Mr. Serrano has over 25 years of clinical research experience working within different therapeutic area for major pharmaceutical Sponsors. Mr. Serrano loves working in a fast pace, rapid fire environment. Mr. Serrano have also worked for several major Pharmaceutical and CRO companies and have learned different aspects of the industry.
Specialties:
• Clinical Monitoring
• Study Start Up
• Regulatory Document (Retrieval, Review, and Archival)
• IRB Submissions (Central and Local)
• Supporting Sponsor and CRO needs
• Excellent Training (Regulatory, GCP, and Monitoring training)
Mr. Shendrikar has over 28 years of combined clinical research experience, working in the site selection, study start up, study close out, data management, QA, regulatory affairs, clinical monitoring, IVRS development and design fields.
Experience with:
•EDC experience including Inform, Ockham, Oracle Clinical and DATATRAK.
•Essential doc
Mr. Shendrikar has over 28 years of combined clinical research experience, working in the site selection, study start up, study close out, data management, QA, regulatory affairs, clinical monitoring, IVRS development and design fields.
Experience with:
•EDC experience including Inform, Ockham, Oracle Clinical and DATATRAK.
•Essential document review, completion and collection.
•Managing and monitoring global studies.
•Extensive knowledge of FDA and ICH Guidelines for Good Clinical Practice.
•Ability to effectively communicate with physicians, medical and research personnel in a professional manner.
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