Services

Contact

Address:
Gaea | Clinical Ltd
One Broadcarr Road
Macclesfield
SK11 0AQ
United Kingdom

Gaea Clinical Trial Services LLC
97343, Saint-Petersburg,
ul. Matrosa Zheleznyaka, 57A, 122N

Tel: +44 1625 413 900
Fax: +44 1452 798 222
Mobile: +49 151 51 11 19 31
Email: ngg@gaea.co.uk

About Us

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


Our Recent Clients

Glycotope GmbH
DNAtrix Inc.
Genelux GmbH
Vifor Pharma UK Ltd
CureVac GmbH
MucoVax GmbH
BN ImmunoTherapeutics
Oncolytics Biotech Inc.
Cougar Biotech Inc.
Agios Inc.
Drug Royalty International
Allos Therapeutics Inc.
The Medicines Company, Inc.
Adventrx Inc.
Baxter Bioscience, Inc.
Merck Serono Oncology

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