Siara Limited

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  • About Us
    • Our Company
    • Who we are
    • What we do
  • Solutions
    • Sponsor
    • Investigator
    • Study Coordinator
    • IRB/IEC
    • elearning
  • Module Library
  • Our Clients
  • Our Partners
  • Contact Us
  • More
    • Welcome
    • About Us
      • Our Company
      • Who we are
      • What we do
    • Solutions
      • Sponsor
      • Investigator
      • Study Coordinator
      • IRB/IEC
      • elearning
    • Module Library
    • Our Clients
    • Our Partners
    • Contact Us

Siara Limited

Siara LimitedSiara LimitedSiara Limited
  • Welcome
  • About Us
    • Our Company
    • Who we are
    • What we do
  • Solutions
    • Sponsor
    • Investigator
    • Study Coordinator
    • IRB/IEC
    • elearning
  • Module Library
  • Our Clients
  • Our Partners
  • Contact Us

Module Library

The following modules have been developed Siara for Sponsors and Investigators.  The modules can be delivered on a ‘stand-alone’ basis or a tailored course can be developed comprising of a collection of modules as per client requirements.  Module duration ranges from 0.5 - 1 day.  Each module can be customised for the role, responsibility and experience of the audience.,

Please contact a Siara Consultant for further intimate details on the modules.

Sponsor Training Modules

  • Understanding Clinical Trial Design
  • Working with IECs/IRBs
  • Investigator Selection
  • Informed Consent and the Subject
  • Informed Consent - development and Implementation 
  • Safety in Clinical Trials
  • Drug Accountability
  • Clinical Study Monitoring
  • Monitoring Visit Report Writing
  • Essential Documents & Source Documentation 
  • Developing Recruitment Strategies
  • Risk Based Monitoring
  • Investigator Obligations
  • Sponsor Obligations
  • Investigator Study File Management
  • Sponsor Study File Management
  • Conducting Studies under the US IND
  • Preparing for an Audit
  • Preparing for a Regulatory Inspection

Investigator Training Modules

  • Good Clinical Practice:  An Overview
  • Overview of Drug Development
  • Clinical Research Methodology - The Basics
  • Being an Investigator:  Investigator Obligations
  • Planning for a Clinical Trial
  • Players in Clinical Research
  • ​Role of Sponsor in Clinical Study Management
  • Creating a Clinical Study Budget
  • Taking the Lead in Recruitment
  • Documentation  in Clinical Trials
  • Informed Consent and the Subject
  • Informed Consent - development and Implementation 
  • Conducting Studies under the US IND
  • Safety in Clinical Trials
  • Drug Accountability
  • Essential Documents & Source Documentation 
  • Investigator Study File Management
  • Preparing for an Audit
  • Preparing for a Regulatory Inspection
  • Quality in Clinical Research

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