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

Meeting the Challenge of Critical Care Studies

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

Investigative sites are often tertiary care university-affiliated centers that require local Institutional Review Board (IRB) or Independent Ethics Committee (IEC) review and approval
Contract negotiations generally take place with dedicated business offices
The severity of the patients’ conditions in critical care studies results in a much higher incidence of concomitant medications, adverse events and serious adverse events (SAEs) compared to less complex trials

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

Therapeutic Expertise

We have managed Phase I-IV critical care studies for a myriad of disease states, including:

Acute respiratory distress syndrome (ARDS)
AIDS with opportunistic infections
Burns
Coronary artery bypass grafting (CABG) sedation
Emergency room sedation
Head trauma
Hemorrhagic shock
Meningitis
Multiple trauma
Organ transplantation
Sepsis and septic shock
Stroke

Decision-Enabling Technologies

We provide integrated informatics services to critical care drug development programs enabling clients to make more informed drug development decisions. PPD Patient Profiles is sophisticated database transformation and data visualization software that provides insight into trends in efficacy and safety data. FDA reviewers currently use this technology and provide input into its continued software development.