To be successful, a trial must be designed to withstand unexpected factors and handle them effectively. With over 20+ years of experience managing international trials, we have demonstrated the ability to produce results. WorldCare is a leader in the understanding of requirements for imaging trials and has recently published reviews on how to incorporate current FDA guidelines into imaging trials.
Trial start-up activities require the same attention to detail and focus as the rest of the trial. Early planning efforts during this early stage pay off later during the trial maintenance phase. Key elements to a successful start include understanding regulatory requirements, defining trial goals, and ensuring that the data collected and analysis process are aligned with those goals.
Expert subspecialty review, reader training and testing, and strict quality control (QC) of collected images come together under WCC’s total project management expertise. Our focus on regulatory preparation means all trial maintenance activities are performed within a proven workflow ensuring exceptional quality, consistency and regulatory compliance.
The quality of the evaluation results depends on strict and sophisticated expert reviewer training and continued variability monitoring to ensure performance. Our in-depth reader training, testing and ongoing performance monitoring are designed within this framework to maximize precision and accuracy.
At study closeout, WCC provides full regulatory consulting and assistance accompanied by image archival services that allow for central review or simple post-trial storage. This ensures all data is stored safely and securely for FDA submission, whether directly following your trial or any time in the future. Regardless of your trial needs, we enable you to maintain control throughout the entire process.