Navigate the Complexities of In-hospital Critical Care Studies
Critical care studies are fraught with challenges including volatility of patient health, the need for rapid interdepartmental communication at sites, elevated mortality rates and consent concerns. Our extensive experience in critical care means we are adept at overcoming common challenges to quickly move your program forward.
PPD’s Experience in the past five years
Critical care studies
Critical care patients
We offer nuanced approaches that address common issues such as:
- Informed consent — We have proven processes to facilitate emergency consent using legally authorized representatives (LARs) per country-specific regulatory guidelines, if a patient is unable to consent.
- Management of inter-departmental relationships — Not only do we select the right sites, but we also work to ensure that all involved departments (emergency rooms, intensive care units, radiology units, etc.) have a well-scripted, trial-specific plan to smoothly work together and overcome obstacles.
- Complex local regulations — Our understanding of the expectations of local institutional review boards or independent ethics committees helps pave the way to submission documents that result in swift approval.
- Investigator engagement — We have developed many regional/country-specific best practices to actively engage investigators as early as possible in the process and maintain site involvement and enthusiasm.
- Post-transplant complications
- Ventilator-associated pneumonia
- Acute respiratory distress syndrome
- Brain injury
In Settings Including:
- Emergency rooms
- Intensive care units (ICU)
- Operating rooms
- Radiology units
- Blood banks
Global Professionals with In-hospital and ICU Experience
We have a team of professionals with critical experience, including
those who have worked as nurses and physicians in an ICU setting. Not only do they understand how to conduct quality clinical trials in a high-stakes critical care setting, they will also help you anticipate the expectations of local institutional review boards and independent ethics committees and plan for informed consent challenges with strategies that include utilization of LARs.
In addition, we maintain relationships with key opinion leaders and give you access to a global network of seasoned critical care investigators and hundreds of qualified sites in all regions.