We offer the range of services required for clinical studies performing all kind of PK trials with various routes of administration in healthy young and elderly subjects and in some ambulatory patient populations. We are highly specialised in matching the demands of our client and of the regulatory environment. All services are under one roof so that the single parts of the development steps can be coordinated in an optimal way.

Our full service packet contains:

  • Early clinical development consulting
  • Protocol development
  • Protocol writing
  • CRF designs
  • Medical writing
  • Project management      
  • Recruitment
  • Complete conduct of  the study
  • Pharmacy
  • Statistics and reporting
  • Data management
  • Data analysis
  • Biometrics (Statistical consulting
    and analysis plans, PK analysis,
    statistical evaluation etc.)
  • Quality control and management
  • Quality assurance
  • Archiving
  • Documentation and reporting in
    compliance with current ICH/GCP guidelines

Special assessments include for example PET, EEG, BAL, DEXA Scan, environmental exposure chamber, capsule endoscope, molar extraction, polysomnography/sleep, neuropsychometric tests and ratings scales, controlled drugs testing, (male) fertility and hormone replacement (female), exposure studies/smoker studies.

 

Momentum Pharma Services Photos
Momentum Pharma Services Photos