The feasibilities we conduct are quick and at the same time realistic and highly reliable. This is possible with our own investigator database which we have accumulated over the years of operation, established two-way communications with the sites, regulatory authorities and the industry experts, and the cooperation culture which we have been carefully cultivating since starting our first project.
Your study synopsis will be skillfully translated into a list of questions, some of which we already have the answers for, and the rest will be addressed directly to the best sites and industry experts. The accurate and representative feasibility report, capable of becoming the cornerstone of your project’s strategy, will be delivered on time.
We always select the best sites, finding a perfect balance between patient access and site personnel engagement, and never compromise on study protocol and ICH-GCP compliance requirements.
Despite the continuous changes in regulatory climate towards greater harmonization and standardization, navigating the diverse national regulatory landscapes can be a challenging task to complete. GCT maintains strong local expertise through dedicated local specialists, securing proactive regulatory awareness for our clients.
- Obtaining clinical trial approval
CTA procedures can be very complex. This makes us even more proud to maintain a 100% submission/approval ratio. We always base the CTA strategy upon the solid understanding of the regulatory requirements, procedures, and practices, which is derived from our real-life experience. This allows us to make the submissions complete and compliant, facilitating the review and approval.
- Import and export licenses
Taking charge of obtaining all necessary approvals, customs clearance and courier coordination, our dedicated personnel will perform the importation the study drug and related materials such as lab kits, devices and anything else necessary for the successful completion of the project, and export of biosamples. Learn more about logistics & warehousing services.
- Drug / devices registration / marketing authorisation
Our regulatory personnel will review, develop, perform translation and adaptation all necessary documents, put together the registration dossier, plan and follow up on the submissions and applications to national and global authorities.
We will select global/local insurance providers and coordinate patients/liability insurance compliant to the legal requirements.
We are in touch with the regulatory authorities, medical and pharmaceutical expert boards, institutions and key opinion leaders locally in all countries and regions of operation. For complicated projects, we are able to provide the necessary navigation to build a reliable scientific strategy.
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Study start-up support is only one of the services that we provide
See the full service list