EDC, IRT & CLINICAL TECHNOLOGY

Clinical Technology Supporting Data

Capture, Randomization and Study Delivery

CEBIS supports clinical studies with technology capabilities for electronic data capture, eCRF management, randomization, subject and site management, clinical supply coordination and broader study administration.

Technology can be integrated with data management and clinical operations based on the requirements of the study.

CONNECTED TECHNOLOGY

Systems Supporting

the Clinical Workflow
CEBIS supports clinical-study technology across data capture, randomization, site and subject management, clinical supply coordination and study administration.

EDC & eCRF

Support structured electronic collection and review of study data.

IRT / IWRS

Support randomization, participant status and investigational-product supply requirements.

Study Administration

Support site, user and study information used during trial delivery.

Study Planning & Analytics

Use study and performance information to support planning and oversight where applicable.

EDC & ECRF

Structured Electronic
Study Data Collection

EDC/eCRF support can include study-database configuration, CRF creation, programmed edit checks, real-time validation and extraction of standardized clinical data.
Capabilities include:

Set up study-specific databases based on protocol requirements.

Create electronic case report forms for structured collection of study data.

Use programmed checks to identify missing or inconsistent information.

Apply real-time review rules during study data entry.

Support review of critical study data against source information.

Prepare study data for review and downstream use.

IRT & RANDOMIZATION

Participant Randomization and
Study Supply Coordination

IRT/IWRS support can connect randomization with subject management, site management and investigational-product supply.

Support assignment approaches based on the study design.

Track participant activities from screening and enrollment through completion or withdrawal.

Maintain participating-site information and study status.

Connect study activity with investigational-product supply requirements.

Support controlled study processes where unblinding functionality is required.

STUDY OPERATIONS

Technology Supporting Participants and Sites

Operational IRT support can cover subject screening and enrollment, visit status, site activation, investigational-product dispensing and receipt, and subject withdrawal or completion.

Participant Journey

Screening

Enrollment

Study Visits

Completion

Site Journey

Registration

Activation

Active Study Conduct

Closeout

STUDY ADMINISTRATION

Managing Study Users,
Resources and Core Information

Clinical trial management technology can centralize study information, support reusable master data and provide role-based access for study teams.

Relevant capabilities can include:

PLANNING & ANALYTICS

Using Study Information

to Support Planning
Historical CRO, site and investigator performance information can support clinical-trial planning and decision-making.

Historical Study Information

Review available study or performance information where appropriate.

 

Planning Support

Use relevant information to support study-planning decisions.

Site & Investigator Review

Compare available operational information when evaluating sites and investigators.

Study Oversight

Present relevant information through structured dashboards or reports where available.

INTEGRATED DELIVERY

Technology Supporting the
People Running the Study

Clinical technology is most useful when it supports the wider study rather than becoming a separate workstream.

CEBIS can connect clinical technology with:

Need EDC, IRT or Clinical Technology Support?

Tell us about your study design, sites, randomization requirements, data-capture needs and existing systems. A member of the CEBIS team can discuss the appropriate technology approach.