A-PACT

Leveraging the track record and expertise of Asia's leading CROs

We have established Alliance for Pac-Asia Clinical Trials (A-PACT) composed of
leading CROs in Japan, China, Korea, and Taiwan.

Our Advantages

About A-PACT

The Alliance for Pac-Asia Clinical Trials (A-PACT) is comprised of leading CROs from Japan, South Korea,
Mainland China and Taiwan.

  • introduction
  • Misson Statement
  • Core Values
  • Reginal Coverage
  • introduction

Introduction

CRO Alliance for Pac-Asia, by Pac-Asia

Experience among the best CROs
Same quality & management platform
Unified service capabilities

Gloval Clinical trial ratio has hovered around 20%

Mission Statement

As a top level CRO Alliance undertaking CRO activities that support the global clinical development of new drugs, molecules and medical devices, A-PACT will continually provide innovative and timely services to the highest quality, to contribute to the development of medicinal and pharmaceutical products as well as the health and quality of life for people all over the world.

Core Values

  • Work Closely as a Team
  • Regional & Global study into One Team on a Local Level.
  • Most Advanced Technology
  • Highest Quality of Service

Regional Coverage

Through unified service capabilities and experience among some of the best local CROs in the key clinical trial areas in PA, we are able to provide you with a one-stop solution to your PA Regional study needs.We can provide you with global management of your clinical studies, as well as consulting services for market and RA feasibility in the PA region, at global quality standards and at a more competitive, local price.

The four founding members include ACM of Japan, C&R Research of South Korea, Rundo International of Mainland China and VCRO of Taiwan, each with a proven track record and strong local market position  Eit was upon this foundation that A-PACT was established.

Members

Please contact us with click on a company logo.

  • ACM

    Japan

    ACM is a one-stop service provider as a CRO, has been merged with Agrex Inc., specialized for DM, and Cronova Inc., specialized for clinical studies.

  • C&R

    Korea

    C&R, one of a biggest/historic CRO in Korea, is the most experienced CRO for phase I-III clinical trial in Korea with 100% KFDA inspection approval records.

  • RUNDO

    China

    Rundo is a full-service Chinese CRO with experience in a wide range of therapeutic areas through Phase I to IV, well-established local networks, extensive local knowledge and a wide geographical spread across the key clinical trial locations in China.

  • VCRO

    Taiwan

    VCRO has the longest experience, and the only CRO with 100% GCP inspection approval in Taiwan.
    It has well-developed IT systems such as EDC, CTMS and IVRS.

Services

  • Strength

    A powerful alliance among leading local CROs with a unified focus on Pac-Asia.

  • Primary Service Territories

    We can conduct several services related to new drug developments upon your request.

  • Experiences

    We can take care of your needs based on our experience by each CRO.

  • Quality

    We strive to meet high quality expectations based on our experiences.

Strengths

Formed by leading local CROs with a unified focus on Pac-Asia clinical studies

  • Strong monitoring and regulatory experience  in each region
  • Extensive Network with Pac-Asia sites, investigators, and health authorities

Harmonized Infrastructure for Asia Clinical Development

  • Unified global SOPs
  • Asia study collaboration experience within A-PACT members

Full-service provider with global standards, local resources and local prices

  • Preferred vendor of multiple Global Pharma companies
  • Local market pricing standards

Primary Service Territories

Strategically planning

  • Development strategy
  • Study design
  • Medical writing
  • Consulting etc….

Regulatory Affairs

  • IND/NDA
  • Ethics committee
  • RA Consulting

Project Management

  • Whole plan of project
  • Evaluation and feasibility
  • Site inspection
  • Monitoring

Data management/STA

  • CRF design
  • Data Cleaning
  • Query Control
  • Statistics
  • CSR

Site management

  • CRC
  • Patient recruitment
  • Deliver of study drug

Others

  • Audit
  • Training and Education
  • Dispatched CRA/CRC/DM
  • GLP Bio-analytical Lab

Experience

Experience Therapeutic Areas

Anesthesiology Hematology Obstetrics and Gyneocology
Biologics Hepatobilliary Oncology
Botanical Medicines Immunology Ophthalmology
Cardiovascular Infectious Diseases Pain Control
Cell Therapy Medical Device Pediatrics
Cosmetic Surgery Metabolism/Endocrinology Pharmacogenomics
Dentistry Muscoloskeletal Physical Medicine and Rehabilitation
Dermatology Nephrology Respiratory Diseases
Diagnostics Nervous System(CNS, PNS) Urology
ENT(Ear, Nose and Throat) Neurology
Gastroenterology Nuclear Medicine

Experience

Collaborative experience within A-PACT

(1) No. of projects by Therapeutic Area

>200

  • Oncology

>150

  • Cardiovascular

>70

  • Central nervous system
  • Enterology
  • Metabolism/
    Endocrinology
  • Respiratory disease

>30

  • Dermatology
  • Diagnostics
  • Hematology
  • Immunology
  • Infection disease
  • Musculoskeletal
  • Nephrology
  • Pain control
  • Medical device

>20

  • Hepatobiliary
  • Neurology
  • Gynecology
  • Obstetrics and Urology

(2) No. of experiences by Phase

Experience

Collaborative Experience within A-PACT

Sponsor Type Study Location Type No. of Sites No. of Subject Therapeutic Area
Korean Sponsor Taiwan Phase II 3 30 Hepatobilliary
Japanese Sponsor Korea Phase IV 25 324 Central Nervous System
European Sponsor China, Korea, Taiwan,
HK, Singapore, Philippines,
Australia, Japan
Phase IV 44 800 Neurosurgery
Japanese Sponsor Japan, China Phase IV   2323 Neurology
Japanese Sponsor Japan, China Phase III   5635 Neurology
Japanese Sponsor Japan, China Phase IV   7053 Neurology
Japanese Sponsor Japan, China Phase III   9568 Neurology

Proof of Quality

China: Rundo International Pharmaceutical Research & Development Co., Ltd.

  • Preferred CRO of numerous global pharma and global CROs
  • 1st CRO in China to obtain ISO 9001:2008 approval
  • The main author of the Chinese Good CRO Practice standards
  • All registration studies audited by the SFDA passed inspection.
  • 1st CRO outside of Japan to perform PV services on behalf of a Japanese Sponsor.

Japan: AC Medical Inc.

  • CDISC Gold Member, 2012-2013
  • ISO 27001: CertiEed by 8Sl Group Japan K.K.
  • All Clinical studies submitted to MHLW for NDA passed PMDA

Korea: C&R Research Inc.

  • 100% KFDA inspection approval records
  • Conducted most Phase I - III trials in Korea
  • Dedicated Oncology and Late Phase Study teams
  • Partner CRO of "National Onco Venture", a government agency focusing on R&D for anticancer drugs
  • QA Service Vendor for the Global Lead Clinical Trials Center (Seoul National University Hospital Consortium)
  • Preferred CRO by multiple Global Pharma and top Korean Pharma
  • Operating ISO 9001:2008 certified C&R Academy. an Education and Training center for Clinical Research Professionals

Taiwan: Virginia Contract Research Organization Co., Ltd.

  • 100% GCP inspection approval record
  • Awarded "No. 1 Taiwan CRO" from the Taiwan National Sciences & Technology Program (Under TFDA) for consecutive 7 years since 2004
  • 1st Taiwan CRO to develop and launch proprietary EDC, CTMS & IVRS systems
  • 1st Taiwan CRO accredited to No. 1:1997 OECD Principles on GLP
  • 1st Taiwan CRO to acquire Oracle Clinical for data management services
  • 1st Taiwan CRO to successfully complete and submit to US FDA IND in CTD for Taiwan initiated NCE (Approval granted 27 days after submission)