International Reach

Supportive of our mission to provide clinical solutions that address business objectives, Accelovance may introduce Sponsors to other markets such as the BRIC countries (Brazil, Russia, India and China) and Central/Eastern Europe as strategic considerations. International markets offer the value of: hard to recruit patients and/or treatment-naïve populations, quality study conduct at a lower cost, ex-US future market registration interests, or accelerated study timelines.

Our North American presence is augmented by an Accelovance CRO team in Beijing, China and strategic partnerships with local CROs in other regions. Sponsors benefit from having a US Project Team managing other regional team members.



Accelovance China

Accelovance China
Why China?

China, the fastest growing pharmaceutical market in the world, can be a favorable location for clinical research to augment enrollment for US/EU studies and/or to support a larger strategy of market registration. As with any country, the perceived value and opportunity must be honestly evaluated. Accelovance relies upon local regulatory experts, strong market knowledge, and industry relationships to evaluate opportunities honestly and execute programs with realistic expectations.

Benefits
  • Large treatment-naïve patient populations
  • Low cost of patient care and management
  • Low cost of conducting clinical research and trials
  • Accelerated enrollment timelines without sacrificing the quality of data
  • Chinese market entry
  • Output data that adheres to FDA, EMEA and ICH GCP standards
  • Increasing government cooperation in improved standards on regulations and IP

 

Regulatory & Market Registration Services

Accelovance uses its expertise, industry knowledge and high-level government and industry relationships to move a product through key areas into China’s pharmaceutical marketplace. With local regulatory and market registration expertise, we assist Sponsor companies with formulating a clinical strategy for China and navigating the SFDA.

In addition to our full-service CRO, Accelovance also offers the following services:

  • Market Research
  • Legal Services (Intellectual Property, Trademark, etc.)
  • Partner Evaluation/Selection
  • Relationship Structure (Joint Venture, Licensing)
  • Joint Venture/Partnership Management Structure
  • Business Formation
  • Import Drug Registration
  • Manufacturing/Packaging
  • Marketing and Sales
  • Distribution

With a presence in both the United States and China, Accelovance can help establish the relationships necessary to optimize product revenue potential in China. Emphasizing value to its pharmaceutical partners, Accelovance is flexible in the way it structures relationships and partnerships. These structures may include the development of joint ventures, licensing, and/or broker/agent. This approach provides our partners with the opportunity to increase their revenue with as little or as much involvement as they require or have the resources to commit.

CRO Capabilities

Accelovance China, Ltd. is a wholly owned foreign entity that enables biotech, small and large pharmaceutical companies to bridge cultural and regulatory barriers while providing flexible CRO services. Each study receives a dedicated team in China as well as US-based project management to facilitate strong communication, high quality study conduct and enhanced control over study deliverables. Tools such as secure study web portals allow Sponsors to have real-time visibility into study progress.

Our CRO services are flexible to meet Sponsor needs, to be a trusted partner in China and to augment internal clinical teams:

  • Regulatory/Protocol Development
  • Project Management
  • Data Management and Statistics
  • Clinical Monitoring
  • Medical Monitoring
  • Medical Writing
  • PH II-IV clinical solutions