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Clinical Data Management

Results are only as reliable as the data behind them.

Why It Matters

We manage the full data lifecycle: eCRF design, validation, coding, query resolution and database lock, following CDISC standards and ALCOA+ data-integrity principles.

Who It Is for

Sponsors, CROs, academic investigators and research institutions.

See the service Brochure

What We Cover

eCRF design, data validation specifications and edit-check programming
Medical coding with MedDRA and WHO-DD
Query generation, discrepancy management and database lock
CDISC-aligned data handling and ALCOA+ data integrity

Benefits

Clean Data, Sooner

Edit checks designed with the protocol in mind.

Consistent Coding

MedDRA and WHO-DD applied to agreed conventions.

Audit-Ready

21 CFR Part 11 thinking across the lifecycle.

Smooth Lock

Planned reconciliation and lock activities.

Related Courses

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

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

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

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