Research Auditing & Monitoring

BRANY’s GCP auditing and clinical trial monitoring services enable researchers to maintain the highest standards of compliance and ethical research conduct.

Experienced Team

BRANY offers cost-effective and high quality GCP auditing and clinical trial monitoring.

Our team members have a deep understanding of FDA regulations, ICH standards, and OHRP guidelines. BRANY’s Quality Assurance (QA) team offers your staff methods for mitigating risks and ensuring compliance with relevant laws, regulations, and internal policies

Tricia Singh, RPA-C, CCRC, Senior Director, Quality Assurance & Monitoring
Haleigh Waite, CCRA, Senior Research Compliance Auditor
Leah Persky, MS, CCRC, Clinical Research Compliance Auditor
Christopher Chadwick, MPH, Quality Assurance & Monitoring

Good Clinical Practice (GCP) and Compliance AuditingAudit is defined as, “A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s)” (ICF E6 Section 1.6).

BRANY’s GCP audits provide a compliance snapshot. The purpose of auditing a trial is to review the overall processes for some or all of the subject files to:

• Ensure the protection of subjects enrolled in clinical trials
• Increase confidence that the data collected and subsequently submitted is valid
• Confirm eligibility criteria per protocol was met for subjects enrolled
• Ensure proper documentation of the informed consent process
• Verify compliance with the regulations, the IRB’s requirements, and good clinical practice (GCP)

Outsourced Research Compliance

Institutions may lack resources to be able to conduct GCP or compliance audits. Our team can provide this service and can help to identify and mitigate any developing systemic issues. Our auditors have the lens of “eagle-eyes” that can identify problems and compliance issues and can give recommendations to improve study conduct.

The coaching and mentoring philosophy inherent in our approach to research compliance creates an educational experience for all involved. This enables your team to gain new knowledge and skills, which strengthens the research skills at your institution.

Clinical Trial Monitoring

MonitoringMonitoring is, “The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s)” (ICH E6 Section 1.38). is a Quality Control (QC) function. The purpose of continuous and routine monitoring is to review all study procedures and data to:

• Protect the rights, safety, and welfare of subjects involved in trials subject to regulation(s)
• Verify the accuracy and reliability of trial data submitted in support of the research
• Assess compliance with regulations governing the conduct of the trial

Our team provides high quality study monitoring by careful and meticulous review of study documents that include but not limited to protocols, amendments, investigator drug brochures, drug/device accountability, informed consents, financial disclosure forms, adverse event reporting (serious and nonserious), concomitant medication log, delegation of authority log, and investigators’ CVs.

FDA Inspection Guidance and Records Preparation

Preparing study files for FDA visits can be challenging, especially if you do not have the right resources. Our experienced team can assist and give guidance for these types of inspections.