved protocols.
- Informed Consent Process – Documenting ethical patient enrollment.
- Safety Reporting – Compliance with adverse event reporting timelines.
- Trial Master File (TMF) Management – Maintaining inspection-ready documentation.
- Data Management and Monitoring – Safeguarding accuracy and reliability.
- Vendor and CRO Oversight – Ensuring third parties comply with GCP.
Why Choose BioBoston Consulting as Your Compliance Partner
- Deep Regulatory Expertise – Extensive knowledge of FDA, EMA, and ICH clinical trial requirements.
- Tailored Solutions – Customised gap assessments based on your trial’s size, phase, and complexity.
- Proven Track Record – Clients consistently achieve successful inspections and submissions.
- Global Perspective – Experience managing multi-country trial compliance.
The Risk of Ignoring Compliance Gaps
Unaddressed compliance issues can escalate, affecting data credibility and patient safety. Proactive gap assessments minimize risk, protect study timelines, and improve overall trial quality.
By working with clinical trial compliance gap assessment experts like BioBoston Consulting, you can ensure your study remains on track and inspection ready.
Continuous Readiness – Not Just a One-Time Check
Regulatory expectations evolve throughout the trial lifecycle. We provide ongoing compliance monitoring to maintain readiness from trial initiation to closeout, ensuring no surprises during inspections or submissions.
Start Your Compliance Gap Assessment Today
Do not let hidden compliance gaps derail your clinical trial. Partner with BioBoston Consulting—your trusted clinical trial compliance gap assessment experts—to safeguard your research and ensure regulatory success.