Critical Care
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.
Our critical care experience in the past five years
Critical care studies
Global sites
Critical care patients
Addressing common issues with a nuanced approach
Embark on your critical care studies with confidence knowing that you are backed by our dedicated team of critical care experts. We enable you to skillfully navigate the complex web of regulatory, compliance and operational challenges unique to each country and study. By anticipating and addressing common issues, we expertly and seamlessly guide your study from start to finish.
- Informed consent — Successfully navigate the acute care consenting process, using legally authorized representatives (LARs) or independent physicians per country-specific regulatory guidelines, if a patient is unable to consent.
- Interdepartmental relationships — Selecting the right sites is critical to your success, and we go the extra mile to ensure that all involved departments (e.g., emergency rooms, intensive care units, infectious disease service, blood bank) have a well-scripted, trial-specific plan to smoothly work together and overcome obstacles.
- Local regulations — Pave the way to submission documents that result in swift approval by leveraging our understanding of the expectations of local institutional review boards (IRBs) or independent ethics committees.
- Investigator engagement — Actively engage investigators as early as possible in the process and maintain site involvement and enthusiasm using our many regional/country-specific best practices.
Executing adult and pediatric critical care studies across multiple therapeutic areas
In the past five years, our dedicated critical care team has executed studies in more than 50 countries across over 20 indications spanning the critical care continuum. As the only CRO with a dedicated critical care unit, our team has unparalleled experience in complex, inpatient, acute care studies, including:
- Acute heart failure
- Acute ischemic stroke (AIS)
- Acute kidney failure
- Acute liver failure
- Acute respiratory distress syndrome (ARDS)
- Acute traumatic brain injury (TBI)
- Disseminated intravascular coagulopathy (DIC)
- Hemorrhage
- Myocardial infarction
- Neonatal necrotizing enterocolitis (NEC)
- Post-surgical /post-transplant complications (anemia, etc.)
- Prevention of bronchopulmonary dysplasia (BPD)
- Prevention of retinopathy of prematurity (ROP)
- Sepsis / septic shock
- Severe burns
- Ventilator-associated pneumonia (VAP)
Conducting trials in critical and acute care settings with specialized expertise
Research in critical care settings presents unique challenges for researchers. Unlike other studies, we cannot identify and schedule patients in advance. Instead, subjects must be rapidly identified and enrolled as they present for treatment for specific injuries, illnesses or post-surgical complications that fall within the scope of the study. In some cases, the identification and enrollment process may begin upon notification from EMS that a patient is en route. Our commitment to early and active investigator engagement ensures that all involved departments, such as ICUs, emergency, radiology and others, are well-prepared in advance, enabling a fully coordinated and rapid response.
Critical care settings include:
- Blood banks
- Burn units
- Emergency departments
- Intensive care units (ICU)
- Neonatal intensive care units (NICU)
- Operating rooms and surgical units
- Operating rooms and surgical units
- Radiology units
Global in-hospital, surgical and ICU experience
Our team of professionals includes nurses and physicians with acute care setting experience. They understand how to conduct quality clinical trials in a high-stakes critical care setting, and they work with you to anticipate the expectations of local institutional review boards and independent ethics committees and plan for informed consent challenges with strategies that include use of LARs. Additionally, 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. Our approach ensures you have access to the deep expertise across the multiple practice areas necessary to support critical care trials with extensive therapeutic area knowledge.
Our acute care expertise spans multiple therapeutic areas including:
Bring life-changing therapies to patients faster with our comprehensive suite of products and services, which provide the flexibility to support major activities throughout each study phase to optimize drug development time and cost. Our streamlined model reduces the complexity of working across multiple partners, reduces time-consuming handoffs and enables our team to proactively anticipate and act upon your needs.