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PPD® Functional Service Partnership (FSP) Clinical Data Management Solutions

The Solutions You Need to Make Faster and Smarter Decisions and Meet Your Timelines

As the volume of data collected in clinical trials continues to increase and the industry moves toward more complex trial designs and patient-centric approaches, efficiently consolidating, validating and reviewing disparate data sources with speed and transparency is critical.

PPD FSP Clinical Data Management solutions help biopharmaceutical, biotech and medical device organizations safeguard the integrity of their clinical trial data by delivering comprehensive clinical data management (CDM) solutions with much-needed resource flexibility, reliability and continuity.

Backed by more than 25 years of experience, our end-to-end CDM solutions and flexible delivery models provide the technology, processes and expertise needed to quickly deliver quality data, empowering study teams to make faster and smarter decisions and meet critical milestones.

Empower study teams to make faster and smarter decisions to meet your timelines.

Our Clinical Data Management Expertise,
by the Numbers

Zero Quality Concerns

0% of databases unfrozen due to quality concerns in the past year

1,000+ Studies

CDISC Platinum members have delivered 1,000+ studies and 350+ submissions in CDISC format

100% Production

100% of databases in production prior to first patient in when within PPD control

1,200+ CDM Employees

More than 1,200 CDM employees located in over 30 countries (including the United States and United Kingdom) and five continents, with ongoing recruiting in additional countries

1,500+ Studies Supported

Over 1,500 studies supported across the
most used EDC systems including:
• Rave EDC (Medidata) • Oracle Clinical • InForm EDC (Eclipse™)
• TrialMaster (OmniComm) • Vault EDC (Veeva)

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.

Comprehensive Solutions Encompassing the Full Data Life Cycle

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Strategy and Setup

  • Data strategy consulting
  • Database design, build and testing
  • Electronic case report form (eCRF) design
  • Clinical Data Interchange Standards Consortium (CDISC) study data tabulation model (SDTM) mapping and consolidation
Execution

  • Project management
  • Medical coding
  • Data validation and query resolution
  • Integration of data from eCOA, IRT, Lab Data, eConsent, Clinician Reported Outcomes (ClinRo), Electronic Device Reported Outcome (eDRO), eSource, wearables (e.g., apps, watches, monitors, patches), etc.
  • Management and reconciliation of third-party data
  • Management of local laboratory data
Technology

  • Expertise deploying, validating, testing and training for most used EDC systems
  • Provide clinical data management, technical, team and site-level training
  • Preclarus, our proprietary data and analytics platform, brings real-time access to study and lab data through data visualization dashboards and interactive reporting

Global Delivery Coupled with Local Control

Having support across local regions and around the globe is critical. Our resourcing approach provides specific support for regional, country and global deliverables.

To optimize communications and interactions, our employees span all time zones across the globe, providing 24-hour seamless coverage between on-site and virtual teams. This allows us to place our client-facing roles in the same time zones as your functional and clinical teams, enabling the combined team to become a unified, dedicated group integrated within your data management function.

Through our proven approach, we collectively create successful teams, encourage knowledge sharing and produce positive, productive interactions throughout the duration of our partnership.

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.

Contact Us

Ready to make faster and smarter decisions to meet your timelines? Connect with PPD FSP Clinical Data Management solutions for customized approaches that enhance speed and transparency, while maintaining data integrity and quality.