• Celerion Newsletter
Belfast - Center of Excellence for Respiratory

Celerion

committed to service excellence

Primary Navigation for Celerion

  • Home
  • About Celerion
    • Why Celerion?
    • Mission, Vision and Credo
    • Management Team
    • Who We Work With
    • Locations
    • Environmental Sustainability
  • Applied Translational Medicine
    • Key Elements of Success
  • Services
    • Global Clinical Research
      • AAHRPP Accreditation
      • Phase I and lla Studies
      • In-hospital Beds
      • Study Experience
      • Belfast – Center of Excellence for Respiratory
      • Early Cardiac Services
      • Hybrid Phase I/ECG Core Lab
      • ADME/Mass Balance
      • Microtracer Studies
      • USP <797> Clean Room
      • ClinQuick® Electronic Data Acquisition
      • Recruitment
    • Clinical Pharmacology Sciences
      • Modeling and Simulation
      • Study Design and Protocol Development
      • Data Programming
      • Biostatistics
      • Pharmacokinetics/Pharmacodynamics (PK/PD)
      • Medical Writing and Reporting
      • Streamlined Data Flow Process
    • Global Bioanalytical Services
      • Small Molecule
      • Large Molecule
      • Electronic Laboratory Notebook System
      • ADME/Mass Balance
    • Drug Development Services
      • Biopharmaceutical Development
      • Program and Project Management
      • Regulatory Affairs
  • Celerion Europe
    • Global Clinical Research
    • Clinical Pharmacology Sciences
    • Global Bioanalytical Services
    • Management Team
  • The Biosimilars Alliance
    • The Biosimilars Alliance – Overview
    • The Biosimilars Alliance – Benefits
  • Case Studies
    • Global Clinical Research
      • Responding to an Unexpectedly High Drop Rate
      • Mass Balance Study
      • Semen Clinical Trials
    • Clinical Pharmacology Sciences
      • Partnering with Biotechnology Companies
      • Partnering with Large Pharmaceutical Companies
      • Protocol Study Design and Development for Generic Studies
      • Difficult to Recruit Population
      • Consistent Database Structure for Programs of Studies
    • Global Bioanalytical Services
      • Improved Desmopressin Analysis of Clinical Samples
      • Optimized LC-MS/MS Method for New Observed Metabolite
      • Bioanalytical Support of Oncology Studies
      • High Throughput Bioanalytical Analysis
      • Partnering with Biotechnology Companies
      • Partnering with Pharmaceutical Companies
      • Development of an LC-MS/MS Peptide Method
    • Drug Development Services
      • Support of CMC to IND for Novel First-in-Class Small Molecule Drugs
      • Rapid Proof-of-Concept for Novel Drug Treatment for Rare Metabolic Disease
      • Proof-of-Concept Efficacy Clinical Study
      • European Biotechnology Company Seeking First-in-Human U.S. Clinical Study
      • Asian Biotechnology Company with CNS Compound
  • White Papers
  • Other Resources
  • News & Events
    • Press Room
    • Conferences
    • Symposia
    • Webinars
  • Participate in a Study
  • Careers
    • Message from the CEO
    • Culture
  • Spring 2013 Newsletter
  • Fall 2012 Newsletter
  • Spring 2012 Newsletter

Services

Global Clinical Research

Partnering with Celerion means working with one of the most experienced CROs in the world.

With over 40 years of experience, more than 750 beds in North America and Europe, Celerion offers the largest global Phase I and IIa clinical operations networks in the industry.

Celerion is a market leader in Early Cardiac Services, having completed over 40 TQT and more than 100 robust QT studies. In 2010 Celerion launched the first Hybrid Phase I/ECG Core lab in the market. Integrating the ECG functions within Celerion’s Phase I clinic network, minimizing traditional ECG overhead and providing more automation, has enabled fast access to data and cost-effective solutions that deliver high-quality data for the execution of thorough QT studies and ECG assessment in SAD and MAD programs.

In 2011 Celerion launched the addition of a USP Clean Room to enable efficient execution of microtracer and microdosing studies. The USP Clean Room also allows for all types of complex extemporaneous compounding for low, medium and high risk investigational compounds. Clients benefit by accessing quality data earlier in drug development process.

Celerion's clinical site in Lincoln, Nebraska is licensed to conduct studies with radiolabeled compounds. In the last 10 years, the clinical team in Lincoln, Nebraska has conducted more than 40 radiolabeled clinical trials, dosing nearly 300 participants, successfully recruiting healthy normal males, females and elderly subjects.

The company's breadth of capabilities coupled with purpose built facilities (co-located Pharmacy, clinical laboratories and flexible conduct areas) ensure the quality data is delivered on time.

Phase I and IIa Services:

  • ACLS Certified Nursing Staff
  • Analytical laboratory
  • Archiving
  • Dedicated IRB
  • Electronic Case Report Form (CRF)
  • Electronic data capture
  • On-site clinical laboratory
  • On-site pharmacy with licensed pharmacists
  • Oracle / SAS programming
  • Project management
  • Quality control
  • Quality assurance
  • Recruitment / outreach

Global Clinical Research offers clinical conduct with centralized 24-hour scheduling, rapid recruitment and thought leadership that includes broad therapeutic area expertise.

See also...

Press Release: Celerion is the First CRO Headquartered in the USA to Receive Full Accreditation from AAHRPP

Press Release: Celerion receives ANVISA Certification

Press Release: Celerion recognized as member of the UK Respiratory Therapeutic Capability Cluster

For more information contact us

Footer Naviation

  • About
  • Locations
  • Careers
  • Request a Proposal
  • Contact
  • Privacy Policy
© 2013 Celerion