ADVANCED CLINICAL RESEARCH TRAINING PROGRAM 2026

Featuring Dedicated AI Modules in Clinical Research

100 Days LIVE Training | 100 Sessions | 16 Advanced Modules | APPLIED PROJECT WORK

Choose 3, 6 or 12 Months of Mentored Applied Project Work

Beginner-Friendly • Advanced Learning • Practical Workflows • Applied Project Work

Placement Assistance | Training Certificate | Project Certificate | Work Experience Letter

STARTS 18th SEP 2026

Build Advanced Clinical Research Skills for Today’s Evolving Industry

Clinical research is rapidly changing with the introduction of Electronic Data Capture systems, decentralised trials, remote monitoring, digital biomarkers and Artificial Intelligence.

The Advanced Clinical Research Training Program is a structured 100-day learning journey that begins with clinical research fundamentals and progresses to advanced trial operations, regulatory processes, clinical data management, monitoring, pharmacovigilance, quality assurance, EDC tools, decentralised trials and AI-enabled clinical research.

After completing the training, learners can choose a 3-month, 6-month or 12-month mentored applied project track to build practical skills and create an industry-relevant project portfolio.

Program Details

• Training Duration: 100 Days
• Total Sessions: 100 Sessions
• Curriculum: 16 Structured Training Modules
• Project Options: 3, 6 or 12 Months
• Learning Format: Concept Sessions, Live Q&A, Hands-on, Demonstrations, Activities and Applied Project Work
• Next Batch Starts: 18th SEP 2026
• Class Timing: 7:30 - 8:30 PM IST
• Credentials: Training Certificate, Project Certificate (If you have opted for Project work) and Work Experience Letter (Applicable with 6 & 12 Months of project work)
• Career Support: Industry Readiness and Placement Assistance

Placement Success Stories

BioTecNika learners have progressed into clinical research roles across CROs, research organisations and healthcare companies, including organisations such as Advarra, IQVIA and other clinical research employers.

 

Employment outcomes vary according to qualifications, skills, experience, performance, interview results, available openings and individual employer requirements.

Why Choose This Advanced Clinical Research Program?

1. Foundation-to-Advanced Curriculum

Begin with essential clinical research concepts and gradually progress to clinical trial operations, data management, monitoring, quality, regulatory submissions, EDC systems and advanced digital applications.

2. Dedicated AI Modules in Clinical Research

Understand how Artificial Intelligence and Machine Learning are being applied across clinical trials, including:

• AI and machine learning applications in clinical trials
• AI-supported patient recruitment and screening
• AI tools used in clinical research workflows
• AI-enabled decentralized clinical trials
• AI-based clinical trial workflow demonstrations
• AI skills and future career pathways in clinical research

3. Hands-on EDC and eCRF Workflows

Learn practical clinical data workflows covering:

• EDC systems and Castor EDC
• Electronic Case Report Form design
• Study visits and workflow development
• Participant enrolment and data entry
• Validation rules and edit checks
• Query management
• Source Data Verification
• Adverse event data entry
• Database review, lock and export

4. Advanced Clinical Trial Operations

Develop an understanding of documents and workflows used throughout a clinical trial, including:

• Protocol, ICF and CRF/eCRF
• Trial Master File and Investigator Site File
• Site feasibility and initiation
• Trial monitoring and close-out
• Risk-Based Monitoring and RBQM
• Quality systems, audits and CAPA
• Regulatory submissions and inspection readiness

5. Flexible Applied Project Tracks

Choose a project duration based on your learning goals and the depth of portfolio you want to develop:

• 3-Month Track: Focused skill application and first portfolio development
• 6-Month Track: Deeper operational, analytical, dashboard or data-focused execution
• 12-Month Track: End-to-end capstone specialization and comprehensive professional portfolio

6. Industry and Career Preparation

Receive guidance on:

• Clinical research career pathways
• Current hiring and skill trends
• Resume and LinkedIn profile building
• Interview preparation
• Professional communication
• Trial simulations and industry assessments

Download Course Brochure

Course Curriculum: 16 Comprehensive Modules

Module 1: Introduction to Clinical Research and the Healthcare Industry

• Healthcare, pharmaceutical and clinical research industries

• History and evolution of clinical trials

• Drug development overview

• Clinical trial terminology

• Career opportunities in clinical research

Module 2: Drug Discovery and Preclinical Development

• Drug discovery and target identification

• Lead identification and optimization

• Preclinical pharmacology and toxicology

• GLP principles and animal studies

• IND applications and transition to human studies

Module 3: Human Clinical Trials and Trial Phases

• Clinical trial life cycle

• Phase 0, I, II, III and IV trials

• Parallel, crossover, adaptive, basket and umbrella designs

• Randomization, blinding and control groups

• Clinical trial endpoints and outcome measures

Module 4: Global Regulatory Environment and Ethics

• ICH guidelines and ICH E6(R3)

• FDA, EMA, MHRA, PMDA, Health Canada, TGA, NMPA and CDSCO

• Indian clinical trial regulations

• Ethics Committees and Institutional Review Boards

• GCP principles and participant rights

Module 5: Clinical Trial Stakeholders and Responsibilities

• Sponsor responsibilities

• CRO functions and vendor management

• Principal Investigator and site-team responsibilities

• CRA, CRC, Medical Monitor, Data Manager and Pharmacovigilance roles

• Clinical trial team communication

Module 6: Clinical Trial Operations and Essential Documents

• Protocol design

• Informed Consent Forms

• Case Report Forms

• Trial Master File and Investigator Site File

• Pre-trial, during-trial and post-trial documents

• Clinical trial logs and documentation

Module 7: Study Start-Up and Site Initiation

• Site identification and feasibility

• Site Qualification and Site Initiation Visits

• Clinical trial supplies and IMP management

• Site Initiation Visit demonstration

Module 8: Clinical Trial Conduct and Site Management

• Participant recruitment and retention

• Screening, enrolment and randomization

• Visit schedules and source documentation

• Concomitant medications and prohibited therapy

• Protocol deviations and violations

Module 9: Clinical Data Management

• Clinical data management fundamentals

• CRF versus eCRF

• EDC systems

• Data entry and query management

• Data validation and data cleaning

• SDR, SDV and source-data review

• Database lock and analysis preparation

Module 10: Clinical Monitoring and Site Visits

• Types of monitoring visits

• Monitoring reports and follow-up letters

• Risk-Based Monitoring

• Risk-Based Quality Management

• Monitoring metrics and KPIs

Module 11: Safety and Pharmacovigilance

• Pharmacovigilance terminology

• Safety-reporting timelines

• Pharmacovigilance during clinical trials

• MedDRA overview and demonstration

• Adverse event management

Module 12: Hands-on Training with EDC Tools

• Clinical study design

• Electronic Case Report Form development

• Study visits and workflow

• Participant enrolment and data entry

• Data validation and edit checks

• Query management

• Monitoring and SDV

• Adverse event and medication entry

• Database review, lock and export

Module 13: Quality Assurance, Audits and Inspection Readiness

• Quality Management Systems

• Clinical trial audits

• FDA, EMA and CDSCO inspections

• CAPA and root-cause analysis

• Inspection readiness and documentation

Module 14: Clinical Trial Close-Out and Regulatory Submission

• Close-Out Visits

• Database lock and statistical-analysis preparation

• Clinical Study Reports

• NDA, BLA and MAA submissions

• Post-marketing surveillance

• Trial completion to drug approval

Module 15: Latest Trends and Advanced Clinical Research

• Decentralized Clinical Trials

• Virtual clinical trials and remote monitoring

• AI and machine learning in clinical trials

• Clinical research software and AI tools

• Wearables and digital biomarkers

• eConsent

• Precision medicine and genomics

• Adaptive trials

• AI-based clinical trial workflow demonstration

Module 16: Industry Readiness and Career Preparation

• Clinical research career paths

• Qualifications, skills and certifications

• Hiring and salary trends

• AI skills and future career pathways

• Resume building and professional networking

• Interview readiness and trial simulation

Tools, Documents and Practical Workflows

During the program, learners will be introduced to practical workflows involving:

• Castor EDC

• eCRF design

• Microsoft Excel

• Power BI

• SPSS, R or Python, where applicable

• ClinicalTrials.gov

• MedDRA

• ICH-GCP guidelines

• Protocol, ICF, CRF/eCRF, TMF and ISF

• QMS, CAPA and inspection-readiness documents

• Risk-Based Monitoring and RBQM

• Decentralized trial and AI-enabled workflows

Choose Your Applied Project Track

3-Month Applied Project Track

Best suited for focused skill-building, first portfolio development and role-specific practice.

Project options include:

1. Case Report Form Design and Data Entry

2. Clinical Operations Management Project

3. Regulatory Submission Package

4. Digital Clinical Trial Design

5. Clinical Trial Performance Dashboard Using Power BI

6. Full Randomized Controlled Trial Protocol

7. Impact of Diabetes on Quality of Life

8. Virtual Clinical Trial Protocol Design

6-Month Applied Project Track

Best suited for deeper operational, analytical, dashboard or clinical-data execution with expanded documentation.

Project options include:

1. Global Multicentre Clinical Trial Design

2. Clinical Trial Dashboard Development

3. Clinical Trial Data Visualisation and Analytics

4. Descriptive Analysis of a Clinical Dataset

5. Adverse Event Frequency Count

6. Treatment Group Comparison

7. Mini Clinical Trial Report

8. Public Clinical Trial Dataset Analysis

12-Month Applied Project Track

Best suited for end-to-end capstone specialization and the development of a comprehensive professional portfolio.

Project options include:

1. End-to-End Clinical Trial Simulation

2. End-to-End Clinical Data Management Using Castor EDC

3. AI-Enabled Decentralized Clinical Trial Design

Depending on the selected project, learners may develop practical outputs such as protocols, eCRFs, EDC databases, dashboards, monitoring reports, regulatory documents, risk plans, analytical reports and executive presentations.

Learning Outcomes

By completing the training and project work, learners will be able to:

• Understand the clinical trial life cycle from drug development to close-out

• Interpret essential clinical, regulatory, safety, quality and data-management documents

• Understand EDC and eCRF design workflows

• Apply data validation, query management and database-lock concepts

• Explain monitoring, RBM, RBQM, CAPA and inspection-readiness processes

• Understand decentralized and AI-enabled clinical trial workflows

• Develop a documented, industry-relevant project portfolio

• Prepare more confidently for clinical research interviews and entry-level opportunities

Who Can Enrol?

This program is suitable for:

• Life science graduates and postgraduates

• Biotechnology students and professionals

• Pharmacy graduates and postgraduates

• Medical, nursing and allied healthcare graduates

• Freshers seeking careers in clinical research

• Researchers and academicians

• Clinical research professionals seeking advanced operational or digital skills

• Professionals transitioning into clinical research, clinical data management, regulatory affairs, pharmacovigilance or quality roles

No prior clinical research experience is required. The program begins with foundational concepts before progressing to advanced applications.

Career Pathways

The skills covered in this program may support preparation for roles such as:

• Clinical Research Coordinator

• Clinical Trial Assistant

• Clinical Research Associate

• Clinical Data Coordinator

• Clinical Data Management Professional

• Clinical Operations Executive

• Regulatory Affairs Associate

• Pharmacovigilance or Drug Safety Associate

• Quality Assurance Professional

• Site Monitoring Professional

• Clinical Project Support

• Medical or Scientific Writer

Role eligibility and selection depend on the learner’s qualifications, experience, skills, performance, available openings and individual employer requirements.

What You Will Receive

Subject to successful completion, learners will receive:

• Advanced Clinical Research Training Certificate
• Applied Project Completion Certificate
• Work Experience Letter
• Industry Readiness and Placement Assistance
• Access to Session Recordings
• Mentored Project Guidance
• Resume and Interview Preparation Support

Your Learning Journey

1. Build Your Foundation: Learn clinical research terminology, drug development, trial phases, ethics and stakeholder roles.

2. Develop Operational Skills: Understand trial documents, study start-up, conduct, data, monitoring and safety workflows.

3. Explore Advanced Applications: Learn quality systems, regulatory submissions, EDC, decentralized trials and AI-enabled workflows.

4. Complete Applied Project Work: Select a 3, 6 or 12-month mentored project track.

5. Prepare for Career Opportunities: Build your portfolio, resume, professional profile and interview confidence.

Frequently Asked Questions

Is this program suitable for beginners?

Yes. The curriculum begins with clinical research fundamentals and gradually progresses to advanced operational, regulatory, data, quality and digital applications.

Can working professionals join?

Yes. Working professionals can use the advanced operations, EDC, regulatory, quality, monitoring, decentralized trial and AI modules to strengthen their existing skills.

What project-duration options are available?

Learners can choose a 3-month, 6-month or 12-month mentored applied project track.

Do I complete all the projects listed under a track?

The listed topics are available project options. The final project allocation and scope will depend on the selected track, academic background, mentor guidance and applicable program terms.

What practical exposure is included?

The program includes demonstrations, EDC/eCRF workflows, document-based activities, case studies, clinical trial simulations and guided applied projects.

Are AI topics included?

Yes. Dedicated sessions cover AI and machine learning in clinical trials, AI-supported recruitment, clinical research software and AI tools, AI-enabled decentralized trials and an AI-based clinical trial workflow demonstration.

What happens if I miss a live session?

Session recordings will be available through the assigned learning portal, subject to the applicable access terms.

Is placement assistance included?

Yes. Industry-readiness training and placement assistance are included. Final employment depends on qualifications, skills, performance, interview outcomes, available openings and employer requirements.

What credentials will I receive?

Upon successful completion, learners will receive a training certificate, project certificate and work experience letter, subject to the applicable completion requirements.

Whom can I contact for assistance?

For program-related queries, contact:

Email: cst@biotecnika.org or info@biotecnika.org
Phone: 1800-1200-1818

Take the Next Step in Clinical Research

Build practical skills, understand modern clinical trial workflows and create an industry-relevant project portfolio through structured training and mentored project work.

ADMISSIONS OPEN

100 Days Training | 100 Sessions | 3, 6 or 12-Month Project Work

REGISTER NOW