Research Monitoring

BRANY’s 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 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

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.

Flexible Monitoring Models to Fit Your Needs

Whether you need full-service monitoring for a multicenter trial or targeted support for a single-site study, BRANY offers customizable monitoring solutions to meet your specific goals. From pre-study site qualification visits to interim monitoring and close-out activities, our team adapts to your workflows to ensure efficient oversight without disrupting site operations. We work collaboratively with research teams to promote best practices and reduce regulatory risk at every stage of the trial.