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Clinical Research Courses for Real Roles

17 live online programmes, from a one-weekend GCP refresher to our flagship ACCRO-DLS certificate. Each course is taught by practitioners from our network of 14,000+ industry professionals.

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Flagship · next batch 12 Dec

Clinical research & operations

ACCRO-DLS: Advanced Certificate in Clinical Research Operations & Data Life Science

Our complete programme: trial operations, data management, drug safety, statistics, writing and career preparation in one cohort.

48 live hours · 8 weekends
Live online with recordings · Next batch: 12 Dec 2026
B.Pharm, M.Pharm, Pharm.D, life sciences, MBBS/BDS/AYUSH, nursing, health-IT

What you will learn

Clinical research operations & site start-up
Clinical data management & medical coding
Pharmacovigilance & drug safety
Biostatistics, evidence synthesis & medical writing
Regulatory affairs, QA, AI and medical devices overview
ATS resume, mock interviews & placement assistance

Full details

High demand

Clinical research & operations

Clinical Research Associate & Coordinator (CRA/CRC)

Run and monitor a study site: feasibility, consent, visits, source documents, SDV and site files.

6 weekends
Live online with recordings · Next batch: on request
Pharmacy, life sciences, nursing and medical graduates

What you will learn

ICH-GCP E6(R3), NDCT Rules 2019 & ICMR ethics
Feasibility, SQV, SIV and close-out visits
Informed consent process & documentation
Source data verification & monitoring reports
ISF/eTMF, IP accountability and SAE reporting

Short course

Clinical research & operations

GCP Essentials: ICH E6(R3), NDCT Rules & ICMR Ethics

A focused refresher on current Good Clinical Practice for students, faculty and site staff.

1 weekend
Live online with recordings · Next batch: on request
Students, faculty, investigators and site staff

What you will learn

The ICH-GCP principles in practice
Roles of sponsor, investigator and ethics committee
NDCT Rules 2019 essentials
ICMR National Ethical Guidelines
Case-based assessment

High demand

Drug safety

Pharmacovigilance & Drug Safety Operations

Case processing from intake to narrative: triage, MedDRA coding, causality and reporting timelines.

6 weekends
Live online with recordings · Next batch: on request
Pharmacy, life sciences and medical graduates

What you will learn

ICSR intake and the four validity criteria
Seriousness, expectedness and triage
MedDRA coding and causality (WHO-UMC, Naranjo)
Safety narrative writing
Expedited reporting timelines, PSUR/PBRER overview and PvPI

High demand

Data, statistics & AI

Clinical Data Management (CDM)

The full data lifecycle: CRF design, edit checks, discrepancy management, coding and database lock.

6 weekends
Live online with recordings · Next batch: on request
Pharmacy, life sciences and health-IT graduates

What you will learn

EDC systems and eCRF design
Data validation specifications and edit checks
Query and discrepancy management
Medical coding with MedDRA and WHO-DD
21 CFR Part 11, audit trails and database lock
CDISC CDASH/SDTM overview

Data, statistics & AI

Biostatistics for Clinical & Health Research

Study design, sample size and analysis you can defend, using SPSS, GraphPad Prism and R.

6 weekends
Live online with recordings · Next batch: on request
Postgraduates, PhD scholars, faculty and data aspirants

What you will learn

Study designs and hypothesis testing
Sample size and power
Choosing the right test
Regression and survival analysis basics
Systematic reviews and meta-analysis (PRISMA)

Data, statistics & AI

Clinical Data Analytics: Excel, SQL, R & Python

Clean, query, summarise and visualise clinical study data with the tools teams use daily.

6 weekends
Live online with recordings · Next batch: on request
Graduates moving into data roles

What you will learn

Excel for clinical data
SQL for querying study data
R and Python basics for analysis
Tables, listings and figures
Dashboards for trial metrics

Future ready

Data, statistics & AI

AI in Clinical Research

How AI is used across trials today, and how to use it responsibly and compliantly in your own work.

3 weekends
Live online with recordings · Next batch: on request
Students and working professionals

What you will learn

Where AI fits in the trial lifecycle
AI for literature review, writing and data review
Prompting for regulated work
Validation, data privacy and GxP considerations
Hands-on mini project

Regulatory, quality & writing

Medical & Scientific Writing

Write the documents trials depend on: protocols, CSRs, safety narratives, manuscripts and reviews.

5 weekends
Live online with recordings · Next batch: on request
Pharmacy, life sciences and medical graduates

What you will learn

Protocol synopsis and ICF writing
Clinical study reports (ICH E3)
Safety narratives
Manuscripts, case reports and literature reviews
Referencing and plagiarism checks

Regulatory, quality & writing

Medical Coding: MedDRA, WHO-DD & ICD-10

Code adverse events, medications and diagnoses accurately for trials, safety and healthcare.

4 weekends
Live online with recordings · Next batch: on request
Pharmacy, life sciences, nursing and medical graduates

What you will learn

MedDRA hierarchy from SOC to LLT
WHO Drug Global coding
ICD-10-CM fundamentals
Coding conventions and quality checks
Practice on real-format cases

Regulatory, quality & writing

Regulatory Affairs in Clinical Research

Approvals and submissions for trials in India and abroad: CDSCO, SUGAM, CTRI, ethics and global agencies.

5 weekends
Live online with recordings · Next batch: on request
Pharmacy and life sciences graduates

What you will learn

NDCT Rules 2019 and CDSCO pathways
SUGAM portal and CTRI registration
Ethics committee submissions
US FDA, EMA and ICH overview
Regulatory documents and dossiers

Regulatory, quality & writing

Quality Assurance in Clinical Research

Keep trials inspection-ready: SOPs, audits, CAPA, deviations and data integrity.

4 weekends
Live online with recordings · Next batch: on request
Graduates and site/CRO staff

What you will learn

GCP quality systems and SOPs
Site, vendor and TMF audits
Deviations and CAPA
ALCOA+ and data integrity
Inspection readiness

Devices & bioanalytical

Medical Devices: Clinical Investigation & Regulation

How device studies differ from drug trials, under ISO 14155 and India’s Medical Devices Rules 2017.

4 weekends
Live online with recordings · Next batch: on request
Pharmacy, biomedical engineering and life sciences graduates

What you will learn

Device classification and risk
Medical Devices Rules 2017
ISO 14155 clinical investigations
Post-market surveillance and materiovigilance
EU MDR and US FDA overview

Devices & bioanalytical

Bioanalytical & BA/BE Studies

The science and compliance behind bioavailability and bioequivalence studies and their lab analysis.

4 weekends
Live online with recordings · Next batch: on request
Pharmacy (pharmaceutics, analysis) and life sciences graduates

What you will learn

BA/BE study design
Clinical conduct of BE studies
Bioanalytical method validation basics
Pharmacokinetic parameters
CDSCO BE guidance and documentation

Most complete

Clinical research & operations

Professional Diploma in Clinical Research, Data Management & Drug Safety

Clinical operations, CDM and pharmacovigilance with biostatistics basics, a capstone project and career preparation.

4 months · weekends
Live online with recordings · Next batch: on request
Graduates who want an in-depth, job-focused programme

What you will learn

Clinical operations and GCP
Clinical data management
Pharmacovigilance
Biostatistics basics
Capstone project
Resume, LinkedIn and mock interviews

New

Career & business

Business Development & Strategic Management in Clinical Research and Pharma

The commercial side of research: proposals, budgets, sponsor relations, partnerships and growth strategy.

6 weekends
Live online with recordings · Next batch: on request
Pharma MBA students, life-science graduates and professionals moving into business roles

What you will learn

How sponsors, CROs, SMOs and sites do business
RFIs, RFPs and proposal writing
Trial budgeting and costing
CDA, CTA and MSA essentials
Pharma market research and competitor analysis
Partnerships, KPIs and growth planning

Full details

New

Career & business

Professional Development & Career Excellence

From qualified to job-ready: ATS resume, LinkedIn, interview practice and placement assistance.

4 weekends
Live online with recordings · Next batch: on request
Final-year students, fresh graduates and career switchers

What you will learn

Clinical research and pharma career map
ATS-friendly resume and LinkedIn profile
Technical and HR mock interviews
Professional communication and GCP mindset
Placement assistance and job-search plan

Full details

Don’t see the course you need? We run focused batches on request for individuals, groups and colleges. Tell us the topic and we will plan it with an expert from our network.

Clinovitas programmes are professional skill-training certifications awarded by Clinovitas Life Sciences. They are not university degrees or diplomas. Course content and schedules may change.

Brochure

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Courses, the ACCRO-DLS curriculum, services, founders and how to join. Download it, or share it with friends, faculty and your college.

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