Name of the Institute : Six Sigma Academy of Clinical Research (sixsigmabioacademy.com)
Location : Hyderabad
Training Offered : Clinical Research, CDM, SAS, Pharmacovigilence, Medical and Regulatory Writing
https://web.archive.org/web/20140104124433/http://sixsigmabioacademy.com/
Six sigma academy of clinical research offers professional diploma in clinical research ,CDM, SAS, Pharmacovigilance,regulatory and medical writing.All courses are delt by industry experts from cognizant, accenture, Icon and Parexel.Six sigma academy is a service partner of six sigma bio solutions Pvt.Ltd., a Contract Research Organisation (CRO) offering services for pharma,biotech and healthcare industries in medical writing & scientific communications,regulatory writing, clinical trial operations,staffing solutions,corporate training.Six sigma academy offer professional diploma in clinical research with highest quality provided by faculty from industry (usa,uk,europe) with sophisticated labfacility with limited batch size.
Clinical Research Module :
** Drug discovery and development
** Preclinical studies
** Basics of Clinical Trials & Clinical Research
** Terminology & Definitions in Clinical Trials
** Types and Phases of Clinical Trials
** Good Clinical Practices (GCP)
** BA/BE Studies
** Research Methodology & Clinical Trial Design
** Clinical Trial Regulatory Affairs
** Bioethics
** Preparations & Planning for Clinical Trials
** Essential Documentation in Clinical Trials& Regulatory Submissions
** Clinical Trial Operations and Monitoring
** Responsibilities of Clinical Research Professionals
** 21 CFR 11
** Introduction to CDISC
** Informed Consent Document
** Schedule Y
** Protocol Development
** Intellectual property Rights (IPR) and Patent Laws
** SOP development for Clinical Trial Operations
Clinical Data Management Module :
** Introduction to CDM Process
** Data Management Plan
** EDC (Electronic Data Capture)
** CRF Design (Paper)
** e-CRF Development
** Data Validation and Specification (DVS) Development
** CDM QC Testing
** CDM UAT Testing
** Data Processing
** Report generation and data transfer
** Data Cleaning
** Study freezing and Locking
** Open Clinica
(Comprehensive theory and Practical)
** Oracle clinical , RAVE (Overview)
** Extensive Overview of INFORM
** Introduction to MEDRIO
** SOP Development on CDM
SAS Module :
** Introduction to Biostatistics
** SAS 9.1.3 / SAS 9.2
** SAS/BASE
** SAS/STAT
** SAS/PROCEDURES
** SAS/ACCESS
** SAS/SQL
** SAS/GRAPH
** SAS/MACROS
** SAS ENTERPRISE GUIDE4.1
Pharmacovigilance Module :
** Overview of Pharmacovigilance
** Regulatory aspects in Pharmacovigilance
** Periodic Safety Update Reports (PSUR’s)
**Suspected Unexpected Serious Adverse Reactions (SUSAR’s)
** Case report processing
** Eudra Vigilance
** Signal detection process and tools
** Safety Intelligence
** Overview of Pharmacovigilance S/W
Medical, Scientific and Regulatory Writing Module :
** Introduction to Medical writing
** Manuscript writing
** Scientific Slides
** Branding and commercial writing
** Grant writing
** Patient Narratives
** Introduction to regulatory writing
** Investigator Brochure (IB) preparation
** Clinical Study Reports (CSR)
** Protocol writing
** Common Technical Document (CTD/eCTDpreparation
** Dossier submissions (IND/NDA/ANDA)
** ICD translations
Contact us :
Six Sigma Academy of Clinical Research
S.R. Nagar, Opp. Municipal Play Ground
Hyderabad, India
E-mail us [/b]: sixsigmabioacademy@gmail.com, training@sixsigmabioacademy.com