Regulatory Standards Project Management Data Entry Patient Assessments ICH GCP Certification
Sample size increased from 500 to 650 volunteers.
AZ Sint-Maarten was partnering with a large pharmaceutical organization to conduct a clinical trial for a potential COVID-19 vaccine. However, due to the sheer volume of volunteers the hospital was taking on — a total of 500 — they quickly realized they would need more staff to assist with processing the volunteers and maintain an organized, effective trial. Each day, 65 volunteers needed to be processed, added to the system, and assisted with installing a mobile app to monitor their symptoms. In addition, the client was faced with a constantly shifting political environment — amendments were being made regularly, and they had to be sure they were upholding the right regulatory standards. The individuals they brought on to help had to be flexible, familiar with regulations, experienced with data entry and clinical trials, and maintain an ICH GCP certification along with a nursing degree.
Oxford Global Resources was contacted to provide the nurses required to meet the client’s needs. Because of the thorough collaboration and the hands-on experience we had supporting similar sites, AZ Sint-Maarten chose us to support them. Within a week, we were able to provide the nurses they needed and help ensure the clinical trial ran smoothly. During the installation of the electronic diary, there was a malfunction with the system, so we were able to provide additional support to help install and manage the system.
Throughout the project, we ensured that we could provide a flexible and adaptable support model so that coordination and planning could be a collaborative process between ourselves and the client.
Because the team was functioning so well, AZ Sint-Maarten was able to ramp up the sample size from 500 to 650 volunteers – leading to more thorough data collection and potentially better results from the trial overall. During the course of the trial, the hospital received a sponsor inspection, during which only one minor finding was discovered. We have continued to support them through the duration of the clinical trial.