Clinical Trial Management

Libra is a full service Contract Research Organization (CRO) offering services for all your clinical trial needs. We can perform your entire clinical study or integrate with your team. We assign a project manager to every project and provide you with a single point of contact. Libra project managers are responsible for management of all clinical trial activities. We are dedicated professionals capable of handling any size project.

Clinical Research

  • Clinical Strategy
  • Protocol Development
  • Case Report Form (CRF) Design
  • Informed Consent
  • Presentation and Journal Article Preparation
  • Clinical Report Generation
  • SOP Development

Data Management

  • Database Design, Validation & Maintanence
  • Designed Automatic Edit Checks
  • Data Management, Data Cleaning & Query Resolution
  • Paper CRF or EDC Management
  • 21 CFR Part II Compliant
  • Safety Monitoring
  • Data Monitoring Committee (DMC) Management
  • Clinical Events Committee (CEC) Management
  • Study Reports
  • Core Lab Management
  • Randomization

Site Qualification & Monitoring

  • Site Qualification & Initial Visit
  • Assistance with Preparation for Onsite Monitoring Visits
  • Clinical Monitoring – Meets FDA & ICH GCP
  • Timely and Thorough Monitoring Reports
  • Site Close-out Visits

Site Management

  • Site Management During Enrollment / Follow Up Phase
  • IRB Approvals
  • Device / Product Tracking
  • Payment Tracking
  • Document Management
  • Site Training
  • Contract Negotiation
  • Investigation Agreement
  • Regulatory and Patient Binders
  • Master Study File Maintenance
  • Site Correspondance

Statistical Services

  • Clinical Protocol Preparation
  • Sample Size / Statistical Power Determination
  • Development of Statistical Analysis Plans (SAP) and Analysis
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