The delivery of our customers’ patient data to support protocol requirements with high quality and data integrity is our complete focus. We strongly adhere to the requirements within ICH E6 R2 and collaborate across the project team to identify the critical risks to data delivery in a study, design data capture systems to drive real-time data collection and implement processes to minimize errors from being introduced in the data collection process. We ensure that data validations are in place for all patient data sources and coordinate the delivery of data from internal and external sources to support interim and final data deliveries.
Our clinical data management group offers global solutions with flexible models including full-service, select services, hybrid brick and mortar + mega site services or functional service provider (FSP) partnerships spanning all time zones allowing for 24-hour coverage. We deliver clinical data management services in several widely accepted electronic data capture (EDC) environments with interfaces to virtual technology, core laboratory, imaging and other ancillary systems. Our goal is to provide our customers with speed and accuracy of data acquisition to improve data quality, transparency and review, and to minimize timeline risks.
PPD’s clinical data management team approaches every study and customer as a relationship, first and foremost. While we have standard CDISC compliant standards in place, our clinical data management teams develop a strategic and holistic approach to each study, anchoring our perspective in the broader development goals of the companies we support. From this foundation, execution at the project level is consistent, urgent and effective.