Our company initiated a large global oncology clinical trial in 2006 with another global
CRO (ie not Pharm-Olam). 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 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 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 Pharm-Olam
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.
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.
I have worked with many large and small CROs over the years and would highly recommend Pharm-Olam for any project of any complexity.
Regards,
Chief Operating Officer and VP of Clinical Operations
Community Acquired Pneumonia Rescue
To Whom It May Concern:
It is with great pleasure that I recommend Pharm-Olam International based on the excellent services provided for our recent Community Acquired Pneumonia study.
This challenging study was conducted in over 25 countries (North America, Latin America, Europe, Asia, and South Africa) at close to 200 investigator sites. Pharm-Olam was responsible for the global management of the study as well as monitoring in USA, South Africa, and Europe.
The global management responsibilities included reporting to sponsor, review and approval of all regulatory packages, global medical monitoring, global project-related training, and management of all vendors including 5 regional CROs.
At the conclusion of the study a total of 617 patients were recruited, of which Pharm-Olam recruited 231 patients, exceeding the original target of 149 patients.
Turnaround timelines for actions were consistently achieved and POI's constant communication with the global teams and Vendors resulted in a smooth execution of study and on-site activities. I would look forward with working with Pharm-Olam in the future and I would recommend this company for future work.
Associate Director, Clinical Outsourcing
Breast Cancer Phase II
Drug Safety Surveillance Development Department
Dear Sir/Madam:
I would like to act as a referee on behalf of Pharm-Olam International (POI). Our group became acquainted with POI and subsequently,
following a competitive bid review, they were selected as the CRO monitor for our Phase II breast cancer oncology study in Poland.
This study was already up and running at 4 investigator sites in the United Kingdom and was being monitored there by an Independent
Project Manager. It became necessary to set up additional sites in Poland because the UK sites had tried unsuccessfully to complete patient enrolment for this study.
The study timelines for our Phase II Breast Cancer Study were quite aggressive because of the ongoing snail pace enrolment at the UK sites. From study set-up to initiation of the Polish sites, POI was either ahead of the timelines or right on it. I would honestly say that the POI-Polish team was very highly coordinated, and handled all study set-up activities, including investigator site selection and study registration with the Polish Regulatory Authority rather expediently. I was especially impressed with the project management skills of the regional POI-Poland Study Project Manager - she was excellent. Routine study related updates were very timely, and the average response time to our requests was between 24 and 48 hours without correcting for the 8-hour time difference between our location and theirs. Serious adverse events were forwarded to us within 24 hours of occurrence and our request for follow-up information was always handled expediently. The study CRAs were well trained and highly professional.
Prior to contracting the services of POI and setting up the Polish sites, we had fallen significantly behind our timelines for the Phase II Breast Cancer Oncology study. With POI's effort we were able to complete submission of regulatory documents, obtain regulatory and all Ethics Committees' approval for study start, set up and initiate all Polish sites within 3 months. Patient Recruitment started the week after our company and POI initiated the investigator sites, and was completed within 4 months from that time. This significantly offset the effect that slow recruitment at UK sites had overall on the study timelines.
Personally, I would use POI again, and would not hesitate to recommend them to other clients.
Sincerely,
Clinical Operations Director
Pediatric Asthma Rescue
To Whom It May Concern:
It is without reservation that I offer my highest recommendation for Pharm-Olam International (POI). We performed a U.S. registration trial in pediatric patients with mild/moderate/severe asthma from in Poland using POI. The selection of POI was necessary due to the inability of other CROs to complete enrollment in a timely manner. I would just like to share with you some of the many highlights of working with POI:
The Study Management and Execution: The challenges faced in conducting this trial included highly compressed timelines for team assembly, site selection, regulatory document collection and study start-up activities. All timelines either met or exceeded our expectations.
The POI Staff: The POI staff demonstrated a thorough understanding of the protocol and the skills necessary to execute this trial with quality. The POI team members were a pleasure to work with and demonstrated an excellent attitude towards their work.
The Recruitment: The recruitment challenges were considerable based on the required age and inclusion/exclusion criteria of participants. In order to obtain the necessary number of patients, we asked POI to basically double their enrollment numbers half way through the trial and still meet the original timelines. The team successfully met this challenge.
The Data Quality: I was very impressed by the overall quality of the data from Poland. This trial was run in a number of other countries by other CROs. POI has the lowest number of data queries per site out of all countries and CROs. They also had the shortest query retrieval and resolution time compared with their counterparts.
I look very much forward to working with the POI team again on future projects.
Regards,
Manager, Respiratory Medicine
Pediatric Allergic Rhinitis Rescue
Reference for Pharm-Olam International
To whom it may concern:
Upon request we accept to act as a referee on behalf of Pharm-Olam International (POI). We performed a seasonal allergic rhinitis study in paediatric subjects aged 6 - 11 years from May to September in Poland, using POI.
We requested the services of POI to conduct this study in Poland. By the end of the study Poland was the highest recruiter with 264 randomized patients. In fact out of all the 15 countries participating in the study POI recruited almost 30% of all patients. The patient data collected from POI sites was of high quality with less than 2 queries per randomised patient.
The recruitment was made respecting the set timelines at an appropriate speed. The team at POI, and their standards were well adapted to our working relationship. Communication between POI and our company was good. POI is showing good reactivity to emitted requests.
The work performed by POI was kept within the study budget. POI's experience with Ethics Committees/Health Board was helpful in the obtention of agreements from EC's. In conclusion, Pharm-Olam International gave us entire satisfaction.
Clinical Manager and Study Manager
Lung Cancer Quality Control Rescue
Reference for Pharm-Olam International
To whom it may concern,
I would like to act as a referee on behalf of Pharm-Olam International (POI).
Our company performed a Quality Control (QC) project for a phase III clinical study in lung cancer using POI, across European and Latin American countries.
The QC project began August with training meetings for the monitors, and the visits began in
September and continued to December, with a view to extending into the next year for Latin American sites still to enroll. POI covered 14 out of 18 countries participating, completing over 115 visits.
POI carried out the visits and provided the written visit reports in a timely manner and as per our directives. The visits were performed within the planned timelines, and any extended timelines were due to the recruitment status of the sites.
The POI contacts were very professional, supportive of our requirements, showed flexibility when necessary for the project, and have been a real pleasure to work with.
I would be very happy to work with them again in the future, and provide my full recommendation.
