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Virginia Contract Research Organization Co., Ltd.

 Founded in Taiwan in 1997, VCRO has expanded to China and the US. Specializing in contract clinical research for new drug development, VCRO excels in regenerative medicine and gene therapy. It is recognized as the most professional and experienced CRO in the Asia-Pacific region.

About us
New Alzheimer’s Drug TML-6 Begins Phase II Clinical Trials in Taiwan and the U.S.

New Alzheimer’s Drug TML-6 Begins Phase II Clinical Trials in Taiwan and the U.S.

2025-07-11
Alzheimer’s Health Supplement Proven in Animal Studies to Improve Cognitive Function and Delay Aging In addition to developing the new…
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U.S. FDA releases updated guidance on donor eligibility determination for HCT/Ps (Part 1.)

U.S. FDA releases updated guidance on donor eligibility determination for HCT/Ps (Part 1.)

2025-05-23
In January 2025, the U.S. Food and Drug Administration (FDA) released six updated guidance documents about donor eligibility determinations for…
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U.S. FDA Releases Draft Guidance on Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics (Part 3.)

U.S. FDA Releases Draft Guidance on Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics (Part 3.)

2025-04-10
Additional Requirements Information Transparency: Drug labeling for accelerated approval products must clearly disclose limitations, uncertainties about anticipated clinical benefits, and…
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U.S. FDA Releases Draft Guidance on Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics (Part 2.)

U.S. FDA Releases Draft Guidance on Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics (Part 2.)

2025-04-01
Evidentiary Criteria for Accelerated ApprovalDrugs under accelerated approval must meet the same statutory standards for safety and effectiveness as those…
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U.S. FDA Releases Draft Guidance on Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics (Part 1.)

U.S. FDA Releases Draft Guidance on Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics (Part 1.)

2025-03-24
In December 2024, the U.S. Food and Drug Administration (FDA) released a new draft guidance titled “Expedited Program for Serious…
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Beneficial regeneration dual method through Hexun exosomes to transfer heat

Beneficial regeneration dual method through Hexun exosomes to transfer heat

2024-08-16
Benefiting from Taiwan’s major breakthroughs in the cell therapy market this year, including the Ministry of Health and Welfare’s conditional…
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FDA promotes AI technology program

FDA promotes AI technology program

2024-07-26
The Artificial Intelligence Program at the FDA’s Center for Devices and Radiological Health (CDRH) is one of the 20 research…
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Event Review-2024 Shanghai Medical Device Product Overseas Commercialization Conference

Event Review-2024 Shanghai Medical Device Product Overseas Commercialization Conference

2024-07-19
Vice President Thomas Jaw of VCRO Shanghai was invited as a lecturer for the event. He provided an overview of…
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Taipei Medical University Registration Office Recruitment for Credit Program in Clinical Trials

Taipei Medical University Registration Office Recruitment for Credit Program in Clinical Trials

2024-07-12
The objectives of the program are: To train students to become familiar with the principles, regulations, design, and practice related…
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Great news! TCR-T Cell therapy for HPV-related solid tumors has received FDA approval for Phase I/II clinical trials.

Great news! TCR-T Cell therapy for HPV-related solid tumors has received FDA approval for Phase I/II clinical trials.

2024-07-05
VCRO’s professional team assisted in preparing the submission to the US FDA for a clinical trial of client’s TCR-T cell…
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What we do

Service Scope

VCRO has been in the market for 28 years, providing a complete one-stop service from IND to NDA. From medical affairs, regulatory affairs, clinical operations, data management and statistics, to EDC remote electronic data capture systems and IWRS, VCRO supports a complete service structure with more than 600 case experience and has delivered 54+ US FDA IND and 98+ GCP inspection.

54+ US FDA IND

Cell therapy, CAR-T, LBP, Gene therapy, nucleic acid drugs , miRNA , NCE , 505b2……

The counters

Full Service Capability

VCRO is extremely confident that we can customize the scope of services for you based on your needs and achieve project success.

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Therapeutic Area

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Clinical Trial

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US FDA IND

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GCP Inspection

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