100 Days Advanced Clinical Research Training Program With 3, 6 & 12-Month Applied Project Tracks + Diploma Option + Placement Assistance

ADVANCED CLINICAL RESEARCH TRAINING + Advanced Professional Diploma in Clinical Research & Trial Operations 2026 Featuring Dedicated AI Modules in Clinical Research 100 Days LIVE Training | 100 Sessions | 16 Advanced Modules | APPLIED PROJECT WORK | DIPLOMA OPTION Choose 3, 6 or 12 Months of Mentored Applied Project Work Earn an Advanced Professional Diploma with the 12-Month Project Track Complete the 100-day training, 12-month applied project work and an exclusive 12-session Clinical Research Real-World Skill Booster Module to earn an Advanced Professional Diploma in Clinical Research & Trial Operations from BioTecNika. Beginner-Friendly • Advanced Learning • Practical Workflows • Applied Project Work Placement Assistance | Training Certificate | Project Certificate | Work Experience Letter | Advanced Professional Diploma with 12-Month Track issued by Biotecnika STARTS 24th 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 + Exclusive 12-Session Skill Booster Module for Diploma Learners 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: 24th SEP 2026 Class Timing: 7:30 - 8:30 PM IST Diploma Eligibility: Available exclusively with the 12-month applied project track, subject to successful completion of the training, project work, Skill Booster Module and applicable assessments Credentials: Training Certificate and Project Certificate; Work Experience Letter with the 6 and 12-month tracks; Advanced Professional Diploma with the 12-month track 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 Diploma Track: End-to-end capstone specialization, comprehensive professional portfolio, exclusive Clinical Research Real-World Skill Booster Module and an Advanced Professional Diploma upon successful completion. 6. Advanced Professional Diploma with the 12-Month Track Learners opting for the 12-month project track will follow an extended professional learning pathway that includes the 100-day advanced training, mentored project work and an exclusive 12-session Clinical Research Real-World Skill Booster Module. Upon successful completion of all requirements, learners will receive an Advanced Professional Diploma in Clinical Research & Trial Operations from BioTecNika. 7. 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 Exclusive Diploma Module: Clinical Research Real-World Skill Booster Exclusive to learners enrolled in the 12-Month Diploma Track Total Sessions: 12 Duration: 90 Minutes Per Session Schedule: This module will begin after learners have completed the initial phase of their 12-month project work. 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: Case Report Form Design and Data Entry Clinical Operations Management Project Regulatory Submission Package Digital Clinical Trial Design Clinical Trial Performance Dashboard Using Power BI Full Randomized Controlled Trial Protocol Impact of Diabetes on Quality of Life 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: Global Multicentre Clinical Trial Design Clinical Trial Dashboard Development Clinical Trial Data Visualisation and Analytics Descriptive Analysis of a Clinical Dataset Adverse Event Frequency Count Treatment Group Comparison Mini Clinical Trial Report Public Clinical Trial Dataset Analysis 12-Month Applied Project + Advanced Professional Diploma Track Our most comprehensive learning pathway, designed for learners seeking end-to-end clinical research exposure, an advanced capstone specialization and a strong professional portfolio. This track includes the exclusive 12-session Clinical Research Real-World Skill Booster Module. Project options include: End-to-End Clinical Trial Simulation End-to-End Clinical Data Management Using Castor EDC AI-Enabled Decentralized Clinical Trial Design Diploma Award Upon successfully completing the 100-day training, 12-month applied project work, Skill Booster Module, required activities and assessments, learners will receive an Advanced Professional Diploma in Clinical Research & Trial Operations from BioTecNika. 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 The current section makes it appear that everyone receives all credentials. A track-wise table would be clearer: Credential/Benefit 3 Months 6 Months 12-Month Diploma Track Advanced Clinical Research Training Certificate ✓ ✓ ✓ Applied Project Completion Certificate ✓ ✓ ✓ Work Experience Letter — ✓ ✓ Letter of Recommendation — — ✓ Clinical Research Real-World Skill Booster — — ✓ Advanced Professional Diploma — — ✓ Placement Assistance ✓ ✓ ✓ Your Learning Journey Build Your Foundation: Learn clinical research terminology, drug development, trial phases, ethics and stakeholder roles. Develop Operational Skills: Understand trial documents, study start-up, conduct, data, monitoring and safety workflows. Explore Advanced Applications: Learn quality systems, regulatory submissions, EDC, decentralized trials and AI-enabled workflows. Complete Applied Project Work: Select a 3, 6 or 12-month mentored project track. 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. Who is eligible for the Advanced Professional Diploma? The Advanced Professional Diploma is exclusively available to learners opting for the 12-month project track. Learners must successfully complete the 100-day training, 12-month applied project work, exclusive Skill Booster Module and prescribed assessments. Will learners opting for three or six months receive the Diploma? No. Learners enrolled in the three or six-month tracks will receive the applicable training and project credentials. The Advanced Professional Diploma is reserved exclusively for the 12-month track. Who issues the Diploma? The Advanced Professional Diploma in Clinical Research & Trial Operations is issued by BioTecNika upon successful completion of the prescribed professional training and project requirements. 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 Tracks | Advanced Professional Diploma with 12-Month Track REGISTER NOW