Clinical Research (Decentralised Observational Trials)

Program for Herbal & Nutraceutical Research

Clinical research is undergoing a quiet transformation. With the rise of digital health tools, real-world evidence, and AI-assisted analytics, decentralised observational trials are becoming a powerful approach especially for herbal and nutraceutical products where long-term use, lifestyle context, and safety tracking matter deeply.

The Clinical Research (Decentralised Observational Trials) program is designed to equip students with practical, industry-relevant skills at this intersection of traditional methodology, AI, and digital clinical execution. Structured across four focused sections, the program blends theory, hands-on assignments, and project-based learning.

Literature & Hypothesis: Building the Evidence Foundation

The program begins with strengthening conceptual clarity around observational study designs, including:

• Cohort studies
• Case–control studies
• Cross-sectional studies

Students learn how these differ from randomized controlled trials (RCTs), particularly in herbal and nutraceutical research where ethical, feasibility, and real-world usage considerations often favor observational approaches.

A key emphasis is placed on evidence gap identification. Through guided assignments, students learn to:

• Search and analyze literature on PubMed
• Review registered studies on ClinicalTrials.gov
• Identify under-studied herbs, formulations, populations, or outcomes
• Translate gaps into clear, testable research hypotheses

By the end of this section, students can confidently move from literature review to a well-defined observational research question.

Scientific Prompting for Protocol Development

Modern clinical research increasingly relies on AI-assisted drafting, and this section introduces students to scientific prompting as a research skill.

Students are trained to use AI tools to draft and refine key protocol components, including:

• Inclusion and exclusion criteria
• Case Report Forms (CRFs)
• Patient-Reported Outcomes (PROs)
• Observational trial objectives and endpoints

Alongside prompting practice, students study the standard structure of clinical trial protocols, ensuring AI outputs align with regulatory and scientific expectations. Assignments focus on creating AI-assisted protocol outlines specifically tailored to herbal and nutraceutical observational trials.

This section bridges methodological rigor with efficiency showing students how AI can accelerate, not replace, sound clinical reasoning.

Designing Decentralised Observational Trials

Decentralisation is the core operational theme of the program. Students explore how observational trials can be conducted beyond traditional clinical sites using DCT (Decentralised Clinical Trial) tools, such as:

• Remote patient recruitment
• Digital informed consent (e-consent)
• App-based symptom, adherence, and outcome tracking
• Telemedicine-supported clinician interactions

Learners are introduced to AI-enabled trial infrastructure from Swalife Biotechs, including:

• Telemedicine portals for participant follow-up
• Trial dashboards for real-time study monitoring
• Image-based assessment tools for clinical documentation
• Digital formulation and intake tracking systems

Assignments guide students to design an end-to-end decentralised workflow for an herbal or nutraceutical observational study mapping patient journeys, data streams, and monitoring checkpoints.

Data Interpretation & Capstone Project Submission

The final section focuses on translating collected data into meaningful scientific outputs. Using simulated clinical datasets, students learn to interpret:

• Adherence trends
• Clinical and functional outcomes
• Patient-reported outcomes (PROs)
• Digital engagement metrics

Students are trained to present findings using tables and graphs and to structure results and discussion sections with scientific clarity. The capstone deliverable is a 3–5 page mini project report, written in the IMRaD format (Introduction, Methods, Results, and Discussion) mirroring professional clinical research documentation.

This project serves as tangible proof of the student’s ability to design, analyze, and communicate decentralised observational research.

Outcomes for Students

By the end of the program, students will be able to:

• Understand and apply observational study designs confidently
• Use AI tools for drafting clinical research protocols
• Design decentralised trials using digital and AI-driven platforms
• Interpret observational trial data and prepare professional reports

Bridging Classical Research and Digital Clinical Science

This program equips aspiring researchers with skills that reflect the future of clinical research where herbal and nutraceutical studies increasingly rely on real-world evidence, decentralised execution, and AI-enabled workflows. By combining strong methodological foundations with modern digital tools, the program prepares students to contribute meaningfully to next-generation clinical research ecosystems.

Dr Pravin Badhe
Founder and CEO of Swalife Biotech Pvt Ltd India/Ireland