Six Sigma Academy Hyderabad www.sixsigmabioacademy.com : Clinical Research, CDM, SAS, Pharmacovigilence Training

[muthukalee]

Company Name : Six Sigma Academy of Clinical Research (sixsigmabioacademy.com)
Company Location : Hyderabad
Designation (of vacancy) : Job oriented training on Clinical Research, CDM, SAS, Pharmacovigilence, Medical and Regulatory Writing
Company E-mail ID : sixsigmabioacademy@gmail.com
Company Website : www.sixsigmabioacademy.com

Job Description, Candidate Profile, Company Profile, Company Address :

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.

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

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

More Information about this submission and submitter :
Submission ID : 6039297
Date & Time : 17th Sep 2012 6:09 AM (UTC)
IP Address : 183.82.129.30
Browser info : Mozilla/5.0 (Windows NT 6.1) AppleWebKit/537.1 (KHTML, like Gecko) Chrome/21.0.1180.89 Safari/537.1
Predicted Country : India

[Guest]

I have completed B.Pharm in 2012. I want to join in Six Sigma Academy. How can I join?

Six Sigma Academy of Clinical Research (SACR) is the subsidiary of Six Sigma Biosolutions Pvt. Ltd, a quality driven contract research organization (CRO) providing services to the global pharmaceutical, biotech, health care and medical device companies.

Six Sigma Bio (SSB) offers services in the areas of Medical and Regulatory writing, Contract trial execution, GCP training, Independent auditing, Clinical trial document translations.

You may contact the Six Sigma Academy for further details in this link
http://www.sixsigmabioacademy.com/contact.html

[Guest]

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 lab facility with limited batch size.

MODULE I:CLINICAL RESEARCH
MODULE II: CLINICAL DATA MANAGEMENT
MODULE III: SAS
MODULE IV: PHARMACOVIGILANCE
MODULE V: MEDICAL, SCIENTIFIC AND REGULATORY WRITING

Call us for more info @ 9989021111
E-mail us :
training@sixsigmabioacademy.com,
sixsigmabioacademy@gmail.com

www.sixsigmabioacademy.com