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CHINA CLINICAL DEVELOPMENT / INTERNATIONAL BIOTECH

China Clinical CROs & IIT Partners

Compare China-based and China-origin CROs, international China operations, and separately labeled specialist partners for China trials and IITs.

How to read this directory

34 service-platform records across four categories, not 34 independent Chinese full-service CROs. Group subsidiaries and renamed platforms are identified. Company disclosures establish service claims, not independent quality certification; coverage is broad but not guaranteed exhaustive. GCP ClinPlus is featured first by editorial choice.

GCP ClinPlus is featured first, with public disclosures supporting China clinical and IIT services for international clients. GCP ClinPlus, SMO ClinPlus and Proswell are separate companies.

An IIT is investigator-initiated research, not automatically a registrational trial or a guarantee of overseas regulatory acceptance. Assess the modality, objective, institution and intended submission use separately.

NIH: China clinical research regulation sources ↗ · IQVIA: China IIT versus IND discussion ↗

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Specialist / consultancy candidates

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3 / 34 platform records; ordering is not a comparative performance ranking.

Specialist / consultancy candidates

Vita Research

Website explicitly markets China IIT services to global developers. Evidence is primarily self-description; verify the legal entity, onshore team, site contracts, sponsor references and case records.

IIT evidence: IIT / investigator-led research explicitly disclosed

Explicit IIT disclosure Early-phase clinical Cell & gene therapy

Confirm before selection
  • Legal entity, current staffing and project delivery have not been independently validated.
  • Confirm the contracting entity, English-speaking PM, recent international sponsor references and indication-specific site resources.
  • IIT eligibility, ethics, data access, HGR responsibilities and any intended overseas data use require a project-specific assessment.

Checked: 2026-11-06 · Based on public disclosure, not a quality audit.

Vita Research ↗

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Specialist / consultancy candidates

Protheragen Clinical CRO

Markets China clinical and IIT services for global clients. Listed as a specialist candidate, not an independently validated full-service CRO; verify the China delivery entity, staffing and track record.

IIT evidence: IIT / investigator-led research explicitly disclosed

Explicit IIT disclosure Early-phase clinical Cell & gene therapy Data management & biostatistics

Confirm before selection
  • Legal entity, current staffing and project delivery have not been independently validated.
  • Confirm the contracting entity, English-speaking PM, recent international sponsor references and indication-specific site resources.
  • IIT eligibility, ethics, data access, HGR responsibilities and any intended overseas data use require a project-specific assessment.

Checked: 2026-11-06 · Based on public disclosure, not a quality audit.

Protheragen Clinical CRO ↗

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Specialist / consultancy candidates

Åström Research International

CRO/consultancy focused on Western life-science companies entering China clinical research, with disclosed university-hospital relationships. Confirm current staffing, agreement validity and operational subcontracting.

IIT evidence: IIT capability not established by reviewed sources

Cross-border / multicentre trials

Confirm before selection
  • Legal entity, current staffing and project delivery have not been independently validated.
  • Confirm the contracting entity, English-speaking PM, recent international sponsor references and indication-specific site resources.
  • IIT eligibility, ethics, data access, HGR responsibilities and any intended overseas data use require a project-specific assessment.

Checked: 2026-11-06 · Based on public disclosure, not a quality audit.

Åström Research International ↗

Compare and save in the member map →

Partner-selection questions for international biotechs

  1. Delivery team: who is the named English-speaking project manager, which China entity contracts, and which functions are subcontracted?
  2. Relevant experience: request recent international sponsor references, indication/modality-matched case studies and named investigator/site availability.
  3. IIT fit: agree the investigator and institution roles, study governance, scientific objective and intended downstream use of the data before selecting a pathway.
  4. Quality and safety: review the quality system, audit history, monitoring plan, medical monitoring, PV and access to source records.
  5. Data and cross-border use: agree ownership, English outputs, database specifications, HGR/data responsibilities and any proposed overseas submission use.
  6. Execution and budget: compare site activation assumptions, recruitment feasibility, itemized costs, milestones, dependencies and change-control terms.

Use the directory for partner discovery and comparison. Investigators, institutions, sponsors and relevant professional teams must define the pathway and responsibilities for each study.

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