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 leverages our local regulatory experts, strong market knowledge, and industry relationships to evaluate opportunities honestly and execute programs with realistic expectations.

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

  • Import drug registration to CFDA
  • Medical device registration to CFDA
  • US FDA submissions
  • Manufacturing/packaging/distribution
  • Business formation
  • Business formation
  • Relationship structure (joint venture, partnership, licensing)
  • Partner evaluation/selection
  • Legal services (intellectual property, trademark, etc.)
  • Market research

With a presence in both the US and China, Accelovance can help establish the relationships necessary to optimize product revenue potential in China. Accelovance emphasizes value to pharmaceutical partners by offering flexibility in structuring 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.

Therapeutic expertise includes biologics, small molecules, devices and diagnostics, cell and gene therapy, nutrition/supplements, and vaccines. As a trusted partner in China, our Phase I-IV CRO services are flexible to meet Sponsor needs and can augment internal clinical teams with the following services:

  • Project management
  • Data management
  • Biostatistics
  • Clinical trial monitoring
  • Medical monitoring, pharmacovigilance, medical information (hotline service)
  • Medical writing, including protocol, IB, ICF, PSUR, RMP, CSR
  • Regulatory services (GxP auditing, import drug and medical device registration to CFDA, US FDA submissions)
  • Risk management
  • Training, Study coordinator and site support services
  • Manufacturing/packaging/distribution
  • Business formation, partner evaluation, market research
  • Legal services (intellectual property, trademark, etc.)

 

 

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 intellectual property

Capabilities in China

  • Project management
  • Data management
  • Biostatistics
  • Clinical trial monitoring
  • Regulatory services
  • Medical monitoring
  • Medical writing
  • Study coordinator and site support services
  • Postmarketing pharmacovigilance
  • Risk management
  • Manufacturing/packaging/distribution
  • Market research
  • Business formation, partner evaluation