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Location Settings

North America

US -  Boston
US -  San Francisco

Oceania

NZ -  New Zealand
AU -  Brisbane
AU -  Melbourne
AU -  Sydney

Asia

TH -  Bangkok
CN -  Taipei City
KR -  Seoul
PH -  Metro Manila
MY -  Kuala Lumpur
IN -  Bangalore
CN -  Shanghai
CN -  Hong Kong

GLOBAL

English

Asia: Preferred Destination for Clinical Trials

EXECUTIVE SUMMARY

What

The   clinical   trials   process   is   complicated   and   time-consuming,   requiring   substantial   investment.   Biotechnology  and  pharmaceutical  companies  in  the  United  States  (US)  and  Europe  face  escalating  clinical trial costs and challenges in both recruiting and retaining patients. Additionally, companies have to navigate through complex regulatory processes. To   overcome,   these   challenges,   US   and   European   biotechnology   and   pharmaceutical   companies   outsource their clinical studies to contract research organizations (CROs). This white paper highlights research on why Asia is a key destination for clinical trials.

Why

Availability of vast patient pools, high-quality infrastructure, comparable quality and lower costs appeal to US and European companies.

There are 3 key benefits in outsourcing clinical trials to Asia:

  • Resources, Capabilities and Speed: Elements unique to Asia include large treatment-naive patient pools, numerous clinical trial centres with advanced equipment and technology, comparable incidence and prevalence of Western diseases. The region’s knowledgeable physicians and Key Opinion Leaders (KOLs)  provide  attractive  environments  for  clinical  trials  and  facilitate  speedy  trials;  while  low healthcare spend by many governments in Asia makes clinical trials an attractive way for patients to access innovative therapies in these countries.
  • Worldwide Data  Acceptability: Data  from clinical  trials  in  Asia  is  routinely  accepted  as  part  of US Food and Drug  Administration (US   FDA) and   European  Medicines Agency (EMA)   regulatory  submissions. KOLs from Asia are often members of international expert groups and citable academic output from Asia is growing rapidly. Data from inspections conducted in Asia by US FDA and EMA show low levels of adverse findings versus the US or European Union (EU), indicating high international compliance to standards.
  • Cost-Effectiveness: Costs in Asia  for procedures,  diagnostic  tests  and  visits are  generally 30-40% lower than the US and European countries.

Who

Key factors to consider when selecting a CRO:

  • Capability: The CRO should have a capable in-house team with strong project management skills and a  keen  understanding  of  regulatory  requirements.  A  client-centric  and  flexible  approach  to  project  delivery  is  another  attribute  to  look  for.  The  CRO  should  also  offer  scalability  of  IT  systems  and  sophisticated quality systems.
  • Experience: Expertise in specific therapeutic areas, study types and trial phases; proven track record of trials in the biotech sector and with multi-region trials; and a thorough understanding of regulatory audits.
  • Network:  CROs should  have  a local  presence  and  networks,  and  strong  relationships  with  the  principal  investigators, KOLs,  and  institutions. CROs  should  also  be  flexible  in  their approach  to  working with multiple regional specialist CROs.