Complex Clinical Trials & Vulnerable Populations

Clinical trials are increasingly complex due to expanding regulatory requirements, especially in drug development for novel treatments such as cell and gene therapies, oncolytic viruses, biologics, and personalized medicines. At Ergomed, our team of experts excels in planning and executing complex trials involving vulnerable populations, including children and those with rare diseases. We navigate intricacies from early-phase, first-in-human studies to large-scale, multicenter trials, instilling confidence in our clients.

Complex Clinical Trials Expertise and Experience

Complex clinical trials require a CRO with a solid scientific team, extensive regulatory knowledge, a compassionate approach to improving the patient experience, and the expertise to support clinical sites and investigators in patient recruitment, safety, and protocol compliance.

Building on a rich history of working with some of the most medically fragile patient populations, Ergomed has developed specific processes and tools that optimally operationalize even the smallest detail of your complex trial design. We understand that complex trial designs may involve hospitalized patients or those admitted in urgent or emergent situations and require the cooperation and coordination of care providers who may not be part of the clinical research team. These situations increase the need for more attention to detail to guarantee compliance with your protocol.

Our commitment to detail is particularly evident when managing Advanced Therapy Medicinal Products (ATMPs). These products often come with specific transport, storage, and administration requirements. We leave no stone unturned in study planning and execution, down to the minutes it takes to transport a critical ATMP from the pharmacy to the patient. This level of precision is a testament to our commitment to detail, providing reassurance to our clients about the maintenance of product efficacy.

Read Our Case Study

Strategic Site Selection and Site Management Support

Ergomed’s site management service and site-level study mapping process establish your study plan at the patient level, so protocol follows the patient through any and all care-level transitions. All data sources are pre-identified, so there are no gaps in data continuity. Our deep understanding of the regulations and guidelines for vulnerable populations further verifies your trial’s compliance.

Our site management services provide support beyond the traditional monitoring model. Study procedures during complex clinical trials may be outside the standard of care in more extensive, logistically more challenging studies that involve multiple procedures, vendors, and a high volume of clinical visits. Site motivation and awareness must also be maintained in rare disease studies, and patient recruitment and retention require additional attention, which our site managers provide.

Patient-Centric Approach for Vulnerable Populations

When it comes to studies involving vulnerable populations, such as neonates, those with impaired cognitive autonomy, or individuals with life-limiting conditions, Ergomed’s approaches are characterized by a profound sensitivity. We are well-versed in the relevant regulations and guidelines in these settings.  Our commitment is to conduct the study and work closely with our sponsors to treat every participant with the utmost respect and dignity. We view our role as supporting their journey of hope; this commitment is at the heart of everything we do.

Ergomed’s unique patient-centric approach recognizes the crucial role of families in the care of vulnerable patients. Backed by the knowledge and expertise of our Patient Engagement Team, we offer a wide range of patient concierge services to increase the recruitment and retention of vulnerable populations and ensure a successful trial.

Effective Enrollment Strategies

We involve Key Opinion Leaders (KOLs) early in the planning process to leverage their expertise to impact study design and recruitment strategies. Additionally, we improve patient enrollment and study outcomes by implementing preliminary assessments and maintaining a pipeline of potential participants to ensure smooth enrollment. Each study and site are unique, so Ergomed also focuses on unique enrollment strategies.

Read Our Datasheet

Navigating Complex Clinical Trials with Precision and Compassion

Ergomed stands at the forefront of navigating the complexities of clinical trials, especially those involving vulnerable populations and cutting-edge treatments like cell and gene therapies. Our sophisticated solutions, underpinned by meticulous attention to detail, allow us to execute every aspect of your trial flawlessly. From strategic site selection and site management to patient-centric approaches and effective enrollment strategies, Ergomed combines expertise, compassion, and precision to drive successful outcomes.

Patient-Focused, Ergo, Better Trials

Contact Us

Our Complementary Services

See how Ergomed can support your clinical trial.

More Ergomed Services

Find out how Ergomed supports your clinical trial objectives.

Discover Our Latest Insights

Access Ergomed's resources for the latest in clinical trial trends and innovations.