Recent advancements in immuno-oncology therapies have sparked intense progress in this rapidly-expanding area of clinical research. We recognize that high-complexity early phase studies with adaptive designs demand careful planning in study designs and execution strategies. We support clients through these operational complexities by providing highly specialized management and clinical monitoring teams, access to key networks and investigator sites, all while ensuring total compliance, precision data and cost efficiency.
The NIH estimates there are more than 100 types of autoimmune diseases, that effect more than 5% of the population worldwide. Immunology trials are tricky because patients may have overlapping clinical presentations with uncertain diagnoses or co-morbidity. Thereby, clinical trials may be delayed, as it is challenging to recognize definitive disease patterns, identify treatments and design clinical trials. With significant experience across the immune spectrum, KCR is familiar with these difficulties. We offer sponsors a smoother trial experience because we know how to navigate this uncertain regulatory area. Our management team brings many years of expertise to immune disorder clinical trials across North America and Europe.
Central Nervous System (CNS) clinical trials are complex. Due to increasing numbers of endpoints and management procedures, subjective outcome measures, and variability in rater experience, inconsistency in data quality is common. Our therapeutic experts, network of experienced sites across the world, and extensive knowledge of local standards of care assure effective patient recruitment and comprehensive data delivery. Our teams are trained on and utilize cutting edge scientific advancements in CNS diseases and evolving regulations.
Pediatric clinical studies invite a variety of difficult circumstances pertaining to concerns around patient recruitment, parental consent and high-risk childhood diseases. Because many pediatric diseases are rare disorders, getting enough patients recruited to satisfy statistical requirements is one of the challenges that often leads to high failure rates in pediatric trials. To combat this, our clinical teams work across regions to design studies considering local healthcare specifics, with parents and families at the forefront.
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