ECRON ACUNOVA
 
 
 
 
Region
 
The selection of countries is optimized to meet the sponsor’s commercialization interest as well as each country’s suitability for the conduct of clinical studies.

  • Clinical development requires that country choice is based on patient availability, site experience, study start-up time, and country risk. EA has long experience and relationship with investigators in fast recruiting geographies of the world.
  • For example, a product intended for global release will seek marketing permission in the major markets, Typically USA, EU and Japan. EA has extensive experience in conducting clinical studies for marketing approval by USFDA, EMA and MHW.
     
Asia Pacific

Many Asia Pacific countries offer special advantages for clinical research including: patient availability, trained investigators, sites with inspection history and a globally compliant ecosystem. For example, Thailand  has played a pivotal role in global HIV drug research and has established a positive reputation for quality clinical research. Singapore has retained a preeminent KOL status for Southeast Asia (SEA). World class medical infrastructure and government incentives have made it an attractive city for early clinical development studies.

India has grown to be the back office for global clinical research. CDM, safety and pharmacovigilance service are well established in these areas and offer global sponsors significant cost-savings. The Generic drug  industry has strong roots in India as BA/BE studies have migrated to India from most Western countries.

EA Has Deep Experience in Asia/SEA:
  • Strong geographical presence. EA has offices in  9 Asian/SEA countries (plus further nations with authorized partners).
  • Marketing Authorizations: EA has successfully conducted global clinical studies in Asia Pacific and obtained for sponsors marketing authorizations in the key markets of Japan, Korea, China, Australia and India.
  • Successful Regulatory Audits: Studies have undergone inspections by global and local regulators.
  • Regulatory Expertise: EA has experience in navigating the regulatory pathway for new drugs (NCE, NBE, Biosimilars, Devices) with regulators in Singapore, Thailand and India.
  • GCP: Services in all countries served by EA are GCP compliant.
USA/Canada

EA’s contribution to clinical research in North America:
  • Local offices: With offices in Princeton, NJ, San Antonio, TX, Denver, CO and Toronto, Canada,  EA manages studies across the North American continent.
  • FDA experience:  EA successfully supported sponsors to obtain marketing authorization in US by contributing in IND meetings with the FDA and by defending study reports.
  • Met or exceeded recruitment goals: Experienced project managers and monitors have long-standing relationship with key clinical research sites. This forms a core part of our team in the US and Canada. EA has consistently met recruitment goals in global studies in North America and we have successfully met regulatory inspection by US FDA and Health Canada.
  • From our Toronto office we can structure contracts for Canadian sponsors to take advantage of existing  tax incentives.
 


Western & Eastern Europe / Nordic Countries

Western Europe and the  Nordic countries have a long history of drug development and a mature clinical research infrastructure. The European Union (EU) under regulatory oversight of European Medicine Agency (EMA) offers sponsors either a central permission or country specific permission. Central permission has become increasingly popular with sponsors.

Eastern Europe is known for high recruitment rates, very good patient compliance and competitive costs.

EA has proven track record in Europe:
  • 28+ years of clinical study performance.
  • Strong geographical presence, covering 19 countries in Europe, including key EU markets.
  • Successfully conducted pivotal studies for central EMA permission and from leading national regulatory agencies.
  • Vast experience with local European Health Authorities.
  • Awareness of country specialties (local languages, laws, health environment, submission requirements, site contracts) enables optimization of time lines and study schedules.
  • Solid relationship with key opinion leaders (KOL) and fast recruiting sites.
  • Fast and cost-effective access to patient populations at large, therapeutically-specific Eastern European hospitals.
  • Fast recruitment and excellent compliance at Eastern European sites (due to centralized health
    system and medical environment).
  • Considering language diversity in Europe: CRAs speak English and the local language; with sensitivity to translation issues.
South America / MENA

Leveraging long standing partners, we also provide services in South America and MENA region.
 
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Asia Pacific
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Western & Eastern Europe / Nordic Countries
South America / MENA
 
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