A sponsor conducting a large global study in 15 countries for Head and Neck cancer and had enrollment and other challenges with a CRO (a major global company) that was providing coverage in Eastern Europe. This CRO was working with 17 sites in Russia and the Ukraine which had enrolled only 21 patients after several months of recruitment. The sponsor selected Pharm-Olam to begin taking over the existing sites in Ukraine and Russia and handle regulatory submission to initiate new sites in Serbia, Croatia, and Slovakia. Pharm-Olam provided a fast, smooth transition for the existing sites and was able to achieve enrollment objectives.
Impressed by our quality and enrollment performance in Europe, the sponsor decided to let Pharm-Olam competitively enroll patients in India, which also met their expectations. The study met its enrollment objectives, with Pharm-Olam recruiting the majority of the patients.
“We brought on Pharm-Olam to provide a ‘rescue’ service for us in Eastern Europe to replace the CRO being utilized in those countries. The Pharm-Olam project manager was one of the best I have ever worked with in 20 years of trials. She, and the Pharm-Olam project team, orchestrated the rescue and made a difficult transition go very smoothly. We were so impressed with the quality, efficiency and professionalism of this group in Eastern Europe, that we decided to also bring Pharm-Olam on board to cover India. Again, we were provided with a project manager of excellent quality who got the sites selected and up and running within a couple of months.
Pharm-Olam 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 Pharm-Olam 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.” - Chief Operating Officer and Vice President of Clinical Operations