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Breast Cancer

Pharm-Olam completed enrollment of a pivotal 723 anthracycline-naive patient Phase III clinical trial for metastatic breast cancer with 103 sites in 17 countries.

Further study details include:

  • Pharm-Olam managing sites across the Americas, CEE, India, and South Africa
  • Ensuring that the first patient in and last patient in were on-time
  • Delivering Regulatory and EC approvals on time
  • Pharm-Olam provided the following services: Site Selection, Monitoring, Regulatory, Pharmacovigilance, Data Management, and DSMB services
  • The original patient target was 540; which the sponsor later increased to 700 patients, and Pharm-Olam randomized 23 additional patients with sponsor approval for total of 723
  • The top recruiting countries included: Russia (226), India (176), Ukraine (97), Georgia (36), and Poland (32)
  • The average recruitment per site was 8.7 Patients

“The senior management team was responsive and concerned about the quality of service throughout the project. They were available at all times and immediately solved any challenges with the study or our requirements as a public company. We found the data quality and adherence to the protocol outstanding. Our compliments to Pharm-Olam and each of the Project Managers for the expertise they displayed throughout the study.” - Executive Vice President