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

Medical Monitoring

Gaea can provide experienced Medical Monitoring for all clinical trials; our medical monitors have clinical experience of the therapeutic areas we cover, and experience as Medical Monitor in international clinical trials. Medical Monitoring includes:

  • Study document review (IB, protocol, CRF, ICF)
  • Therapy area training
  • Clinical development planning
  • Protocol and project-specific safety training at investigators meetings
  • Medical and Safety monitoring with 24/7 coverage
  • Project-specific medical monitoring manuals / safety monitoring manuals / safety reporting plans according to country-specific regulatory requirements
  • Handling medical queries from sites or ECs regarding appropriate interpretation and application of the study protocol, including advice on emergency management and dose titration
  • Assessing subject eligibility
  • Medical review of data listings
  • Review of medical coding data
  • Literature evaluations
  • Preparation of CTD Module II
  • Expedited reporting of SAEs
  • AE and SAE logging, tracking, MedDRA and WHO-DD coding, case processing and distribution to stakeholders
  • Individual case safety reports
  • Aggregate report writing
  • Periodic safety updates
  • Development safety update reports
  • Concise safety analysis and benefit-risk evaluation
  • Annual safety reports or clinical safety reports
  • Risk evaluation and mitigation strategies

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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