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Our Experience

Clinical Trials experience

Our reputation is based on experience and expertise in First-in-Human, Oncology and complex Early Phase studies.

  • First-in-Human (FIH)
  • Food Interaction
  • Single Ascending Dose (SAD)
  • Multiple Ascending Dose (MAD)
  • Proof Of Concept
  • TQTc Monitoring
  • Vaccines
  • Bioequivalence/Bioavailability
  • Biosimilars
  • Cytochrome P450 Genotype Metabolism
  • Drug Interaction
  • Ethno-Pharmacology
  • Immuno-Oncology

 

Pharmacokinetic and Pharmacodynamics experience

Our extensive Pharmacokinetic and Pharmacodynamics studies span:

  • Early stage vaccine trials (including GMOs)
  • Adaptive clinical trial designs (health volunteers and patient cohorts)

Clinical Trials and vendor audit experience

Our independent audit performance history spans over 100 sponsor audits.

We have hosted multiple positive regulatory inspections by international authorities, including:

  • Three U.S. Federal Drug Authority (FDA) regulatory inspections in 2017, 2012 and 2008
  • European Medicines Agency (EMA) regulatory inspection in 2017
  • Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) in 2012
  • Hosted more than 100 research-sponsor audits.

Our quality assurance team conducts ongoing audits of all vendors to ensure compliance to high standards. Learn more about our quality standards.

 

Learn more about conducting Clinical Trials with Nucleus Network

 

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