Critical Care Studies

Expedite drug development in an intensive care setting with PPD's comprehensive services. We understand the unique nature of clinical studies in a critical care environment and ensure the quality of your development program with:

• Extensive experience in critical care settings
• A global network of investigators experienced in clinical trials in a critical care setting
• Hundreds of qualified investigative sites in more than 25 countries
• Timely study enrollment
• Expertise in simultaneous multinational submissions
• Technology solutions to manage efficacy and safety data

We conducted or supported 65 protocols in critical care indications involving approximately 8,600 patients and 1,300 sites between January 2004 and July 2009.¹

Critical Care Study Challenges

PPD’s dedicated critical care team works closely with you to meet the special challenges of this type of study:

• Our country-specific knowledge enables us to start treatment within the timeframe specified in the study protocol, allowing the study drug to be administered within hours of a precipitating event.
• Understanding the expectations of local institutional review boards (IRBs) or independent ethics committees (IECs) enables PPD to assist investigative sites in preparing submission packets that result in immediate approval.
• PPD’s dedicated startup group helps prevent delays in document collection, contract negotiations and site calls.
• By understanding the elements essential to trials involving multiple departments, such as emergency rooms, intensive care units, radiology units and blood banks, PPD is able to evaluate and select the most qualified sites for critical care trials, targeting sites that have established inter-departmental relationships. PPD also works with these sites to establish well-scripted, trial-specific plans that address all involved departments.
• The PPD clinical team collaborates with the investigative site to create a site-specific recruitment strategy (SSRS) before any patients are enrolled in the study.

Our clinically trained teams with therapeutic expertise in critical care trials ensure effective trial development and design.

¹ These numbers don’t include our work in the nontraditional services sector, which is managed separately.