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CLINICAL SERVICES – Contract Services
Clinical Trial Services and Medical Writing



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 clinical 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:

Technical & Medical 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.


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DID YOU KNOW?
Every data point entered into PIMS™, our custom designed information management system, is validated through automated quality control procedures by a series of independent verifications.