We offer training on SAS Clinical Research & SAS Clinical Data Management by industry experts on realtime project. 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. Training offered online and class room mode For details Please call Arun on 9845382820 #378,1st main, rajajinagar industrial town bangalore- 560010 land mark digitally opp planet honda show room
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