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 through:
- Extensive experience in critical care settings
- A global network of investigators experienced in critical care clinical trials
- Strong relationships with global key opinion leaders
- 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 have conducted more than 16 studies in critical care indications involving more than 6,974 patients and 679 sites in the past five years.1
Critical Care Study Challenges
PPD’s dedicated critical care team works closely with you to meet the special challenges of critical care studies:
- 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.
- PPD’s clinical team has extensive experience working with global clinical coordinating centers.
- Understanding the expectations of local institutional review boards (IRBs) or independent ethics committees (IECs) enables PPD to assist investigative sites in preparing submission documents that result in swift approval.
- Proven ability to overcome the inherent challenges with the informed consent process within the realm of critical care. As many potential subjects will not be able to provide their own informed consent, PPD has the expertise of how to utilize legally authorized representatives (LARs) and knowledge of which countries allow LARs to be utilized to provide informed consent.
- PPD understands the elements essential to trials involving multiple departments, such as emergency rooms, intensive care units, operating rooms, radiology units and blood banks. As a result, we are 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.
- PPD’s past experiences have led to many regional/country-specific best practices with regards to how to maintain site involvement/enthusiasm.
Our clinically trained teams with therapeutic expertise in critical care trials ensure effective trial development and design.
1. Includes stroke experience.