Gaea has an enthusiastic, multi-functional, clinical trial management team in Europe, Israel and Russia with the capability to work either as the sponsor's CRO or to work alongside the sponsor-chosen CRO to help meet the study targets, on time and with high-quality outcomes. We have only experienced CRAs and Trial Managers, so we have low staff turnover. Our full services offer includes regulatory, biostatistics, data management, pharmacovigilance, medical monitoring and medical writing.
Gaea as Your Clinical Consultancy
Accelerating Site Start-Up With Your CRO
Ensuring effective site selection
Helping the CRO to plan and execute parallel tasks
Building momentum, e.g. national kick-off meetings
Boosting Patient Enrolment
Supporting the CRO's CRAs
Assessing site issues with the study team and CRA
Defining and executing a site-specific plan
Representing the Sponsor's interests to deliver on target and on time
Gaea as Your CRO
Site Feasibility and Start-Up
Database of thought leaders in disease populations
Design and pre-testing of feasibility questionnaires
Emphasis on effective site selection
Parallel task execution on start-up, regulatory and contracts
Site Management
National CRAs and Trial Managers experienced in country-specific issues of site selection, qualification, initiation, monitoring and close-out
In-depth knowledge of many tumour types
Practised in complex blinded/unblinded trial designs
IMP importation support and depot selection/management
Regulatory, Pharmacovigilance and Quality Assurance
Available for the EU, Russia and the Ukraine
Experienced in submissions to the central and local IRB/IECs
Audited Trial Master File storage facilities
MyFax� system available for 24/7 reporting of SAEs
Dedicated QA Manager to ensure exceptionally high standards
Gaea Support Functions
Strong events management team for national investigator meetings and enrolment workshops in Europe and Russia
Expert IT support with PowerPoint, design and production skills
Management of all external resources
Experience with multiple vendors (e.g. IWRS, central laboratories, EDC)
IMP importation support and depot selection and management
Generation, updates and maintenance of SOPs
Oncology Medical Monitor availability