Large Simple Safety Studies

Large simple safety studies are extensive epidemiological trials that establish the effectiveness and safety of drugs in use among broad patient populations. These studies can potentially incorporate thousands of sites and patients.

PPD’s dedicated late stage drug development team utilizes centralized processes and contact center technologies to meet the challenges of large simple safety studies:

• Recruitment of community-based prescribing physicians
• High patient enrollment targets
• Program design with minimal inconvenience for participating patients and physicians
• Real-world physician practice pattern outcomes
• Targeted collection of data and safety endpoints

Since 1999, we have recruited in excess of 100,000 subjects at more than 18,000 sites throughout the world.

Services

Our proven processes address the close regulation required by the FDA for these pre-approval studies while obtaining data in real-world settings. We provide cost-effective solutions in large simple safety studies, including:

• Comprehensive consultation
• Streamlined startup processes
• Regulatory compliance
• Scientific integrity
• Patient recruitment
• Patient experience follow-up tracking

We proactively communicate with research-naïve sites, ensuring that studies are implemented according to project requirements and timelines. With an understanding of the unique details of each project, PPD acts as a liaison with site physicians and:

• Communicates and answers questions proactively
• Clarifies and resolves queries
• Troubleshoots compliance issues
• Fills requests for additional supplies
• Reports adverse events
• Provides marketing support services