Monitoring

Academic research centers with investigators developing grant-funded and/or investigator initiated research projects can benefit from BRANY’s monitoring services. Whether you have a single or multi-site study, best practices indicate that study monitoring results in better quality data and regulatory compliance. 

BRANY has a staff of clinically experienced and certified CRAs who can act as independent monitors, or as a supplement to your existing team. Well-versed in FDA regulations and GCP guidelines, our monitors will provide the highest quality oversight of your research study.

Our monitors will ensure that the research trial is conducted and documented in accordance with regulatory requirements. We provide detailed feedback to investigators on any deviations, errors, omissions or illegibility of documents and materials.

Monitoring services include:

  • Regulatory document inventory and review—our team carefully inventories and reviews all documents, including protocols, amendments, investigators’ CVs, IRB correspondence, investigator drug brochures, informed consents, financial disclosures, IND safety reports, serious adverse event reports, and Delegation of Authority forms, among others.
  • Verification that the investigator is following the current IRB approved protocol; that all study subjects have documented informed consents on file and in the medical record; subjects enrolled met eligibility criteria; source documents are accurate and complete; unanticipated problems involving risks to subjects or others are appropriately reported.
  • Closeout visits
  • Investigational product accountability—our professional monitors will evaluate everything from shipping and transportation procedures, to handling, storage and managing inventory of the investigational product. We will ensure the entire process is documented.

For more information please contact Carmela Houston-Henry at (516) 470-6979 or choustonhen@brany.com.