| 723 Breast Cancer Patients Pharm-Olam completed enrollment of a 723 anthracycline-naïve patient pivotal trial for the treatment of metastatic and recurrent breast cancer. Enrollment of the Phase III clinical trial was achieved six months ahead of schedule and included 103 clinical sites in 17 countries around the world.
- First-Patient-In was on time
- Last-Patient-In was on time
- Regulatory and EC approvals were on time
Top recruiting countries: Russia (226), India (176), Ukraine (97), Georgia (36), Poland (32)
Our sponsor was provided full services, including: Site Selection, Monitoring, Investigator Meetings, Ethics and Regulatory Approvals, Import/Export Licenses, Drug Labeling and Distribution, Project Management, Pharmacovigilance, Data Management, Report Writing, Translations, and CRF Design and Printing.
Head and Neck Cancer Rescue (Sponsor Reference)
Our company initiated a large global oncology clinical trial in 2006 with another global CRO (ie not POI). Recruitment was an ongoing challenge and by the end of 2006 we had only recruited a fraction of the patients expected to be enrolled by that time, and were having serious issues with the CRO working for us in Eastern Europe.
We originally brought on POI to provide a ‘rescue’ service for us in Eastern Europe to replace the CRO being utilized in those countries. The POI project manager was one of the best I have ever worked with in 20 years of trials. She, and the POI project team, orchestrated the rescue and made a difficult transition go very smoothly without any significant impact on the study operations and completed this within a short period of time.
We were so impressed with the quality, efficiency and professionalism of this group in Eastern Europe, that we decided to also bring POI on board to cover India. Again, we were provided with a project manger of excellent quality who got the sites selected and up and running within a couple of months.
POI surpassed recruitment expectations within the countries they managed for us. They were easy to work with, flexible in meeting our reporting requirements and worked closely with the sites to ensure recruitment goals were met, patient care and the quality of the data being collected was excellent. We then utilized POI for a phase I dose-escalation study in 3 countries in Eastern Europe and had the same positive experience working with that team as we did our global trial.
I have worked with many large and small CROs over the years and would highly recommend POI for any project of any complexity.
Regards,
Chief Operating Officer and VP of Clinical Operations
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