Core Competencies – the Sponsors perspective

Our priorities

  • Highly experienced PI 130+ clinical trials in phases I through IV
  • PI maintains first level contact in all medical and regulatory issues
  • GCP certified medical staff
  • Quick and easy access to all essential documents to enable smooth submission process
  • Access to advanced digital imaging (Spiral CTscan, MRI, Bone Scan, DXAscan) and online submission to central review institutions
  • RECIST 1.0 and 1.1 analysis
  • Digitally temperature-controlled and locked storage of investigational medical products
  • Immediate data capture and experience in current eCRF and IVRS applications
  • Prompt query resolution
  • SAE reporting within 24 hours of notification by investigator
  • Certified associated laboratory
  • Experience with processing and shipment of biologic specimen
  • Pharmacokinetic sampling
  • Wireless high speed internet access for monitors and facilities for monitoring
  • 12 lead ECG, centrifuge, refrigerated centrifuge, 6 treatment units for i.v. applications
  • Source data is provided as printed records and maintained throughout to ensure accuracy and readiness prior to monitoring