25/09/2013 Computer - Multimedia Classes
We offered training on SAS Clinical Research & SAS Clinical Data Management
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.
Clinical trial protocol & protocol
Essential documents for conduct of clinical trial
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
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