About the Case Study
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.
Sites & Locations:
23 Sites distributed between Germany and Poland (Grass Pollen study)
21 sites in Czech Republic, Germany and Poland (Birch Pollen study)
Services Provided:
- Feasibility & Site Solutions
- Project Management
- Clinical Operations & Trial Management
- Data Management
- Medical Affairs & Pharmacovigilance
- Patient Engagement Services
- Biostatistics
- Medical Writing
- Quality Assurance
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