CRO/CMO정보
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[국외CRO/Consulting]Medpace, Inc
| 작성자 | 관리자 | ||
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| 작성일 | 2015-04-03 | 조회수 | 256 |
| 원문 | 한국보건산업진흥원 | ||
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1. Corporate General Information
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Corporate Name |
Medpace, Inc |
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Corporate Ownership |
Private Company |
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Head Office Address |
5375 Medpace Way |
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Facilities City & Country |
Cincinnati, OH 45227, USA |
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Korean Business Office |
Opening 2012 |
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Web-site Address |
http://www.medpace.com |
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No. of Employees |
1,100 |
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Financial Status |
Sales Revenue in 2010(US K$) |
Capital(US K$) |
Dept-equity Ratio(%) |
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US$180,230,000 |
US$68,378,000 |
0.84 |
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Contact (Korean Business) |
Name |
Nicholas Allen |
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Address |
5375 Medpace Way, Cincinnati, OH 45227USA |
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Telephone |
+1-919-651-9012 |
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n.allen@medpace.com |
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Company History |
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Medpace was founded in 1992 providing support services to Medical Research Services a central clinical laboratory in Cincinnati becoming an independent company in 1997. Since the organization has grown both in the US and globally to have offices in all the major regions of the world, Latin America, Eastern and Western Europe, South Africa and Asia Pacific. The company had grown organically with only a few strategic acquisitions to expand expertise and service offerings. In 2008 Medpace built its state-of-the-art 64-bed Clinical Pharmacology Unit and added a bioanalytical laboratory (Medpace Bioanalytical Laboratory -MBL) to provide bioanalytical services and support phase I studies. In 2009 central laboratory locations were added in Beijing, China and Mumbai, India to support the growing number of clinical studies in the Asia-Pacific region. In 2010 Medpace acquired a medical device CRO that is now known as Medpace Medical Device. |
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Company Description & Organization |
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Medpace is a leading global full-service Contract Research Organization (CRO) providing Phase I-IV development services for biopharmaceutical and device clinical trials. Medpace has medical, regulatory and operational expertise in multiple therapeutic areas to provide complete and seamless drug development services. The company has a global reach with more than 1,100 employees in 40 countries and can support clinical trials from program planning and execution to product approval. In addition to clinical staff Medpace has a central laboratory with locations in the US, Europe, China and India to support studies wherever they are conducted. |
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2. Corporate Service & Business Area
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Corporate Main Service Area |
Contract Research & Development |
Contract Manufacturing |
Contract Sales & Marketing |
Consulting |
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Geographical Business Area |
Contract Research & Development |
Contract Manufacturing |
Contract Sales & Marketing |
Consulting |
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US |
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US |
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US |
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US |
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Canada |
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Canada |
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Canada |
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Canada |
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EU |
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EU |
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EU |
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EU |
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Asia |
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Asia |
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Asia |
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Asia |
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Global |
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Global |
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Global |
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Global |
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Other |
Latin America, South Africa |
Other |
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Other |
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Other |
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Focusing Contract Service Area |
Contract Research & Development |
Contract Manufacturing |
Contract Sales & Marketing |
Consulting |
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Research |
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API |
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APIs |
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R&D |
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Pre-Clinical |
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R&D Strategy & Management |
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Pre-clinical Test Sample |
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Phase I |
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Clinical Trials |
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Phase II |
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Clinical Test Sample |
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Finished Products |
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Regulatory Affairs |
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Phase III |
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Business Development |
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Finished Product |
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Phase IV |
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Sales & Marketing |
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Corporate Product Area |
New Drug |
Biologics |
Herbal Medicine |
Biosimilars |
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NCE |
NME |
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Generics |
APIs |
Devices |
Others |
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3. Corporate Business Overview
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Clients' Composition (%) |
Big Pharmas |
Mid or Small -Size Pharmas |
Biotech Companies |
Start-ups |
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12% |
20% |
60% |
8% |
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In-house Facilities |
Research & Development |
Preclinical |
Clinical |
Custom Manufacturing |
Custom Sales |
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• Medpace CRO • Central Reference Laboratories • 64 Bed Clinical Pharmacology Unit • Bioanalytical Laboratory • Core Imaging Laboratory • Medical Device |
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Phase I - IV |
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Focusing Therapeutic Area |
Oncology, Metabolism, Cardiovascular, CNS, Infectious Disease, Nephrology, Medical Device |
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General Overview of Corporate's Key Contract Services |
• Clinical Operations • Medical Writing • Biometrics • Regulatory Affairs • Quality Assurance • Pharmacovigilance • Cardiovascular Core Laboratory • Pharmacokinetics • Electronic Adjudication Services • Clinical Pharmacology • Bioanalytical Services • Core Imaging Services • Central Laboratory Services Medical Device Development |
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Contract Service Capacity Affordable by Service Area |
Medpace offers drug and device development services for all stages of development and has the supporting services to seamless integrate the service offerings creating efficiencies of time. The clinical team has strong support in medical writing, regulatory affairs, clinical safety, medical monitoring, data management and statistical analysis. In addition the central laboratory, bioanalytical laboratory, imaging capabilities and cardiovascular core laboratory are valuable additions to the core contract research services. |
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Communication with Clients |
Dispositoion of Project Manager Responsible |
The Clinical Trial Manager is the central point of contact and responsible for all aspects of a program. S/he establishes timelines is responsible for deliverables and coordinates the internal resources required to execute a program. |
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Providing Realtime Service Delivery |
Medpace has its own custom-built and maintained clinical trial management system ClinTrak® that provides real-time information through a secured web portal. It provides key information on the progress of study and can be used to print out status reports and graphics. |
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Realtime Feed-back |
ClinTrak® provides feedback in a customizable format. |
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4. Corporate Competitiveness
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Corporate Competitiveness |
Medpace has a successful track record of regulatory marketing applications in Europe and the US and has successfully completed 27 New Drug Applications (NDAs) in the US. In addition Medpace has obtained regulatory approval to begin clinical trials in over 40 countries including Korea and China. The company’s regulatory focus together with its strong expertise in both medical and scientific areas has proven the company’s competitive advantage for almost 20 years. |
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No. of Regulatory Inspections |
Classification |
FDA(US) |
EMA(EU) |
PMDA(Japan) |
Others |
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Pre-Clinical Area |
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Clinical Area |
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Manufacturing Area |
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Others |
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Current Status of Accredited Certification |
GLP, GCP, ICH, CAP |
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5. Collaboration Experiences with Asian Pharmaceutical & Biotech Companies in recent 3 years
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Countries which clients belong to |
China, Japan, Korea, Taiwan, Hong Kong, Singapore |
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Asian Clients' Composition(%) |
Big Pharmas |
Mid or Small -Size Pharmas |
Biotech Companies |
Start-ups |
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60% |
20% |
20% |
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No. of Asian Clients in recent 3 years |
22 |
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Major Service Range with Asian Companies |
Contract Research & Development |
Contract Manufacturing |
Contract Sales & Marketing |
Consulting |
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Research |
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API |
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APIs |
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R&D |
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Pre-Clinical |
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R&D Strategy & Management |
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Pre-clinical Test Sample |
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Phase I |
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Clinical Trials |
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Phase II |
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Clinical Test Sample |
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Finished Products |
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Regulatory Affairs |
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Phase III |
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Business Development |
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Finished Product |
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Phase IV |
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Sales & Marketing |
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