Clinical Operations

Clinical Operations

PHACT’s Clinical Operations leverages our partnering philosophy to deliver effective, end-to-end collaboration, training, and resource planning. Our proficient and experienced team members engage quickly and provide strategic thinking – ensuring quicker start-up times, superior quality, and the most efficient delivery at every phase of the trial.
Comprehensive communication throughout all phases of the clinical trial is essential to building successful partnerships – with Sponsors, research sites, and patients. Our dedicated teams are designed to serve as an extension of your team and provide unrivaled support at every stage of the drug development process.

We share common goals and expectations regarding drug development and are committed to your success. PHACT’s Clinical Operations provides support in a number of critical areas, including:

  • Project Management
  • Regulatory Submissions
  • Investigator Selection
  • Clinical Monitoring
  • Clinical Trial Management

Regulatory Submissions

PHACT delivers a well-coordinated, collaborative approach in every aspect – from writing informed consents, to translations, to working with regulatory authorities and ethics committees. We address:

  • Regulatory Agency and IRB/EC submissions.
  • Procurement of Import/Export license, as applicable.
  • Compilation of initial submissions, amendments, notifications, and closeout submissions.
  • Collection, review, and approval of site essential documents.

Clinical Trial Management and Monitoring

The logistics to produce high-quality data to support your product’s claims of efficacy and safety are numerous. Our clinical monitors will help you get faster, more efficient investigator site support and monitoring. They have local knowledge about country-specific customs and regulatory requirements, ensuring that investigators are:

  • Appropriately selected
  • Trained to complete the proposed protocol-driven research
  • Able to observe proper patient protection standards