Gct CRO
Study start-up, clinical development services and regulatory affairs.
What they do
From their website
/services
- Scientific & Medical Writing (opens in a new tab)
- Project Management (opens in a new tab)
- Vendor Management (opens in a new tab)
- Warehouse and Logistics (opens in a new tab)
- Quality Assurance and Quality Control (opens in a new tab)
- Trial Master File management (opens in a new tab)
- Safety Management (opens in a new tab)
- Software and technologies (opens in a new tab)
- EU Legal Representation (opens in a new tab)
- GDPR Representation and Data Protection (opens in a new tab)
- Drug/device Registration (opens in a new tab)
- Feasibility Analysis And Site Selection (opens in a new tab)
- Study-Specific Trainings (opens in a new tab)
- Kick-Off and Investigators' Meeting (opens in a new tab)
- Clinical Trial Insurance Management (opens in a new tab)
- Obtaining clinical trial approval (opens in a new tab)
- US FDA regulatory support (opens in a new tab)
- Ethics Committee and IRB support (opens in a new tab)
- Import and export licenses (opens in a new tab)
- Translations and Adaptations (opens in a new tab)
Show all (51)
/services
- Amendment and Notification Submissions (opens in a new tab)
- Orphan Drug Designation (opens in a new tab)
- TMF plan (opens in a new tab)
- Site Master File and binders (opens in a new tab)
- Essential Documents Management (opens in a new tab)
- Medical Monitoring Plan (opens in a new tab)
- Medical Review of eCRFs (opens in a new tab)
- Scientific and Medical Support (opens in a new tab)
- Local Medical Monitoring (opens in a new tab)
- Statistical Analysis Plan (opens in a new tab)
- Sample Size Calculation (opens in a new tab)
- Randomization schedule development (opens in a new tab)
- Presentation of results in TFLs (opens in a new tab)
- Interim and final statistical report (opens in a new tab)
- Electronic Data Transfer (opens in a new tab)
- Statistical data analysis and Report (opens in a new tab)
- Data Protection Officer (opens in a new tab)
- GAP Analysis (opens in a new tab)
- Marketing Authorization Application (opens in a new tab)
- CE marking (opens in a new tab)
- Marketing Authorization Maintenance (opens in a new tab)
- SDTM, SDRG, ADaM, ADRG (opens in a new tab)