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