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Regulatory Support
Project Management and Administration
Data Management
Statistics and Programming
Data Warehousing
Clinical and Proposal Writing
We provide full support regarding all regulatory requirements for our projects, including:
  • Obtaining Business Associates (BA) Agreements and Certificates of Confidentiality (CoC).
  • Ensuring Institutional Review Board (IRB) and Food and Drug Administration (FDA) compliance, including step-by-step guidance in the development of informed consent forms and Serious Adverse Event (SAE) reporting procedures.
  • Preparing progress and safety monitoring reports for external Data Safety and Monitoring Boards (DSMB) and provide representation during meetings.
  • Ensuring the best Quality Assurance and Quality Control (QA/QC) procedures are in place and are continually monitored and all study activities are compliant with Good Clinical Practices (GCP).