Regulatory compliance in clinical research is essential. BRANY can help research sites ensure that research is carried out in accordance with applicable regulatory requirements including those of the Food and Drug Administration (FDA), ICH and OHRP. Regulatory agencies routinely conduct audits of research sites to evaluate adherence to current regulations; BRANY can help you be prepared.
Research Billing Compliance
It’s not enough to conduct a Medicare Coverage Analysis. You have to maintain quality assurance and systems to ensure your analysis is applied properly. We can conduct an audit and identify areas of risk in your billing process. We can also evaluate whether you are adhering to your clinical trial budget, and what you can do to address any issues.
Research Trial Compliance
BRANY’s compliance staff consists of experts who are knowledgeable in FDA regulations, ICH and OHRP guidelines. Our team will customize an audit plan to meet your needs.
Typical areas of focus are:
- Institutional Review Boards—we will evaluate your IRB program by reviewing Standard Operating Procedures (SOPs), documentation, meeting minutes, communications, continuing reviews, approval letters and other materials. We will also conduct interviews with IRB members, investigators, research office staff and others involved in the workflow to understand workflow and workload, processes, timeliness of reviews and filings, and other issues that may impact your IRB’s efficiency and productivity.
- Investigators—whether it is a routine evaluation or an audit “for cause,” our discreet analysts can review investigator practices to ensure compliance with approved protocols and regulatory requirements. We support IRBs and compliance officers by providing independent, third party review and proactive recommendations for avoiding FDA warning letters.
- Outsourced research compliance—for smaller research programs without a full time compliance officer, BRANY can offer expert research compliance services. These services can include regularly scheduled and customized compliance audits, which can identify potential risks and problems before a regulatory agency seeks action. For community hospitals or medical groups, our outsourced research compliance services are a cost-effective way of ensuring regulatory compliance.
- Research program evaluation—if your organization is interested in starting a clinical trial office or a research program, or if you have a loose infrastructure for a research program, we can conduct as assessment to understand and establish Standard Operating Procedures (SOP), conflict of interest committees, privacy policies, mechanisms for communications with other departments (pharmacy, lab, etc.), among other requirements. Our analysis starts with interviews with the key stakeholders to identify issues with the process. The goal is to identify gaps and offer systematic approaches to establishing or improving clinical trial office efficiencies and compliance.