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

Pharmacovigilance

Through our established 24/7 electronic reporting line, Gaea can manage SAEs across global clinical trials. In combination with our pharmacovigilance team and Medical Monitor we can provide all pharmacovigilance services in accordance with ICH-GCP and national regulations

Pharmacovigilance Team

  • Drug Safety Project Management
  • Collection and follow-up of Serious Adverse Events (SAEs) from clinical trials
  • Electronic management of SAEs on our database
  • Expedited reporting to Competent Authorities
  • Expedited reporting to Ethics Committees and Investigator sites
  • Six monthly and quarterly reporting to Competent Authorities and Ethics Committees
  • Responsible Person for Eudravigilance oversight
  • Reconciliation with clinical database
  • Compliance review and oversight
  • Eudravigilance set up and management
  • Signal Detection
  • 24 hour cover
  • Filing and Archiving


Medical Monitor

  • 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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