Gct cro

Hii sir, I wants to know the names About the Services of the GCT Will you Please provide me the Information About the Services of the GCT ?

[sumit]

GCT is a Contract Research Organization Combining Global Quality Standard With Local; Expertise ,teamwork And Professionalism

Services
Medical writing
Clinical study synopsis, protocol, IB, ICF, CRF design
Feasibility analysis and site selection
Regulatory support
Obtaining clinical study approval, import and export licenses, local insurance, drug registration, scientific advice
Translation and cultural adaptation of essential and other clinical study documentation
Investigators’ meeting organization
Global and regional project management
Site administration
Clinical trial monitoring
Phase I, Phase II-III, Phase IV/Post approval, BE>/PK; novel biopharmaceuticals, medical devices, combination products, generics, biosimilars and biobetters
Clinical trial logistics
Study drug import, biological samples export, and clinical study materials’ distribution to the investigative sites
See warehouse and logistics services for details
GCP and FDA compliant warehousing in Russia
Ambient, refrigerated and frozen
See warehouse and logistics services for details
Quality Assurance and Quality Control
Principle investigators’ and site contracts and payments
Local SAE management and medical monitoring
Hotline 24/7
Data and Safety Monitoring Board
Vendor management
Central laboratory, Central Imaging Review, Central ECG Review, QP release, EudraVigilance, others
Data management and biostatistics
e-CRF and paper CRF
Interim and final clinical study reports


Contact details :
GCT
Nataliya Katsnelson
Business Development Manager
telephone: +1 609 921 6868
GMT – 05:00 Eastern time
256 Bunn Drive, Suite 6, Princeton, NJ 08540