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CRO/CMO정보

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[국외CRO/Consulting]Medpace, Inc

[국외CRO/Consulting]Medpace, Inc : 작성자, 작성일, 조회수, 원문,출처, 정보 제공
작성자 관리자
작성일 2015-04-03 조회수 256
원문 한국보건산업진흥원
출처
  

 

 Medpace, Inc

 

 

 

1. Corporate General Information

 

Corporate Name

Medpace, Inc

Corporate Ownership

Private Company

Head Office Address

5375 Medpace Way

Facilities City & Country

Cincinnati, OH 45227, USA

Korean Business Office

Opening 2012

Web-site Address

http://www.medpace.com

No. of Employees

1,100

Financial Status

Sales Revenue in 2010(US K$)

Capital(US K$)

Dept-equity Ratio(%)

US$180,230,000

US$68,378,000

0.84

Contact

(Korean Business)

Name

Nicholas Allen

Address

5375 Medpace Way, Cincinnati, OH 45227USA

Telephone

+1-919-651-9012

E-mail

n.allen@medpace.com

Company History

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.

Company Description & Organization

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.

 

2. Corporate Service & Business Area

 

Corporate Main

Service Area

Contract Research

& Development

Contract

Manufacturing

Contract Sales &

Marketing

Consulting

 

 

Geographical

Business Area

Contract Research

& Development

Contract

Manufacturing

Contract Sales &

Marketing

Consulting

US

US

 

US

 

US

Canada

Canada

 

Canada

 

Canada

EU

EU

 

EU

 

EU

Asia

Asia

 

Asia

 

Asia

Global

Global

 

Global

 

Global

Other

Latin America, South Africa

Other

 

Other

 

Other

 

Focusing Contract

Service Area

Contract Research

& Development

Contract

Manufacturing

Contract Sales &

Marketing

Consulting

Research

API

 

APIs

 

R&D

Pre-Clinical

 

R&D Strategy

& Management

Pre-clinical

Test Sample

 

Phase I

Clinical Trials

Phase II

Clinical Test

Sample

 

Finished

Products

 

Regulatory

Affairs

Phase III

Business

Development

 

Finished

Product

 

Phase IV

Sales &

Marketing

 

Corporate Product Area

New Drug

Biologics

Herbal

Medicine

Biosimilars

NCE

NME

 

Generics

APIs

Devices

Others

 

 

 

3. Corporate Business Overview

 

Clients' Composition

(%)

Big Pharmas

Mid or Small

-Size Pharmas

Biotech

Companies

Start-ups

12%

20%

60%

8%

In-house Facilities

Research &

Development

Preclinical

Clinical

Custom

Manufacturing

Custom Sales

• Medpace CRO

• Central Reference Laboratories

• 64 Bed Clinical Pharmacology Unit

• Bioanalytical Laboratory

• Core Imaging Laboratory

• Medical Device

 

Phase I - IV

 

 

Focusing Therapeutic Area

Oncology, Metabolism, Cardiovascular, CNS, Infectious Disease, Nephrology, Medical Device

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

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.

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.

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.

Realtime

Feed-back

ClinTrak® provides feedback in a customizable format.

 

4. Corporate Competitiveness

 

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.

No. of Regulatory

Inspections

Classification

FDA(US)

EMA(EU)

PMDA(Japan)

Others

Pre-Clinical Area

 

 

 

 

Clinical Area

 

 

Manufacturing Area

 

 

 

 

Others

 

 

 

 

Current Status of

Accredited Certification

GLP, GCP, ICH, CAP

 


5. Collaboration Experiences with Asian Pharmaceutical & Biotech Companies in recent 3 years

 

Countries which

clients belong to

China, Japan, Korea, Taiwan, Hong Kong, Singapore

Asian Clients'

Composition(%)

Big Pharmas

Mid or Small

-Size Pharmas

Biotech

Companies

Start-ups

 

60%

20%

20%

No. of Asian Clients

in recent 3 years

22

Major Service Range

with Asian Companies

Contract Research

& Development

Contract

Manufacturing

Contract Sales &

Marketing

Consulting

Research

API

 

APIs

 

R&D

 

Pre-Clinical

 

R&D Strategy

& Management

 

Pre-clinical

Test Sample

 

Phase I

Clinical Trials

Phase II

Clinical Test

Sample

 

Finished

Products

 

Regulatory

Affairs

Phase III

Business

Development

 

Finished

Product

 

Phase IV

Sales &

Marketing