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Allergy Case Study: Grass & Birch Allergy Phase II Parallel Studies

Case Study Description: 
Pharm-Olam was contracted to provide a full-service solution for two Phase II, dose escalation allergy studies that required a total of 500 patients in Europe and were run in parallel. With two different indications required, Grass Pollen Allergy and Birch Pollen Allergy, Pharm-Olam completed a comprehensive feasibility program and presented the findings to the sponsor for analysis and approval. 

Once approved, Pharm-Olam committed to recruit the required patients within 4 months, while adhering to strict inclusion and exclusion criteria.  Pharm-Olam completed enrollment ahead of schedule for both studies.  

Program / Studies Overview:
Two Phase II studies (1-Grass Pollen Allergy, 1-Birch Pollen Allergy)

Indication:
Grass Pollen Allergy and Birch Pollen Allergy 
(Allergic Rhinitis / Rhinoconjunctivitis)

Sites & Locations:
23 Sites distributed between Germany and Poland (Grass Pollen study)
21 sites in Czech Republic, Germany and Poland (Birch Pollen study) 

Pharm-Olam Services:

  • Feasibility & Site Solutions
  • Project Management
  • Clinical Operations & Trial Management
  • Data Management
  • Medical Affairs & Pharmacovigilance
  • Patient Engagement Services
  • Biostatistics
  • Medical Writing
  • Quality Assurance