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