| United States Food and Drug Administration (USFDA) conducted 8 site Inspection of Patient based PK studies managed by
Veeda Clinical Research in 2016-17 |
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| Veeda CR is glad to share the successful completion of 8 USFDA Inspection at Clinical trial sites for various studies managed by Veeda CR in last financial year - 2016-17.
The studies were conducted in various indications like Chronic Myeloid Leukemia /
GIST, Psoriasis, Rheumatoid arthritis, Advanced Rental cell Carcinoma and Breast Cancer.
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| The Outcome of all the 8 USFDA Inspection in a year was -No 483s,which accounts for a total of 10 out of 11 USFDA Inspections at clinical trials sites with No 483s.
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| Veeda CR team demonstrated excellent overall preparedness for the Inspection with Right First time approach,thorough preparedness for Regulatory inspections at sites and a good process control for study execution. The process control by Clinical Operations team can be demonstrated through the exemplary track record of having completed all the studies within Budget and timelines and in compliance with the applicable Regulatory Requirements.
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| Such a consistent and remarkable feat of 'No 483s' in sequential USFDA Inspections could only be achieved with dedicated and motivated staff geared up to do the right things at the right time in the right method. It is a humbling milestone for Veeda Clinical Operations and Quality Assurance. This was possible due to a highly supportive, passionate and visionary management of Veeda CR who are sensitive to Quality and Regulatory Compliance.
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About Veeda CRVeeda CR is a Contract Research Organization committed to serve its customers with the Best-in-Class Scientific Expertise and Demonstrated Regulatory Compliance. Veeda CR is a trusted partner of choice for conduct of healthy Volunteer BA/BE studies, Patient based PK End-point and PD-End point studies.
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| VEEDA CLINICAL RESEARCH PVT. LTD. Vedant Complex, Beside YMCA club S.G.Highway, Vejalpur,Ahmedabad-380051,Gujarat India Phone: +91 79 3001 3000 | Fax: +91 79 3001 3010 | Email: info@veedacr.com
Website: www.veedacr.com
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