CRO completed startup and enrollment of Phase II study in less than three months
Health Decisions has completed enrollment for a Phase II universal flu vaccine study only three weeks after the first site initiation visit and less than three months after the partnership was contracted. If the candidate is proven effective, millions of flu vaccine doses could be produced in a time frame of weeks instead of months, a breakthrough with major positive implications for global populations threatened by seasonal and pandemic influenza strains like the H1N1 Swine Flu.
The candidate is produced through a proprietary process using a new, versatile growth environment that promotes faster maturation than chicken eggs—the standard environment since 1943. The Phase II study administers the candidate in conjunction with the standard flu vaccine to assess safety, immunogenicity and antibody response.
The vaccine’s developers chose to partner with Health Decisions for the CRO’s ability to meet two critical requirements that were vital to the study’s early success. First, all subjects had to be administered doses before the standard flu vaccine, to which the candidate was being compared, reached its expiration date. Missing this deadline would have meant losing months of progress waiting for a new batch to become available. In addition, reactogenicity data had to be captured, verified and made accessible to the sponsor immediately in order to closely monitor patients’ tolerability levels.
Health Decisions’ Agile Clinical Development platform provided a seamless solution to the trial’s complex challenges. The SmartPen advanced electronic data capture (EDC) system enabled investigator personnel to effortlessly capture data and automatically transmit it to Health Decisions for rapid, accurate analysis. Through Health Decisions’ rapid reporting system, the sponsor could access the data within 24 hours of the patient visit, which was key to making informed decisions about the trial’s progress, ensuring meticulous adherence to protocol, and minimizing risk to patients. Simultaneously, the system tracked sites’ enrollment performance in real-time, making it easy to keep the deadline in check.
For more information, contact Courtney Cleaves, Marketing Manager at email@example.com.
“The sponsor’s tight schedule and safety monitoring requirements presented a great opportunity for us to prove the capabilities of our Agile Clinical Development platform. We’re proud to support such an important medical breakthrough, and look forward to a bright future working with the sponsor to make vaccines more accessible to patients.”
Associate Director of Clinical Affairs