CTI Clinical Trial and Consulting Services

Meet Kathrin Copley, Senior Director of Regulatory & Scientific Affairs at #TeamCTI. Kathrin plays a fundamental role in developing regulatory strategies for drug and device development, guiding clients through key phases such as Pre-IND, IND, NDA, and BLA submissions. She leads and contributes to the creation of critical regulatory and scientific documents, ensuring compliance with global regulations. Kathrin also provides expert guidance to project teams, facilitates interactions with regulatory authorities, and mentors colleagues. Her leadership and expertise support CTI's success in the regulatory and scientific fields. #MovingMedicineForward #ClinicalResearch #ClinicalTrials #RegulatoryAffairs #ScientificAffairs

Are you attending Alliance for Regenerative Medicine's Meeting on the Mediterranean in Rome? CTI experts Timothy Schroeder, Savannah Doliboa, MBA, Rui Melo, and Helen Nelson are sponsoring and attending this conference.? Connect with our team to explore the latest advancements in the cell and gene therapy field, covering topics from market access to regulatory challenges. With experience supporting over 1,200 sites for global programs, learn how CTI navigates the complexities of cell and gene therapy research. Contact Patrick Klesa to meet with our team! #MovingMedicineForward #MOTM2025 #CellTherapy #GeneTherapy #CG

We are proud to be recognized by the American Society of Transplantation's Living Donor Circle of Excellence, honoring companies committed to removing barriers to living organ donation. At CTI, we support this cause through our organ donor leave policy, part of our employee incentive program. Join the Circle of Excellence today: https://lnkd.in/gUsqjvmM Sign up to become an organ donor: https://lnkd.in/eDr2WFd #MovingMedicineForward #AST #Transplantation #OrganDonor

#TeamCTI is at the forefront of ensuring regulatory excellence to support marketing applications. Our Regulatory & Scientific Affairs team provides expert regulatory, CMC, non-clinical, clinical, and medical writing support, interacting with global regulatory health authorities like the FDA, EMA, Health Canada, and MHRA. They assist in developing regulatory strategy and expedited pathway submissions, gap analyses to identify points to be addressed in a development program, preclinical development planning for IND, CTA, IDE readiness and design clinical trials with the end goal of marketing authorization, authoring key clinical documents such as protocols, investigator brochures, and study reports. Additionally, they contribute to nonclinical and CMC technical documentation, including nonclinical study reports and Investigational Medicinal Product Dossiers (IMPDs), supporting Investigational New Drug (IND) and global marketing applications. Their work ensures successful submissions and approvals, driving innovation and #MovingMedicineForward. #RegulatoryAffairs #ScientificAffairs #ClinicalResearch #ClinicalTrials

Yesterday, we proudly hosted a Hoxworth Blood Center Blood Drive ???? at our global headquarters, bringing our team together to make a life-saving impact. A huge THANK YOU to everyone who rolled up their sleeves to donate! Our annual blood drive is just one of the many ways we're committed to supporting the communities where we live and work. Together, we're making a difference! #MovingMedicineForward #CTICares #BloodDrive #ClinicalResearch

We are proud to recognize Kelsey Blaze, Clinical Project Manager III, in this week's spotlight. Kelsey expertly plans, implements, and oversees the execution of clinical trials, ensuring compliance with ICH, GCP, and regulatory guidelines. With strong leadership and a focus on team motivation, she ensures projects meet timelines, budgets, and quality standards on a global scale. Kelsey's dedication to positive trial outcomes and client success makes her an invaluable part of #TeamCTI. #MovingMedicineForward #ClinicalResearch #ClinicalTrials #ProjectManagement

???? At CTI, giving back is part of who we are. Through CTI Cares, our employee-driven initiative, we're dedicated to sustainability, education, and healthcare. On #GlobalRecyclingDay, we celebrate our teams around the world who are taking action for a cleaner, greener future. Small actions have a big impact. How are you making a difference today? #MovingMedicineForward #CTICares #ClinicalResearch #ClinicalTrials

CTI is proud to have led some of the largest renal transplant studies to date, with the most extensive footprint in the field. We are committed to #MovingMedicineForward and improving patient care. To learn more, please visit our website: https://lnkd.in/dw3YkPSy #ClinicalResearch #ClinicalTrials #Transplantation

We are proud to spotlight CTI's Clinical Project Management (CPM) team! From collaborating directly with sponsors and project teams to managing timelines, budgets, and quality, our CPM team ensures that every aspect of the trial lifecycle runs smoothly. They develop comprehensive trial plans, create project-specific training and documents, and maintain the Trial Master File with precision. As the main point of contact for trial sponsors and vendors, they oversee project milestones, track progress, and keep the team updated. Thank you to our CPM team for their dedication and expertise in #MovingMedicineForward! #TeamCTI #ClinicalResearch #ClinicalProjectManagement

Today is World Kidney Day, a reminder that 850 million people worldwide are affected by chronic kidney disease (CKD). At CTI, we're committed to making a difference. With a global footprint in key regions like MEA and Southeast Asia, we specialize in clinical trials for rare and chronic kidney diseases—driving research forward to improve patient outcomes. Our expert RSA and MID teams create efficient development plans, accelerating progress where it matters most. Because every breakthrough brings us closer to better treatments. #MovingMedicineForward #WorldKidneyDay #AreYourKidneysOK