Medpace Holdings, Inc.

Core business

• One of the world’s leading clinical contract research organizations (CROs) by revenue.
• Focuses exclusively on scientifically driven outsourced clinical development services for biotechnology, pharmaceutical, and medical device companies.
• Mission: accelerate global development of safe and effective medical therapeutics.
• Offers full-service Phase I–IV clinical development with a disciplined operating model and therapeutic expertise.
• Positions itself as the partner of choice for small and mid-sized biopharmaceutical companies by delivering timely, high-quality results.

How revenue is generated

• Revenue is generated by providing a full suite of services that support the entire clinical development process from Phase I to Phase IV across multiple therapeutic areas.

Services and capabilities

• Medical Department: therapeutic leads provide strategic direction for study design, training, medical monitoring, and regulatory interaction.
• Clinical Trial Management (CTM): leads study execution; uses ClinTrak, Medpace’s proprietary information management system integrated with SOPs; provides real-time study metrics.
• Data-Driven Feasibility: dedicated team analyzes protocols using multiple data sources to identify optimal countries and sites.
• Study Start-Up: global staff handle submissions to IRBs/ethics committees and ex-US authorities; includes dedicated budget and legal associates for site contracts.
• Patient Recruitment and Retention: develops strategic solutions to address motivators and barriers to joining and remaining in studies.
• Clinical Monitoring: CRAs (in-house, onsite, and virtual) ensure compliance and data quality; operate under a global matrix structure with ongoing training.
• Risk-Based Monitoring: emphasizes prevention and mitigation of key risks to protect subjects and data integrity.
• Regulatory Affairs: provides strategic, operational, and tactical regulatory guidance and documentation.
• Medical Writing: collaborates with medical experts to produce study protocols, reports, and submission documents.
• Biometrics and Data Sciences: handles data collection and management, statistical methodology, programming, and quality control for regulatory submissions.
• Pharmacovigilance: safety data collection, evaluation, analysis, and reporting; global adverse event management.
• Core Laboratory: imaging and cardiovascular core lab services; partners with imaging experts; integrates with ClinTrak.
• Central Laboratory: locations in Cincinnati (US), Leuven (Belgium), Shanghai (China), and Singapore; capabilities in specialized esoteric testing and biomarkers; includes a biorepository and molecular/genetic testing.
• Bioanalytical Laboratory: Cincinnati campus; GLP-compliant; performs method transfer, development, validation, and analysis of clinical samples.
• Clinics: conducts studies in healthy volunteers and various patient populations at the Cincinnati campus.
• Quality Assurance: regulatory training, audits, SOP oversight, site/vendor audits, and inspection support.

Therapeutic focus and market positioning

• Operates across major therapeutic areas with particular strength in Oncology, Metabolic, Cardiology, Antiviral and Anti-infective (AVAI), and Central Nervous System (CNS).

Geographic footprint and facilities

• Central Laboratory locations: Cincinnati, Leuven, Shanghai, and Singapore.
• Bioanalytical Laboratory: Cincinnati, Ohio.
• Clinics: Cincinnati, Ohio.
• Services integrate with ClinTrak for real-time data access and oversight.

Customer base and engagement

• Serves a diversified customer mix, including small biopharmaceutical companies, mid-sized biopharmaceutical companies, and large pharmaceutical companies.
• May enter payment risk-sharing arrangements, flexible terms, or other risk-sharing agreements related to trial execution.

Data and disclosures

• Market and industry data are based on management’s knowledge and publicly available sources; the company does not independently verify all external market data.
• The company uses forward-looking statements and references to “Net New Business Awards and Backlog” in other sections of the annual report.