Our team of Certified Clinical Research Associates (CCRAs) and Project Managers are poised to provide a variety of contract services to ensure the integrity and success of your trial.

Whether your project requires the experience of a medical writer for protocol development, the professional oversight of a certified clinical research associate, guidance in preparation of a regulatory submission, or tactical planning and distribution of your study specimens, our CCRAs support you with a suite of value-added services:

Medical & Technical Writing of HIPAA Compliant Study Documentation

• Protocol Development
• Consent Design
• Case Report Form
• Investigator Brochures
• Patient Information Sheets
  

Regulatory Support

• Ethics Committee Submissions (IRB, IEC, MoH)
  
• Investigator Site Compliance Evaluations
  

Clinical Data Services

• Data Analysis
  
• Custom Reporting via Remote Data Access
  
• Electronic Data Capture (EDC)
  
• Query Generation, Management & Tracking
  
• Site Management Services
  
• Investigative Site Qualification & Selection
  
• Study Initiation
  
• Interim & Close-out Monitoring

Clinical Trial Supplies

• Collection Kit Design & Manufacturing
  
• Instruction Manual Development & Training
  
• Testing Requisition Forms
  
• Transport Documentation
  
• Kit & Transport Packaging Materials (IATA compliant)
  
• Global Distribution

Specimen Management

• BioStorage Services (Short & Long Term)
  
• Barcode & Label Design
  
• Custom Aliquoting & Processing
  
• Testing
  
• Global Distribution

Whether you need complete Clinical Trial Management or support in selected areas, please consider the time savings and efficiencies of outsourcing your requirements to ProMedDx.