Certificate in Clinical Research Concept

Program helps candidate to learn fundamentals and deep dive into Clinical Trials Domain via theory classes & work on real time case study and project developed by industry experts to enhance their knowledge on SAS Programming.

Duration 48 Days
Certificate SAS Global
Language English


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Course Description

The pharmaceutical industry is bursting at the seams with data and looking for talented, skill full programmers. SAS® is the de facto standard platform used for clinical trials data analysis and reporting for new product submissions to regulatory authorities. SAS® is widely recognized as the gold standard for determining safety and efficacy for clinical trials. SAS® is also the primary mechanism for preparing analysis-ready data for traditional clinical research safety and efficacy analysis activities.  

About Program

Intrdocution to Clinical Trial Programmer is designed to provide candidates with extensive training program to gain deep understanding of End to End Clinical Trial (History, Current Regulations, CDISC, STDM, AaDM). Program covers Clinical Case Study Assignments from different aspects of Clinical trial programming workflow. The program is designed to meet the high demand for trained personnel for human clinical trials.

Program Covers: Theory & Clinical Case Study Projects

This program is part of Certified Clinical Programming Course. Candidates who are SAS® trained and looking for opportunity to learn practical applications of your SAS® knowledge in Clinical Research, hand holding and mentoring by Industry professionals with Internship experience from Multiple Orgranisation which is your gateway to learning beyond geographical barriers. 

Format of Training

Live Web Classroom

Training is Led by an expert instructor live online using live web training platform, and this are not pre recorded lectures. Trainer can virtually look over your shoulder. Discuss, share, exchange ideas with students from different countries. 

Taste of Live Web - is a perfect platform for indivudals who fear online training. SAS® gives an opportunity to all the registrants to have a closer look at different courses given below with a blend of Online Learning. 

All the benefits of the classroom without the travel:

Classroom training options include courses offered in our regional training centers or via our Live Web classroom.

Taught by certified instructors at High-Tech facilities across the country:

  • A SAS expert at your side.
  • Focused learning away from the office
  • Networking opportunities
  • State-of-the-art facilities
  • Electronic course notes downloadable to your device and permission to print
  • Business Knowledge Series: in-depth courses on the latest business topics
  • We offer Connected Classes! Watch for courses in Cary, New York, Arlington, Dallas and San Francisco that connect remote students via our Live Web classroom.

Prerequisite

Candidates Must be SAS Trained 

Graduates or Post Graduates from

  • Life Sciences - B. Sc./ M. Sc.,
  • Pharmacy - B. Pharmacy / M. Pharmacy
  • Statistics - B. Sc. / M. Sc.
  • Medical - MBBS, BDS, BHMS, BAMS
  • Engineering - BE / B. Tech (Biotechnology, Bioinformatics, Computer Science) or M. Tech

Or Relevant experience of pharmaceutical/life science industry

Training Features

48 hours of Instructor-led Classes. 

Course includes embedded practice content for strenthening programming skills. 

Course Curriculum

Clinical Trial Theory

  • Introduction To Clinical Research
  • Basic Pharmacology & Pharmacy in CR
  • New Drug Development
  • Guidelines For Clinical Trials (ICH – GCP)
  • Ethics in Clinical Research
  • Regulations in Clinical Research
  • Biostats & Clinical Trial Designs
  • Clinical Trial Documents
  • Quality in Clinical Trials
  • Clinical Trial Management -Project Management
  • Drug Safety & Pharmacovigilance
  • Clinical Data Management
  • Standards for Clinical Data Interchange – SDTM and ADaM Clinical Trial

Clinical Programming: Project & Case Study

  • CRF Annotation
  • Dataset Development
  • Mapping Dataset (STDM) (Laboratory)
  • ADaM dataset development (ADVS)
  • Creating Adverse Event Summaries
  • Dataset Validation
  • Shift Tables (Laboratory Domain)
  • Generating Tables & Listing
  • Obtaining Descriptive Statistics
  • Generating CRT-DDS Define.xml Files

Certificate

Success Stories

Course Fees