Therapeutic Areas

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.

Novel and re-surfacing infectious diseases continue to have widespread impact on public health. Vaccine-mediated protection from disease has proven to be an effective shield from human disorders, but its clinical development is a complex challenge. Globally, vaccine development requires mechanistic insight of the human immune system and operational expertise to translate state-of-the-art science to patient care and a successful clinical trial program. KCR has proven experience with vaccine trials and successfully enrolled more than 12,000 subjects to date. KCR’s team of board-certified physicians and solution providers diligently support sponsors through all stages of clinical development including the essential post-vaccine surveillance period.

Gene and cell therapies have provided increasingly optimistic treatment options for rare patient populations. KCR understands the urgent need for these therapies and has developed advanced solutions to ensure seamless knowledge transfer across all drug development stages, enabling trial flexibility, design efficiency and robust endpoints. We align our cutting-edge technology capabilities with the patient landscape to leverage the most agile trial operations. Our experts carefully monitor ever-evolving technical modalities from viral vectors to RNA and gene editing treatments and assess their fit for development and quality-by-design principles to ensure trial approval.