EGCP®
EGCP® S.A., excellence in good clinical practice, is a Contract Research Organization (CRO) devoted to provide excellent support and expertise for the conduct of clinical trials in the latin american market for pharmaceutical and biotechnological companies. We help to bring therapies to the market place by providing a full range of services in Clinical Monitoring, Organization and Consulting for Clinical Research Sites, Regulatory Affairs, Representation of emerging Biotech and Pharma Companies, Design, Execution and Analysis of Bioavailability and Bioequivalence studies, Pharmacovigilance services and innovative developing plans of biotechnological products, Consulting.
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| Type | Public / Private |
Contents
History
In October 2005 Dr. Eduardo A. Gallardo decided to bring his 27 years expertise in the pharmaceutical industry having in mind its ethical and excellence values in this field by founding EGCP® S.A. Since its foundation EGCP® S.A. has been working successfully in clinical trials. The first clinical trials were preformed in the field of cardiology. Also EGCP® S.A. represented an american biotechnological company successfully helping the company develop a drug for cystic fibrosis working with the most recognized expertise in Argentina. The first full-service clinical trial in the setting of regenerative medicine was planned and is being executed in collaboration with a local company. All studies were carried out according to FDA, EMEA and local regulations and were audited and inspected successfully.
Services
- Clinical Monitoring.
- Organization and Consulting for Clinical Research Sites.
- Regulatory Affairs.
- Representation of emerging Biotech and Pharma Companies.
- Design, Execution and Analysis of Bioavailability and Bioequivalence studies.
- Pharmacovigilance services and innovative developing plans of biotechnological products.
- Consulting.
Pharmacovigilance services and innovative developing plans
of biotechnological products This unique alliance Boston Buenos Aires through EGCP® and BBCR, offers pharmacovigilance services and innovative developing plans of biotechnological products making the industry incur in less costs and earn efficiency in clinical development. We offer:
- Plan and study designs.
- Regulatory Activities.
- Evaluation of the product’s specification.
- Adverse Event Review.
- Pharmaco-vigilance.
- Data safety Monitoring Board.
- Risk- Benefit Management.
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