CTI Clinical Trial & Consulting
Transforming Healthcare through Strategic Clinical Development

In 1999, a group of forward-thinking professionals set out to transform the care of the chronically and critically ill. Their passion for advancing medical research and creating better patient outcomes led them to establish CTI Clinical Trial & Consulting—a company dedicated to transforming the healthcare landscape through innovative clinical trials. Over the past 25 years, it has consistently been at the forefront of global healthcare innovation, changing lives and reshaping the future of medicine worldwide.

CTI’s commitment to maintaining rigorous protocols throughout all its operations is a testament to its dedication to quality. Through its clinical research center (CRC), the company runs Phase I-IV studies for its sponsors, ensuring that all research is conducted with the highest standards of care and precision.

“Our pursuit for excellence has enabled us to contribute significantly to the approval of over 150 new drugs and devices spanning a broad spectrum of therapeutic areas, including oncology, cardiovascular diseases, and rare genetic conditions,” says Timothy Schroeder, Chairman and CEO of CTI Clinical Trial & Consulting.

Transforming Therapeutic Approaches for HighImpact Diseases

With a deep commitment to quality and innovation, CTI goes beyond just operating as a contract research organization (CRO)—it is a leader in advancing medical science across a diverse array of high-impact therapeutic fields.

The firm is at the forefront of rare and orphan disease research, adopting a patient-centric approach to drug development. With a multidisciplinary team of experts and state-of-the-art technologies, CTI guides its programs seamlessly through every stage, from regulatory planning to marketing approval. This commitment to advancing medical science is further evidenced by its extensive experience in various therapeutic areas, including nephrology, immunology, hematology, oncology, and neurology.

In addition to these therapeutic capabilities, the company excels in the development of medical devices and in vitro diagnostics (IVD), offering holistic solutions that combine drug and device advancements. This multifaceted expertise positions CTI as a valuable partner committed to delivering comprehensive solutions across various healthcare challenges.

One of the company’s key strengths lies in its contributions to groundbreaking research, particularly on the most vulnerable patient populations—pediatrics and neonates. By researching the unique needs of these patient groups, CTI provides tailored solutions that prioritize their health and well-being. These research capabilities span diverse therapeutic areas, including cardiopulmonary and hepatology. The firm has also significantly contributed to developing several first-approved gene therapy products and is recognized as a leader in transplantation research. Its innovative approaches in this field continue to push the boundaries of treatment possibilities for complex diseases.

Navigating Global Regulatory Challenges

CTI has a deep understanding of the global regulatory landscape, allowing the company to help its partners navigate the complexities of clinical development and ensure their programs are set up for success. The firm’s comprehensive suite of regulatory and strategic services encompasses clinical trial planning and design, medical writing, regulatory strategy, and interactions with global regulatory authorities.

Its medical writing team consistently delivers high-quality submissions, such as new drug applications, biologic license applications, 510(k) premarketing submissions, and clinical study reports. This elaborate regulatory strategy also includes fostering long-term relationships with regulatory bodies such as the FDA and EMA and ensuring effective communication during critical meetings to advance programs and mitigate risks.

Another standout capability of CTI is its model-informed development (MID) group, which applies quantitative modeling and data-informed simulations to optimize clinical trial designs and accelerate the development of medical products. By integrating preclinical data and optimizing dosing strategies, particularly in pediatric, rare disease, and bioequivalence trials, CTI enhances clinical trial efficiency while managing risks. This strategic approach effectively informs regulatory submissions and decision-making.

The firm has consistently demonstrated its ability to drive transformative change in medical research, blending cuttingedge innovation, unparalleled expertise, and a commitment to excellence. As it continues to shape the future of clinical research, CTI remains steadfast in its mission to deliver groundbreaking contributions that will advance healthcare for future generations.