PPD® Functional Service Partnership (FSP) Clinical Data Management Solutions
End-to-End Clinical Data Management Solutions Safeguard Data Integrity
To safeguard data integrity and better equip study teams, we offer the technology, processes and expertise needed to deliver quality data across a broad range of therapeutic areas, electronic data capture (EDC) technologies, third-party vendors, Phase I-IV clinical trial services, and advanced data cleaning strategies through our end-to-end CDM solutions.
Our data managers are more than technologists; they’re data stewards, working to drive real-time data collection and management and consolidate disparate data sources. By combining clinical trial data from a single study or a collection of studies, at the compound or portfolio level or from external vendors, we significantly increase data transparency and the quality of decision making.
Customized Solutions and Staffing to Best Meet Your Needs
Flexible Models Delivered by Empowered Teams
We work directly with you to provide the best outsourcing model for your project, including a flexible mix of systems, processes, oversight and facilities. We can embed staff within your workforce or take the business fully in-house using PPD innovations and technologies. Our project teams are empowered with the flexibility to provide solutions that meet your unique needs and include a customized mix of roles.
A typical team may include a group lead (associate director/director) who oversees processes, timelines and contracts and ensures quality standards are met. A CDM project lead assigns resources, manages the budget and contract, and evaluates the project for risk management and contractual changes. A CDM team lead works with the CDM project lead to maintain responsibility for all project activities and deliverables. Multiple other staff roles, as needed, fill out the team.
Custom Technology to Streamline Operational Delivery
We also work closely with you to develop customized data collection technology and processing solutions to meet your operational delivery needs. Using either your standard operating procedures (SOPs) and systems or PPD SOPs, “real-time” interfaces and electronic patient reported outcomes (ePRO) technologies, we focus on improving the speed of data acquisition and review. We strictly adhere to operational and quality procedures to drive data integrity. Further, we bring broad experience with EDC systems, allowing us to work with your system of choice.
Dedicated Staff Undergo Specialized Training
Prior to commencing our partnership, our dedicated staff managers ensure that all assigned staff receive training on your specific SOPs, processes and technologies, study-specific training, and PPD internal corporate training. Our professional development and learning culture also help make the PPD clinical research business of Thermo Fisher Scientific a great company to work for, increasing CDM employee engagement and retention.