Medpace Holdings, Inc. operates as a clinical contract research organization (CRO) worldwide. The company solely focuses on providing scientifically-driven outsourced clinical development services to the biotechnology, pharmaceutical and medical device industries.
Revenues: Markets and Clinical Development Services
The company generates its revenues by providing a full suite of services supporting the entire clinical development process from Phase I to Phase IV across a wide range of therapeut...
Medpace Holdings, Inc. operates as a clinical contract research organization (CRO) worldwide. The company solely focuses on providing scientifically-driven outsourced clinical development services to the biotechnology, pharmaceutical and medical device industries.
Revenues: Markets and Clinical Development Services
The company generates its revenues by providing a full suite of services supporting the entire clinical development process from Phase I to Phase IV across a wide range of therapeutic areas.
Medical Department: The company’s medical department consists of therapeutic leads who provide strategic direction for study design and planning, train operational staff, work with primary investigators, provide medical monitoring and meet with regulatory agencies.
Clinical Trial Management: The company’s team of clinical trial managers (CTMs) lead all aspects of study execution and drive accountability across the functional team members. The company’s CTMs use ClinTrak, its proprietary information management system for clinical trials, which is integrated with its standard operating procedures (SOPs), allowing the CTMs to access real-time study metrics.
Data-Driven Feasibility: The company’s dedicated feasibility team of clinical experts analyze specific protocols, using many data sources to determine countries and sites that are most appropriate for the study.
Study Start-Up: The company’s global Study Start-Up staff conducts trial start up activities, including study documentation submission processes to independent Institutional Review Boards, or IRBs, ethics committees and to ex-US competent authorities. The company’s study start-up team includes fully dedicated budget and legal associates to ensure focused negotiations and execution of site contracts.
Patient Recruitment and Retention: The company navigates the complexities of patient recruitment and retention by providing strategic solutions that address clinical program needs. The company’s patient recruitment and retention department identify patient motivators and any potential barriers to join and remain in the clinical research study.
Clinical Monitoring: The company’s clinical research associates, or CRAs, provide site management services including in-house, onsite and virtual monitoring. Their knowledge of local regulations and laws, in addition to Good Clinical Practice, or GCP, and International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, guidelines ensure compliance and data quality. CRAs report into a global matrix structure and receive comprehensive, hands-on training in an individualized curriculum consisting of in-house and field-based training, supplemented with clinical research department core rotations and ongoing study-specific training.
Risk-Based Monitoring: The company supports a comprehensive approach to monitoring to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity of the study. This approach focuses on prevention and mitigation of important and likely risks and is part of the overarching surveillance utilized to manage studies.
Regulatory Affairs: The company provides expert strategic, operational, and tactical regulatory guidance, and create thorough scientifically-grounded regulatory compliant documentation at each stage of the drug and biologics development process to regulatory agencies around the globe.
Medical Writing: Medical writers work closely with the company’s medical experts, biostatisticians, and other members of the study team to develop study protocols, clinical and statistical study reports, and integrated submission documents according to regulatory guidelines.
Biometrics and Data Sciences: The company provides high-quality data collected during clinical trials that supports regulatory submissions, including NDAs or Biologics License Application for approval by the FDA, or a similar marketing authorization application for approval by non-U.S. regulatory agencies. The company’s data science team develops detailed specifications for the collection, organization, validation, analysis and quality control of clinical trial data. The company’s biostatisticians provide trial design consulting, statistical methodology recommendations, programming expertise and reporting accuracy.
Pharmacovigilance: The company’s safety and pharmacovigilance group collects, evaluates, analyzes and reports safety information. The company provides global adverse event management, physician reviewed safety narrative writing and custom safety surveillance.
Core Laboratory: The company’s core laboratory services include both imaging services and cardiovascular core laboratory services. The company partners with imaging experts from major academic and clinical institutions involved in research to provide image reading in a secure environment utilizing identical software and workstations integrated into ClinTrak allowing for prompt turnaround and oversight. The company’s cardiovascular core laboratory provides state of the art standardized electrocardiogram services and data analysis.
Central Laboratory: The company’s Central Laboratory operates in four locations, including Cincinnati, Ohio; Leuven, Belgium; Shanghai, China; and Singapore. The Central Laboratory has longstanding core competency in specialized esoteric testing, including biomarkers for efficacy in addition to standard assay offerings. The company also provides biorepository services offering solutions for comprehensive specimen life cycle management, and molecular and genetic testing for detection of pathogenic events at the genome level, including viral load and viral shedding.
Bioanalytical Laboratory: The company’s Bioanalytical Laboratory is located on its clinical research campus in Cincinnati, Ohio. Working in a Good Laboratory Practice compliant setting following FDA and European Medicines Agency, or EMA, guidelines, the Bioanalytical Laboratory delivers method transfer, development, validation, sample analysis and metabolite screening and identification of pre-clinical and clinical biological samples with expertise in developing proprietary, highly scientific, esoteric and sensitive tests for small and large molecules.
Clinics: The company’s clinics conduct studies in normal healthy volunteers, special populations, and patient populations over a spectrum of diseases and is located on its clinical research campus in Cincinnati, Ohio.
Quality Assurance: The company’s quality assurance team works closely with study teams to ensure compliance with protocols, SOPs and regulatory guidelines to ultimately protect research subject safety as well as the integrity and validity of study data. The company’s quality assurance team also provides services including regulatory training, internal system audits, SOP oversight, hosting of audits and regulatory inspections, as well as performs third party audits of critical vendors and investigative sites on behalf of its customers.
Customers
The company has a well-diversified, attractively-positioned customer base that includes small biopharmaceutical companies, mid-sized biopharmaceutical companies and large pharmaceutical companies.
Sales and Marketing
The company employs an integrated sales and marketing team to sell its services to biotechnology, pharmaceutical and medical device companies. The team consists of professional business development representatives focused on securing business from both new and existing customers, through a consultative and strategic sales approach. The company embeds its medical and scientific experts from the beginning of the sales process when it first engages potential customers.
The company consults collaboratively with its customers and help optimize timely completion of their clinical trials and programs, in part, because it engages its therapeutic experts, regulatory affairs experts and operations team throughout the clinical trial process. The company’s sales team is then able to take the study design, regulatory plan and execution plan discussed up front and carry that through to the proposal and provide a final concept during one-on-one customer discussions and final CRO evaluations.
The company’s marketing team supports the business development function in three key areas, generating brand awareness through customized campaigns and web-site development, conference planning and lead generation through market research and business intelligence analysis. All of the company’s sales and marketing data are housed within a third party customer relationship management tool that provides it the analytics it needs to make sales planning and sales management decisions.
Government Regulation
The company’s services are subject to varying regulatory requirements designed to ensure the quality and integrity of the pre-clinical and clinical trial process. In the United States, the FDA has primary authority to regulate these activities, in addition to the approval process, and the subsequent manufacturing, safety, labeling, storage, record keeping and marketing for these products, which are the responsibility of its customers.
In order to comply with GCP and other requirements, the company must, among other things, comply with specific requirements governing the selection of qualified principal investigators and clinical research sites; obtain specific written commitments from principal investigators; obtain IRB review and approval and supervision of the clinical trials by an independent review board or ethics committee; obtain a favorable opinion from regulatory agencies to commence a clinical trial; verify that appropriate patient informed consents are obtained before the patient participates in a clinical trial; ensure that adverse drug reactions resulting from the administration of a drug or biologic during a clinical trial are medically evaluated and reported in a timely manner; monitor the validity and accuracy of data; monitor drug or biologic accountability at clinical research sites; and verify that principal investigators and clinical trial staff maintain records and reports and permit appropriate governmental authorities access to data for review.
Two of the company’s subsidiaries, Medpace Clinical Pharmacology, LLC and C-MARC, LLC, are covered entities under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and their implementing regulations, including the Privacy and Security Rules (HIPAA). Further, many investigators with whom the company is involved in clinical trials are also directly subject to HIPAA as covered entities.
In addition, the company is subject to privacy legislation in the jurisdictions in which it operates, which includes privacy legislation in the EU under the 95/46/EC Privacy Directive on the protection and free movement of personal data, as replaced by the General Data Protection Regulation from early 2018 onwards.
Intellectual Property
The company has obtained or applied for trademarks and copyright protection in the United States and in a number of foreign countries. Its material trademarks include Medpace and ClinTrak.
Competition
The company’s major CRO competitors include IQVIA Holdings Inc.; ICON plc; PPD, Inc. (part of Thermo Fisher Scientific Inc.); Fortrea, Inc.; and numerous specialty and regional CROs.
History
Medpace Holdings, Inc. was founded in 1992. The company was incorporated in 2014.