PROGENITOR INTERNATIONAL RESEARCH: VACCINE EXPERTS IN THE EMERGING MARKETS
Progenitor International Research is an Emerging Market CRO with focused vaccine experience. In the last 18 months we have been awarded over 14 vaccine trials in China, South Africa, and Latin America. Some key differentiators of Progenitor include:
90% of our team in Latin America has vaccine experience. We are currently running a Phase III study with 24,000 pediatric subjects in Argentina and Panama
Vaccine focused team in China with experience in over 9 studies, and key relationships with the best-in-class ICH GCP experienced research sites
South African team with experience in Namibia and Kenya in training and developing sites for vaccine research
CASE STUDY OF THE YEAR 2007-2008: 24,000 PEDIATRIC SUBJECT PHASE III TRIAL
IN LATIN AMERICA
Progenitor countries include Argentina and Panama: Over 150 sites
Sponsor is a Top 5 Pharma Company
Study for EMEA submission
We have had 7 Argentina regulatory inspections to date,
with no major findings related to our services
Challenges
Progenitor Solutions
Pediatric trial with high scrutiny by regulatory authorities.
Risk of budget inflation due to travel time.
Relocation of staff next to the sites in order to organize constant monitoring of three/four days per week for the trial duration.
Sponsor selected the sites: many with no prior ICH-GCP experience.
Training at each monitoring visit on logistics, protocol, GCP
One year critical timeline.
Ongoing support of local staff for recruitment and follow up
Complicated logistics: Surveillance sites to capture SAE's Distribution of vaccine and cold chain aspects which is it a separate site than the vaccination sites Biological sample logistics
Organized as full responsibility of dedicated FTE's: SAE specialist in charge of tracking Vaccine specialists Biological sample specialists
Risk of budget inflation due to time on site: Over one million CRF/RDE modules
Regular review of monitoring performance using specific drivers
VACCINE CLINICAL TRIALS ARE CHALLENGING
Vaccine trials provide a unique challenge and demand an experienced team. With a large number of subjects, long-term follow-up periods, specific logistical requirements, at-risk patient populations and the demand for quality research sites, trust your trial to a CRO with a track record of vaccine development success.
At Progenitor we understand these challenges and have successfully delivered solutions to our customers to meet their expectations in terms of quality, time and costs.
