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

Site Selection

From Gaea's extensive experience, we have a large database of thought leaders in each disease population to assist us with the selection of key sites in a new clinical trial.

Factors that we consider important in country selection include:

  • Prevalence data for the patient population in a country as one potential marker of patient availability
  • The suitability of healthcare in countries (e.g. standard of care, medical resources)
  • Examples from prior studies
  • Timelines for clinical trial regulatory approval
  • Usual site contract issues
  • Any issues with the Investigational Medicinal Product (e.g. an oncolytic virus and pharmacy concerns about using a virus)

Factors that we consider in site selection:

  • Identification of a 'National Co-ordinator', assessed activity in the disease area and prior clinical trial success in the population
  • National Co-ordinator recommendation of other national sites
  • A pre-tested, study-specific feasibility questionnaire sent with follow-up from the CRAs to ensure good-quality, reliable data including:

    • Availability of suitable patient population checked against their database or records
    • Anticipated rate of patient accrual
    • Resources
    • Inclusion of all other departments in the feasibility assessment (e.g. radiology, pharmacy)
    • Information on competing studies (in the population or for resources)
    • Ways to expedite contractual/budget negotiations

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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