Clinical Phases

Metronomia, the right choice for early to late phase

At Metronomia, we offer services only when we are absolutely convinced that our contribution will be delivered according to the highest quality standards and required timelines. Having completed over 600+ clinical projects in many different therapeutic areas and clinical phases, we are experts of the field who can provide you with good advice and services that best meet your biometric and data management needs across the entire clinical development cycle.

Drug development life cycle / Metronomia Services

Planning

  • Statistical consulting

Pre- / Nonclinical support

  • Non-clinical statistics
  • Biological data processing
  • Non-clinical medial writing

Early phase

  • Protocol & study document development
  • Trial design & methodology consulting
  • Sample size calculation
  • Regulatory consultancy

Via our partner Network with Phase I units and expert pharmacologists

  • Phase I First-in-Human studies (Punkte untereinander, klappt bei mir nicht)
  • PK/PD and BA/BE studies
  • Food-drug and drug-drug interaction studies
  • Phase IIa / proof of concept studies

Phase II / III

Full range of

  • Clinical data management
  • Biostatistical services
  • Statistical pogramming
  • Medical writing
  • Pharmacovigilance

Phase IIIb Phase IV

  • Phase IIIb and IV randomised clinical trials
  • Observational / non-interventional studies and registries
  • PASS or PAES studies
  • Health economics and outcomes research
  • Competitive marketing claims studies

NIS

  • Post Marketing Surveillance (PMS) studies
  • Cross-sectional studies
  • Longitudinal studies

Medical Device studies

  • Clinical investigations to gain CE-marking
  • Clinical investigations with CE-marked products
  • Post-Market Clinical Follow-up (PMCF) studies
  • Surveys

Facts & Figures

20%Phase I 15%Phase II 20%Phase III 20%Phase IV 25%NIS

“When it comes to your projects, we act as an extension of your team. If you started a project elsewhere and require further assistance or consultancy, we would be glad to assist you. Don’t hesitate to reach out for our trial-rescue-service, which has successfully saved numerous studies!”

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