Integrated Clinical Development for
CEBIS supports biologic and biosimilar clinical development with coordinated clinical operations, project management, regulatory, data, statistical, safety, quality and bioanalytical services.
Support can be structured around an individual study or coordinated across multiple stages and functions of the development program.
Support Across Different
Biologic development can require close coordination between clinical execution, scientific activities, safety oversight, data analysis and regulatory planning.
CEBIS can bring these functions together around the study objectives and development stage.
Early Clinical Development
Support for early clinical studies, pharmacokinetic requirements and other protocol-specific early-development needs.
Phase II–III Clinical Development
Project management, site management, monitoring, enrollment support, data delivery and cross-functional coordination for larger clinical programs.
Phase IV & Post-Marketing
Support for late-phase, observational and post-marketing studies designed to continue evidence generation after earlier development.
Coordinated Clinical
Trial Execution
Complex clinical programs depend on consistent study execution across sites, teams and supporting functions.
CEBIS can coordinate the operational activities required to move a study from planning through active conduct and closeout.
Project Management
Study planning, timelines, cross-functional coordination, issue management and sponsor communication.
Site Management
Coordination with participating sites throughout start-up, study conduct and closeout.
Clinical Monitoring
Site initiation, routine monitoring, risk-based monitoring and other study-specific oversight.
Patient Recruitment & Retention
Participant recruitment and engagement support based on the study population and site needs.
Clinical Supply Coordination
Support for study-material and supply requirements where needed by the program.
Clinical Data Connected
to Study Decisions
Clinical execution and study data need to remain aligned throughout development.
CEBIS can coordinate data-management and statistical activities with clinical operations so study information moves from collection and review through final analysis and reporting.
Data Management
Database setup, data review, cleaning, validation, reconciliation and preparation for database lock.
Biostatistics & Statistical Programming
Statistical planning, analysis and interpretation aligned with study objectives.
Medical Writing
Support for protocols, clinical study reports and other clinical or regulatory documents.
Safety Integrated
Throughout Study Delivery
Safety activities need to remain connected to clinical execution throughout the development program.
CEBIS can coordinate pharmacovigilance, medical oversight and safety-reporting activities with clinical operations, data and regulatory teams based on the needs of the study.
Support may include:
- Safety information review
- Medical oversight
- Pharmacovigilance activities
- Safety reporting coordination
- Clinical issue escalation
- Cross-functional communication with study teams
Analytical Support Where
the Program Requires It
Some biologic and biosimilar programs may require clinical and analytical activities to be closely coordinated.
CEBIS supports bioanalytical activities including method development, method validation, sample analysis and pharmacokinetic support.
Where appropriate to the study, these activities can be aligned with clinical execution, data management and statistical analysis.
One Function or Coordinated
Sponsors may require help with one specific study function or broader coordination across multiple areas of clinical development.
CEBIS can support individual services or bring clinical operations, regulatory, data, safety, medical writing, quality and other required functions together around the program.
Functional Support
Engage CEBIS for one defined need.
Integrated Delivery
Coordinate several study functions through a broader delivery model.
Multi-Site Programs
Support consistent study execution across participating centers.
International Programs
Coordinate activities across established markets and qualified delivery partners where appropriate.
Developing a Biologic or Biosimilar Program?
Tell us about the product, development stage, study objectives, countries and the support you require. A member of the CEBIS team can discuss the appropriate clinical-development approach.