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We offered training on SAS Clinical Research & SAS Clinical Data Management


CLINICAL RESEARCH:
Introduction to clinical research
Introduction to drug discovery and development
Pharmacokinetic (PK) & Pharmacodynamics (PD).
ICH GCP PRINCIPLES
Regulatory authorities involved in clinical research
IRB/IEC responsibilities, composition, functions & operation
Roles and responsibilities of investigator.
Roles and responsibilities of sponsors
Clinical trial audit- In life, retrospective & process audits.
Adverse event (AE), adverse drug reaction (ADR) & Serious adverse event (SAE’s) management.
Essential documentations.
Regulatory submissions.
Clinical trial protocol & protocol
Investigator brochure
Essential documents for conduct of clinical trial
Schedule-Y
Introduction to Biostatistics.
CLINCAL DATA MANAGEMENT (CDM):
Introduction to CDM.
Clinical data management practice
CASE REPORT FORM (CRF) DESIGN.
Electronic data capture (EDC).
Data storage, entry or processing.
Data management metrics.
21 CFR PART 11
Introduction to CDISC.
Introduction to SAS.



For details Please call Arun on 9845382820


TECHSYS
BASAVESHWARANAGAR,BANGALORE

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