Gaea | Clinical Ltd
One Broadcarr Road
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

Study start-up

An important aim for fast site start-up is to show sites that the sponsor is effective. A global study will gain early momentum from a significant number of sites being activated quickly. 'First patient in' should no longer be a valid metric, the goal must be 'last patient out' or database lock.

Trials in Europe often start more slowly than in North America. This is often blamed on an intrinsically complicated regulatory process and bureaucratic contract procedures, but there are some solutions to this including:

  • Effective planning
  • Parallel activities with site regulatory and site contracts
  • Experienced, motivated CRAs and an effective clinical team (not reliant on the minimal 'start-up team' that large CROs often use in the interim while they look for resources)
  • Emphasis on sites getting involved in pre-screening of patients in the period between evaluation and site initiation

In our experience, many CROs perform activities in series as opposed to in parallel as they struggle to find enough internal resources for a new project. We are a small, committed CRO and so do not take on work that we cannot deliver - our established and motivated team is a major factor in our success in site start-up and the overall management of a trial.

Submissions to the central and local authorities require a deep understanding of the EU Clinical Trials Directive, country-specific requirements and ICH-GCP. Gaea can help you with:

  • Understanding Annex II processes for the submission of amendments, annual reports and safety updates in some European countries
  • Preparing responses to any questions raised by the authorities within the appropriate timelines
  • Submissions to additional authorities, e.g. radiation board, data protection board, R&D
  • Management and quality check of all essential documents required for IMP release according to the client's/our checklist
  • Insurance cover
  • Site-level contract and budget negotiations
  • Vendor agreements (e.g. central radiology, IWRS, EDC)
  • Input into selection of central systems
  • Reviewing vendor bids through to execution with on-going vendor management and monitoring of vendor performance

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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