Clinical Development Support in
Immunology
Clinical Functions
Immunology programs can differ widely based on the condition, mechanism, development phase, participant population and required assessments.
CEBIS can organize clinical-development services around the requirements of each study.
Planning
Translate the protocol into an operational and functional plan.
Sites
Identify and prepare appropriate participating sites.
Recruitment
Coordinate participant recruitment and screening.
Clinical Execution
Manage monitoring, site activity and project coordination.
Data & Statistics
Collect, review and analyze clinical-study information.
Safety & Reporting
Coordinate safety activities, medical oversight and study documentation.
Specialist Functions Around the Immunology Study
Sponsors can use these functions individually or coordinate multiple capabilities around the wider clinical program.
Clinical Trial & Project Management
Site Management & Monitoring
Patient Recruitment, Retention & Adherence
Clinical Supply & Logistics
Data Management
Biostatistics & Statistical Programming
Regulatory Affairs
Medical Writing
Pharmacovigilance
Medical Monitoring
Quality Oversight
Finding the Appropriate Sites and Study Population
Site and recruitment strategy should be based on the individual immunologic condition, eligibility criteria, specialist requirements and expected patient pathway.
CEBIS can support:
Feasibility
Assess the operational requirements of the protocol.
Site Identification
Identify potential sites relevant to the target population.
Start-Up
Coordinate preparation for study initiation.
Recruitment
Develop appropriate participant-identification approaches.
Monitoring
Provide oversight during active study conduct.
Retention
Support communication and continued participation.
From Study Data to Analysis and Reporting
Data-management and statistical activities can be integrated throughout the immunology study.
Study Build
Data Collection
Validation & Cleaning
Reconciliation
Database Lock
Analysis
Reporting
CEBIS can coordinate these activities with clinical operations and medical writing so study information moves consistently from participating sites toward final outputs.
Safety Processes Connected to Clinical Study Conduct
CEBIS can coordinate clinical operations with Pharmacovigilance and Medical Monitoring throughout study delivery.
Relevant activities can include:
Support Based on the Program and Development Stage
Relevant service pathways can include:
CEBIS Immunology Experience
Planning an Immunology Clinical Study?
Tell us about the indication, product, development stage, study design, patient population, countries and support you require.