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Belfast - Center of Excellence for Respiratory

Celerion

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      • Development of an LC-MS/MS Peptide Method
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      • 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
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  • Spring 2013 Newsletter
  • Fall 2012 Newsletter
  • Spring 2012 Newsletter

Difficult to Recruit Population

Global Processes
Data Management
Recruiting

Need
  • Required a study targeting a difficult to recruit therapeutic patient group
Approach
  • Developed a creative strategy to split recruiting and dosing of this study at Celerion clinics in two geographical locations
  • Multi site approach enabled on-time recruitment for this niche patient group
  • Executed clinical conduct almost in parallel using identical processes, enabled by global processes employed by Celerion
  • Required only one Case Report Form (CRF) template and Data Management Plan
  • Conducted Data Management activities from two different locations on one centralized server using the same process flows while adhering to global Standard Operating Procedures (SOPs)
Benefits
  • Creative use of recruiting and dosing at multi sites enabled Celerion to deliver a database within the clients’s timeline expectations