SUCCESS STORY
Accuracy Research (AR) partnered with Chinese technology and genetic engineering firm Anhui Zhifei Longcom and medical services company Biomed during the Phase 3 clinical trial of the Zifivax vaccine for coronavirus.
This collaboration aimed to secure regulatory approval for the vaccine once the Phase 3 trial is successfully completed.
The study included over 28,000 participants and was conducted at 31 clinical centers in five countries.
Our team managed the study, oversaw operations and planning, and handled regulatory affairs, pharmacovigilance, and quality control. In Ecuador, three research centers recruited around 5,000 participants.
Accuracy Research played a key role in the development of the clinical study with the goal of improving people’s quality of life through accurate and reliable data.
We were involved in the following phases of the research:
🔹The clinical study’s preparation stage involved generating documentation and completing tasks such as modifying the protocol and CRF to meet regulatory and ethical requirements, selecting investigators, and ensuring that research centers had the necessary infrastructure and equipment. The goal was to ensure compliance with legal, audit, and GCP management requirements.
🔹During the clinical study, AR was responsible for managing the research centers and overseeing the recruitment of participants. We ensured that participants met the inclusion and exclusion criteria and gave informed consent, and that all study procedures outlined in the protocol were carried out correctly. AR also handled any issues that arose during the study, such as protocol deviations, adverse events, data management, as well as being responsible for managing and organizing the study documentation.
🔹In the final phase of the clinical study, AR confirmed that all necessary documents were completed, signed, and filed properly. In addition, we developed the statistical report and final results report, which may be used as the basis for publishing an article about the study.
Anhui Zhifei Longcom, Biopharmaceutical Co. Ltd. expressed their gratitude with the following words: “CRO Accuracy Research did a good job managing the clinical trial and received positive feedback from the sponsor. They provided expertise in logistics, regulatory affairs, clinical operations, and internal audits, and had effective communication with the sponsor. This helped them pass inspections by local and Chinese regulatory authorities.”
At Accuracy Research, our goal is to provide excellent service to our clients and prioritize the well-being of our patients throughout the research process.
We prioritize using the latest technology in biomedicine and biopharmaceuticals and embrace innovation in our research efforts.
🤝 Partnering for progress in clinical research 🤝
