Quality Data Services, Inc.

Clinical Management

Full service project and site management dedicated to quality and effective communication

Clinical Management

Clinical Management

Clinical Project Management

Our office-based Clinical Project Management staff has many years of clinical experience and industry knowledge to ensure your project runs effectively and efficiently. Our Project Managers understand our clients' reliance on effective communication and quality. A dedicated Project Manager is assigned to run each trial from start to finish.

From inception to completion:

  • Dedicated Project Manager
  • First-line site management
  • Proactive issue identification and corrective action planning
  • Overall responsibility for quality, timelines, budget adherence
  • Performs as a member of your team

Clinical Monitoring

QDS' Clinical Monitors have at least 8 years of experience in the field, and are regionally based to provide maximum efficiency, and to develop effective investigator site relationships. Study assignments are based on relevant therapeutic experience to ensure low query rate and true understanding of the clinical research protocol and endpoints. QDS monitors are proficient in the use and methods of Electronic Data Capture.

Services include:

  • Site Qualification Visits
  • Initiation Visits
  • Interim Monitoring Visits
  • Study Close Out Visits
  • Drug Accountability
  • Site Management

Process

Study Start-Up

  • Site Feasibility Assessment
  • Investigator Assessment
  • Establishment of Operations Manual
  • Communications & Monitoring Plan Development
  • Source Document Creation
  • Site Qualifications
  • Regulatory Document Collection and IRB/EC Submissions
  • Third-Party Vendor Selection
  • Investigator Meeting Presentations
  • Site Initiations
  • Clinical Supply Distribution

Project Management

  • Oversight of Study Team
  • Site Management and Monitoring
  • Proactive Issue Identification
  • Corrective Action Planning
  • Newsletters and Study Updates
  • Evaluation of Clinical Data
  • Financial Oversight and Management of Study Budget
  • Grant Payments
  • Regulatory Document Maintenance
  • Ongoing Site Training

Study Close-Out

  • Assistance with Query Resolution
  • IP Accountability & Return/Destruction
  • IRB Close Out Reporting
  • Close Out Monitoring Visits
  • Regulatory Document Reconciliation