DATA MANAGEMENT

Clinical Data Management from

Study Build Through Database Lock

CEBIS supports clinical studies with data-management services designed to help collect, review, clean, reconcile and prepare study data for statistical analysis and reporting.

Data activities can be coordinated with clinical operations, biostatistics, safety and clinical technology throughout the study.

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DATA LIFECYCLE

A Structured Approach from
Start-Up to Final Data

CEBIS supports clinical data management from study build and planning through data cleaning, database lock, export and archiving.

Prepare study-specific data structures around the protocol and visit schedule.

Define how study data will be collected, reviewed, cleaned and prepared for final use.

Capture information through study CRFs/eCRFs and related data sources.

Identify missing, inconsistent or potentially incorrect information and coordinate resolution.

Align relevant clinical, safety and laboratory data where required.

Complete final review and prepare the cleaned database for analysis.

Prepare appropriate study-data outputs and archival materials.

STUDY SET-UP

Data Structures Built
Around the Protocol

Data-management work begins before participant information starts entering the study database.

Study build can include study-specific database development, visit structures, workflow configuration, version control and testing before data collection begins.

Support can include:

  • Study database setup
  • Study visit structures
  • Data-entry workflows
  • Study-specific configuration
  • Database testing
  • Version control
  • Validation activities
DATA COLLECTION

Capturing the Data

the Study Actually Needs
Well-designed case report forms help teams collect information consistently and reduce downstream cleaning. CEBIS supports eCRF creation, CRF libraries, study-specific data-entry guidance and programmed validation checks.

CRF / eCRF Design

Develop forms around the protocol and required study information.

Edit Checks

Apply programmed checks to identify incomplete or inconsistent data.

Data-Entry Guidance

Provide clear instructions for entering study information.

Validation

Support structured review of captured data as the study progresses.

DATA QUALITY

Keeping Study Data
Complete and Consistent

Clinical data needs ongoing review while the study is active.

CEBIS can support identification and resolution of missing, inconsistent or questionable study information before the database moves toward final lock.

Key activities can include:

  • Data review
  • Discrepancy identification
  • Query generation and follow-up
  • Data cleaning
  • Data validation
  • Site-data follow-up
  • Documentation of resolved items
DATA RECONCILIATION

Connecting Data

Across Study Functions
Some study information must be reconciled across systems and functional teams. CEBIS data-management support includes SAE reconciliation and laboratory-data management.

SAE Reconciliation

Coordinate comparison of relevant clinical and safety information where required.

Laboratory Data

Support handling and review of laboratory reference ranges and study laboratory information.

Cross-Functional Review

Work with clinical, safety and other study teams to resolve outstanding data differences.

CEBIS services graphic
STUDY COMPLETION

Preparing Clean

Data for Final Analysis
Before final statistical analysis, the database must reach a controlled final state. CEBIS supports database lock, final data export and archiving as part of study closeout.
Explore Biostatistics & Statistical Programming
01

Final Review

Confirm outstanding data issues have been addressed.

02

Database Lock

Complete the agreed lock process once the study data is ready.

03

Data Export

Prepare required study-data outputs for downstream analysis.

04

Archive

Retain appropriate study-data materials according to the agreed process.

INTEGRATED DELIVERY

Data Management
Does Not Work in Isolation

Data-management activities need to remain connected to the people generating, reviewing and analyzing the study information.

CEBIS can coordinate Data Management with:

  • Clinical Operations
  • EDC / eCRF
  • Medical Monitoring
  • Statistical Programming
  • Site Management & Monitoring
  • Pharmacovigilance
  • Biostatistics
  • Medical Writing

Need Data Management Support for Your Clinical Study?

Tell us about your protocol, study phase, data sources, sites, systems and expected timeline. A member of the CEBIS team can discuss the appropriate data-management approach.

Discuss Your Data Needs
Request a Proposal