CTI Clinical Trial and Consulting Services

Background

CTI Clinical Trial and Consulting Services (CTI) is a global, privately held, full-service contract research organization (CRO) founded in 1999. The company specializes in delivering comprehensive clinical trial and consulting services throughout the development lifecycle, from concept to commercialization. CTI's mission is to support the advancement of life-changing therapies, particularly for chronically and critically ill patient populations. The company's therapeutic expertise encompasses rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations.

Key Strategic Focus

CTI's strategic focus is centered on providing specialized therapeutic expertise to pharmaceutical, biotechnology, and medical device firms. The company emphasizes:

Rare Diseases and Regenerative Medicine: CTI has a strong commitment to supporting research in rare diseases and regenerative medicine, including cell and gene therapies.

Global Expansion: Through strategic acquisitions, such as Dynakin in Europe and Clinart in the Middle East and Northern Africa, CTI has expanded its global footprint to better serve clients worldwide.

Operational Excellence: CTI has been recognized for its operational excellence, being named the #1 CRO in the world for quality at the 2020 CRO Leadership Awards.

Financials and Funding

CTI is a privately held company with estimated annual revenues of approximately $85.7 million. The company has experienced consistent growth, expanding its employee base and global presence through strategic acquisitions and organic growth.

Pipeline Development

As a CRO, CTI collaborates with pharmaceutical and biotechnology companies to plan, manage, and analyze clinical trials across various therapeutic areas. The company's focus includes:

Rare Diseases: Supporting the development of therapies for rare and orphan diseases.

Regenerative Medicine: Facilitating research in cell and gene therapies.

Infectious Diseases: Managing clinical trials for treatments targeting infectious diseases, including COVID-19.

Technological Platform and Innovation

CTI leverages advanced technological platforms and proprietary methodologies to enhance clinical trial efficiency and data integrity. Notable aspects include:

Pharmacometrics Services: Through the acquisition of Dynakin, CTI has integrated drug modeling services that support dosing and regulatory decisions at all development stages.

Integrated Clinical Research Sites: CTI offers fully integrated multi-specialty clinical research sites capable of conducting Phase I-IV trials, ensuring comprehensive support for clients.

Leadership Team

CTI's leadership team comprises experienced professionals dedicated to advancing clinical research:

Timothy J. Schroeder: Founder and CEO, providing strategic direction and oversight.

Patrick J. Earley: Chief International Business Officer, leading global expansion initiatives.

Alaa Assem, MD, MBA: Managing Director, MENA, overseeing operations in the Middle East and Northern Africa.

Leadership Changes

In recent years, CTI has expanded its leadership team through strategic acquisitions:

Dr. Monica Rodriguez and Dr. Nerea Leal: Co-founders of Dynakin, joined CTI in new roles integral to the company's growth.

Maria João Queiroz and Inês Costa: Leaders from Eurotrials, continued to play significant roles within CTI following the acquisition.

Competitor Profile

Market Insights and Dynamics

The global CRO market is highly competitive, with significant growth potential driven by increasing demand for outsourced clinical research services. Key trends include:

Emphasis on Rare Diseases: Growing focus on developing therapies for rare and orphan diseases.

Technological Integration: Adoption of advanced technologies to enhance trial efficiency and data management.

Competitor Analysis

CTI operates alongside several key competitors in the CRO industry:

Medpace: A global CRO with estimated revenues of $1 billion, offering comprehensive clinical development services.

Worldwide Clinical Trials: Provides full-service CRO solutions with revenues between $100 million and $1 billion.

IQVIA: A leading global provider of advanced analytics, technology solutions, and contract research services, with revenues exceeding $1 billion.

Covance: Offers drug development services, including preclinical and clinical research, with revenues over $1 billion.

PRA Health Sciences: A full-service global CRO with revenues exceeding $1 billion.

Strategic Collaborations and Partnerships

CTI has engaged in strategic collaborations to enhance its service offerings and global reach:

Acquisition of Dynakin: Strengthened laboratory services and pharmacometrics capabilities in Europe and the MEA region.

Acquisition of Clinart: Expanded presence and expertise in the Middle East and Northern Africa.

Acquisition of Eurotrials: Enhanced Real World Evidence capabilities and presence in Europe and Latin America.

Operational Insights

CTI's strategic considerations include:

Global Expansion: Through acquisitions, CTI has established a presence in over 60 countries across six continents, enhancing its ability to manage multinational clinical trials.

Therapeutic Expertise: The company's focused approach in specialized therapeutic areas differentiates it from competitors and positions it as a leader in complex clinical research.