Services

Full-service site management and support across the life of a clinical trial, from feasibility review through close-out.

Site Management

Day-to-day operational running of the study at the site.

  • Protocol feasibility and site qualification visits
  • Coordinator staffing and protocol-specific training
  • Visit scheduling and participant retention
  • Investigational product accountability and storage logs
  • Hosting monitoring visits and responding to findings
  • Study close-out and records retention

Regulatory Support

Assembling and maintaining the documentation a study is audited against.

  • IRB submission packages and continuing review
  • Investigator site file setup and upkeep
  • Delegation logs, CVs, and training records
  • Protocol amendment and consent-form version control
  • Safety reporting workflows and deviation logs

Patient Recruitment

Finding eligible participants and keeping them enrolled through the schedule.

  • Pre-screening against inclusion and exclusion criteria
  • Community and referral outreach
  • Informed consent conducted without time pressure
  • Retention planning: reminders, transport, visit-window flexibility
  • Screen-failure tracking and enrollment reporting

Data Management

Getting what happened at the visit into the database correctly and quickly.

  • Source documentation completed against the visit
  • Electronic data capture entry within sponsor timelines
  • Query resolution and turnaround tracking
  • Source-to-EDC reconciliation ahead of monitoring
  • Protocol deviation identification and documentation

How a study moves through our site

  1. Feasibility

    We review the protocol against our population, staffing, and equipment, and give a direct answer on whether the site is a fit.

  2. Startup

    Regulatory package assembly, ethics submission, contract and budget execution, staff training, and site initiation.

  3. Enrollment

    Pre-screening, consent, and randomization against the agreed timeline, with enrollment reported at an interval the sponsor sets.

  4. Conduct

    Visits run to protocol, source documented promptly, data entered within agreed timelines, monitoring visits hosted and findings tracked and addressed.

  5. Close-out

    Final data cleaning, query resolution, product reconciliation, and records handover and retention.

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