Megatrials

With nearly a decade of multitherapeutic experience in the conduct of large Phase IIIb-IV global clinical trials, PPD is a full-service provider of megatrial (more than 150 sites and/or more than 1,000 patients) services. From study design to final submission or report, we quickly and efficiently mobilize our global resources to conduct effective megatrials.

Our specialized clinical teams select and recruit both experienced and research-naïve investigative sites. Our processes, procedures and systems minimize the burden of research on participating physicians and patients.

To effectively conduct these trials, the PPD team provides:

• Proven effectiveness in the recruitment and management of research-naïve investigators
• Global regulatory experience
• Global reach, with local physicians and clinical research associates knowledgeable in local requirements, language and customs
• Multiple therapeutic expertise
• Large trial safety endpoint experience

Services Provided

In compliance with good clinical practice (GCP), International Conference on Harmonisation (ICH) and Office of the Inspector General (OIG), our services for the conduct of large global late phase programs include:

• Trial design and consultation for Phase IV monitored trials, as well as expanded access and large simple safety studies
• Investigator-initiated trial support
• Streamlined startup and maintenance
• Project management
• Site management
• Clinical monitoring (remote and targeted on-site)
• Robust technology platform with global capability, including interactive voice response system (IVRS), Oracle^® Clinical Remote Data Capture, PPD Global View and PPD Patient Profiles
• Health outcomes consultation and program design
• Data and safety monitoring board and clinical events committee coordination and oversight
• Quality auditing