Clinical Operations

|Clinical Operations
Clinical Operations2018-06-07T20:44:25+00:00
What We Do

Driving high-quality outcomes with accountability and transparency.

Our experienced team members provide value by embracing their partnership role and supporting you with issue identification, proposing and deploying mitigation strategies, and following through to resolution. We constantly examine the best way to conduct your clinical trial to facilitate rapid study start, ensure proper trial oversight, maintain quality outcomes, and achieve your trial timelines.

Clinical Operations experience you can count on.

0+ years
Of experience with drug, biologic, & device study management & monitoring
0+ years
Of Phase 1-4 interventional, non-interventional, registry, & device experience
Individual therapeutic areas & unique study designs implemented

Count on our clinical expertise, creative thinking, and quality-based approach to help you:

  • Meet timelines with targeted patient recruitment and retention
  • Reduce site and investigator burden by implementing robust identification, feasibility, and selection standards
  • Identify challenges and opportunities for each site with operationalized protocol development and review
  • Lead with data-driven project management through consistent review of performance and trends
  • Ensure study start-up, maintenance, and close-out are performed per ICH/GCP, local regulations, and SOPs generated from our ISO 9001:2015 certification
  • Develop a customized monitoring approach with a full spectrum of capabilities ranging from 100% SDV to complete Risk-Based Monitoring (RBM)
“I chose Firma because their team demonstrated a high level of industry knowledge, asked great questions to ensure we had thought of potential operational strategies, and took ownership in supporting our trial.”

Learn how these clients relied on Firma Clinical Operations to provide quality trial oversight, produce accurate file reconciliation, and facilitate timely database lock.

Learn how Firma Clinical Operations can help manage your clinical trials operations and speed time-to-database-lock.