Phase IV Monitored Trials

Phase IV monitored trials collect data to address issues that support product success in a real-world clinical practice. With our extensive Phase IIIb-IV experience, PPD designs and executes Phase IV monitored trials to accomplish the following post-approval objectives:

• Demonstrate superiority versus competitive products
• Attain approval of new indications or label changes
• Establish safety and efficacy in new patient populations
• Validate new dosing or models of administration
• Improve physician education regarding appropriate use
• Conduct safety surveillance for targeted endpoints

Effective Trial Management

Centralized systems and processes give PPD the ability to design simple but effective Phase IV monitored trials with experienced investigators. Dedicated project teams create comprehensive solutions specific to your requirements, including:

• Accelerated trial start-up
• Rapid investigator and patient recruitment
• Centralized patient enrollment and randomization
• Real-time client and site communications
• Analysis and reporting of clinical data
• Site management and targeted on-site visits
• Regulatory compliance
• Health economics and quality of life studies
• Managed care consulting from our health outcomes team

Whether PPD is working with just a few or with thousands of sites, our contact center infrastructure is designed to handle large volumes of data with optimum speed and efficiency:

• Interactive voice response systems
• Telephone monitoring
• Fax-based data collection
• Internet applications for data collection and distribution

Therapeutic Experience

We employ scientists with specific therapeutic expertise to optimize the design and implementation of your late stage projects. PPD’s Phase IV trial experience includes the following therapeutic areas:

• Anesthesia
• Cardiovascular
• Diabetes
• Erectile dysfunction
• Hypertension
• Migraine
• Obesity
• Osteoarthritis
• Prostate cancer
• Schizophrenia
• Sepsis