Flexible Clinical Development Support for
CEBIS supports biotechnology companies with clinical development services that can be scaled around the program, from regulatory and study planning through clinical operations, data, statistics, safety, medical writing and study completion.
Sponsors can engage individual capabilities or coordinate multiple functions through one clinical-development partner.
Add the Capabilities the
Biotechnology development programs can require a changing mix of scientific, clinical, operational and regulatory support as they progress.
CEBIS can provide focused support where the sponsor already has internal expertise or coordinate several functions where additional development infrastructure is needed.
Focused Service
Engage one specific capability around an existing internal team.
Integrated Functions
Combine related operational, data, regulatory or safety services.
Broader Study Delivery
Coordinate multiple clinical-development functions around the study.
Clinical Support Across
Study Planning
Define the clinical study approach and required functions.
Regulatory & Start-Up
Coordinate documentation, regulatory and ethics activities.
Clinical Execution
Manage participating sites, monitoring, recruitment, supply and project delivery.
Data & Safety
Coordinate data management, statistical activities and safety oversight.
Study Completion
Support database completion, analysis, reporting and medical writing.
Specialist Functions Around One Clinical Program
Clinical Development — Phase I to IV
Support from early clinical development through later-phase and post-marketing research.
Clinical Operations
Project management, sites, monitoring, recruitment, supply and quality oversight.
Data, Technology & Analytics
Data management, biostatistics, statistical programming and clinical technology.
Regulatory, Medical Writing & Safety
Regulatory support, study documentation, pharmacovigilance and medical oversight.
Bioanalytical Services
Method development, validation and clinical-sample analysis where applicable.
Preclinical & Specialized Testing
Coordinated specialized testing where appropriate to the development program.
Support for Programs That Require Coordinated Expertise
Related pathways:
- Biologic & Biosimilar Clinical Development
- New Chemical Entity Studies
- Phase I & Early Clinical Development
- Regulatory Affairs
- Bioanalytical Services
Clear Responsibilities Across
Defined Responsibilities
Clarify which activities remain with the sponsor and which are managed by CEBIS.
Cross-Functional Coordination
Align the CEBIS functions involved in the study.
Milestone Visibility
Maintain focus on agreed study activities and timelines.
Issue Escalation
Surface operational questions requiring sponsor or clinical decisions.
- Biotechnology study examples
- Modality or product type
- Relevant therapeutic areas
- Study outcomes or approved case evidence
- Program phase
- Countries and sites
- CEBIS scope
Developing a Biotechnology Program?
Tell us about the product or modality, development stage, study objectives, countries and support you need. A member of the CEBIS team can discuss how the required functions can be aligned around the program.