In today’s highly regulated clinical research environment, effective regulatory support in clinical trials is more important than ever. Sponsors and Contract Research Organizations (CROs) need research sites that not only understand the regulatory landscape but also have the infrastructure and expertise to meet it confidently. That’s where South Florida Clinical Research Institute (SFCRI) excels.

Our comprehensive regulatory support ensures full compliance with FDA regulations, Good Clinical Practice (GCP) guidelines, Institutional Review Board (IRB) oversight, and sponsor-specific documentation standards—keeping your study audit-ready at every phase.

What Regulatory Support Means in Clinical Research

Regulatory support in clinical trials encompasses all activities required to ensure that a study is conducted ethically, legally, and scientifically. This includes:

  • FDA compliance for investigational product handling, reporting, and documentation
  • IRB submissions and correspondence to gain and maintain approval
  • GCP adherence, ensuring protocols protect participant safety and data integrity
  • SOP enforcement, ensuring staff follow consistent, approved procedures

When a site fails to meet these standards, it jeopardizes not only participant safety but also the credibility of trial data. At SFCRI, our systems are designed to eliminate that risk.

SFCRI’s End-to-End Regulatory Capabilities

We support our sponsors throughout the entire trial lifecycle with dedicated regulatory coordination. Our services include:

  • IRB Management: We handle initial IRB submissions, amendments, continuing reviews, and safety reporting.
  • Regulatory Document Preparation: We maintain accurate and up-to-date investigator site files, regulatory binders, delegation logs, and training records.
  • Protocol Deviation Tracking: Every protocol deviation is documented, evaluated, and reported per regulatory timelines.
  • SAE/AE Reporting: Serious and non-serious adverse events are tracked and reported promptly through structured workflows.

These tasks are managed by trained Clinical Research Coordinators (CRCs), under the supervision of experienced Principal Investigators (PIs) and regulatory staff with decades of combined experience.

Inspection Readiness and Quality Control

SFCRI places a strong emphasis on inspection readiness. We implement:

  • Routine internal monitoring to identify gaps before external review
  • Mock audit procedures to simulate sponsor or FDA inspections
  • Proactive document audits, ensuring complete, legible, and signed/dated source data
  • CAPA (Corrective and Preventive Action) plans, when needed, to address potential non-compliance

This rigorous internal oversight ensures our trials are always prepared for audits by sponsors, CROs, or regulatory authorities.

Document Management and Compliance Tools

Our regulatory infrastructure supports seamless documentation and audit trails. We use:

  • Electronic Trial Master File (eTMF) systems for central document access
  • Version control processes for protocols, informed consent forms, and safety logs
  • ALCOA-C principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete) to guide data documentation
  • Secure document archiving to maintain accessibility and confidentiality

Whether your study requires paper-based logs or fully digital regulatory platforms, we adapt to meet your compliance needs.

Experienced Personnel and Ongoing Training

Compliance isn’t just about systems—it’s about people. Our team includes:

  • Board-certified PIs with experience in regulatory inspections
  • CRCs trained in ICH-GCP, SOPs, and sponsor-specific requirements
  • Regulatory specialists who track submissions, deadlines, and document versions

Staff undergo annual training refreshers, protocol-specific briefings, and role-based regulatory education to keep pace with changing industry requirements.

Benefits for Sponsors and CROs

By partnering with SFCRI, sponsors benefit from:

  • Faster site start-up timelines due to pre-established document templates and workflows
  • Confidence in inspection readiness, backed by internal audits and quality systems
  • Transparent document tracking, version history, and compliance logs
  • Reduced sponsor burden through coordinated IRB and SAE submissions
  • A partner who understands and anticipates sponsor and CRO documentation expectations

We reduce regulatory risk while improving your speed to database lock.

Conclusion: Partner with SFCRI for Reliable Regulatory Execution

Regulatory compliance is non-negotiable in today’s clinical trial landscape. At SFCRI, we make it seamless. Our comprehensive regulatory support in clinical trials empowers sponsors to stay compliant, audit-ready, and focused on advancing science.

Contact our Business Development team today to learn how SFCRI’s regulatory infrastructure, experienced team, and quality systems can support your next clinical trial.