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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
Major Milestone Achieved! VCRO Powers Multinational Clinical Development for UCAR-T Therapy

Major Milestone Achieved! VCRO Powers Multinational Clinical Development for UCAR-T Therapy

2026-08-26
Phase II Clinical Trial for Recurrent Glioblastoma (rGBM) Cleared by Both US FDA and Taiwan FDA (TFDA), Set to Launch…
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Major Milestone! VCRO Advances 505(b)(2) Novel Fixed-Dose Combination Product into US Clinical Development

Major Milestone! VCRO Advances 505(b)(2) Novel Fixed-Dose Combination Product into US Clinical Development

2026-08-19
Phase I + Phase II Clinical Development Plan for a Novel Fixed-Dose Combination Drug in Erectile Dysfunction Successfully Cleared by…
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FDA Draft Guidance Clarifies Use of Overall Survival in Oncology Trials (Part I.)

FDA Draft Guidance Clarifies Use of Overall Survival in Oncology Trials (Part I.)

2025-12-23
Overall survival (OS), defined as the time from treatment initiation until death from any cause, is widely considered the most…
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Guidance from the U.S. FDA on Clinical Trial Development for Weight Loss Medications

Guidance from the U.S. FDA on Clinical Trial Development for Weight Loss Medications

2025-09-22
With the rise of “weight loss injections” led by Eli Lilly’s tirzepatide and Novo Nordisk’s semaglutide, the obesity treatment market…
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U.S. FDA releases updated guidance on donor eligibility determination for HCT/Ps (Part 2.)

U.S. FDA releases updated guidance on donor eligibility determination for HCT/Ps (Part 2.)

2025-08-04
2. Updated Screening Criteria for RCDADs The revised specific guidance outlines updated risk factors and deferral periods. Key changes for…
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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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What we do

Service Scope

VCRO has been in the market for 29 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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