Embracing Innovation: The

Shift to Technology-Assisted
Authoring in Clinical Research
A Comparative Analysis of Manual and Automated Processes

Presenter: Rakesh Gupta Kotta

(GSK-L2 Interview)
Contents
• Manual vs. Technology-Assisted Authoring of CSR
• Source Files and Quality Assurance
• Main Stakeholders
• Challenges and Solutions
Manual vs. Technology-Assisted Authoring
of CSR
Process steps involved in both styles of authoring

Time and efforts of Medical writer • Developing an dedicated word add-in

as per style guide
7%
Drafting Non Data Sections
10% • Various Steps and components of AI
8%
like
TLFs Collection & Data Analysis
15% o Structured Content Authoring
35%
o Natural Language Processing (NLP)
Drafting of Data Sections
55% o Natural Language Generation (NLG),
17%
o Natural Language Understanding (NLU) and
Review of Drafted Text
20% o Large Language Models (LLMs)
0% 10% 20% 30% 40% 50% 60%
• Reduces the time to interpret and
Technology Assisted Authoring Manual Authoring
summarize various sections
Source Files and Quality Assurance
Source files
• Clinical trial data (SDTM outputs)
• Protocol, SAP and Model reports.

Ensuring quality
• Validation of AI-generated content and
regular updates to software databases
Main Stakeholders

• Medical Writers
• Clinical research teams
• IT department for software
support
Challenges and Solutions

Resistance to • Comprehensive training and

change among staff demonstration of benefits

Data security and • Use of secure, compliant software and

privacy concerns regular audits.

Integration with • Gradual implementation and

existing systems compatibility checks
Thank you..