Comprehensive Training Program on Pharmacovigilance, Medical Writing, Clinical Data Management and Clinical SAS.

The course is designed for Life Science candidates who aspires to build career in the Pharma and Clinical World. A comprehensive 4 Module Program – covering complete knowledge on Pharmacovigilance, Medical Writing, Clinical Data Management and Base SAS. The Course is designed and Structured to meet the demands of the Industry and career aspirations of the students. With a flexibility to Choose all the 4 modules or any of the specific selected Module only. Aspirants are free to choose a combination of modules which he is interested in.

The Program Includes Official SAS Certification Exams, Official Course Material, Genuine Software and trainings by Experts in the relevant field.

Course Outline:

Module 1: SAS Programming 1: Essentials

  • Navigate the SAS windowing environment
  • Navigate the SAS Enterprise Guide programming environment
  • Read various types of data into SAS data sets
  • Create SAS variables and subset data
  • Combine SAS data sets
  • Create and enhance listing and summary reports
  • Validate SAS data sets.

SAS Programming 2: Data Manipulation Techniques

  • Control SAS data set input and output
  • Combine SAS data sets
  • Summarize, read, and write different types of data
  • Perform DO loop and SAS array processing
  • Transform character, numeric, and date variables.

Module 2: Pharmacovigilance

  • Introduction to Pharmacovigilance
  • Clinical Development process
  • Responsibilities :USFDA, CDSCO
  • Pharmacovigilance in India
  • Drug Safety in clinical trials and post marketed drugs
  • Different sources of Adverse events reporting
  • Different types of AE reporting Forms
  • Adverse events and its types
  • Expedited reporting and its timelines
  • Four minimum information for a reportable case
  • Seriousness criteria of adverse event
  • Expectedness ( Listedness) of adverse event
  • Causality assessment of the adverse event
  • Case Narrative writing
  • Case processing
  • Periodic Safety Update Report (PSUR) and its submission timelines
  • Development Safety Update Report (DSUR)
  • Roles & Responsibilities in a CROs & Sponsor in Pharmacovigilance.
  • Medical Dictionary for Drug Regulatory Activities – MedDRA
  • Overview of Oracle Argus

Module 3: Medical writing

  • General introduction
  • epidemiology and ebm
  • pharmaceutical medicine
  • basics of good medical writing
  • computer skills
  • overview of the regulatory, marketing and drug promotion processes
  • common technical document
  • protocol, investigator’s brochure & case report forms
  • clinical study report
  • sentence control
  • writing flow and cohesiveness
  • publication writing
  • documents in medico-marketing
  • managing the review process

Module 4: Clinical Data Management

  • Introduction to CDM
  • Data collection instruments
  • CRF designing elements
  • Paper based CRF designing
  • Data Entry, remote data entry
  • Electronic data Capture
  • e-CRF designing
  • Data quality management plan
  • Data Validation
  • Query management
  • Open Clinica – Role based access as Monitor
  • Open Clinica- Role based access as Data manager
  • Open Clinica – Study creation and designing
  • Open Clinica CRF designing
  • Open Clinica metadata
  • MedDRA
  • Annotated CRFs
  • Overview Oracle clinica
All 4 Modules
Complete Program
INR 60000 88 Hours
Official Base SAS
Online-Live Web
INR 33000 40 Hours
Classroom Session
INR 15000 22 Hours
Medical Writing
Classroom Session
INR 11000 10 Hours
Clinical Data Management
Classroom Session
INR 14000 18 Hours

The SAS® Global Certification Program allows you to validate your SAS® software skills and earn the globally-recognised credential endorsed by SAS®.

Official SAS Curriculum

Official SAS curriculum is delivered only by SAS Accredited Training Centres. IQPRO is an Accredited SAS Training Partner.

Accredited Trainers

SAS Accredited trainers, besides being expert in their subject matter, communicate the SAS official curriculum very effectively using internationally accepted & proven instructional skills.

Proven Pedagogy

Pedagogy is designed using a combination of comprehensive course notes, lectures, hands-on exercises, software demonstration, assessments & more.

Digital Badges

SAS Digital Badge – With real-time verification, colleagues and potential employers have a clear view of what you’ve learned through your SAS® training.

Earn a Digital Badge

Stand out from your peers. You’ve earned it.
When you earn an internationally recognized credential from SAS, you also earn a digital badge that you can share on your social media sites.

Contact Phone

+91 6309812365

Office Address

401, 4th Floor, Osman Plaza, Above Centro,
Punjagutta RD#1, Nagarjuna Circle,
Hyderabad, Telangana – 500034

We help You to Learn SAS® From e-learning to video tutorials, learn SAS in the way that works best for you.

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