Full-Service Clinical Development
CEBIS supports clinical development programs from early-stage studies through Phase II–III, late-phase and post-marketing research. Clinical operations, project management, regulatory, data, statistical, safety, medical writing and supporting services can be coordinated around the needs of each program.
Support Across
CEBIS brings together clinical strategy, operational execution, data delivery, regulatory support and safety oversight to support sponsors at different stages of development.
Phase I & Early Development
Early clinical development support for pharmacokinetic studies, healthy-volunteer and patient studies, first-in-human programs and other specialized early-phase requirements.
Phase II–III Clinical Development
Full-service clinical trial strategy, project management, site oversight, monitoring, enrollment support, data delivery and cross-functional study coordination.
Phase IV, Late-Phase & Post-Marketing
Support for late-phase, observational and post-marketing studies designed to continue generating safety, outcomes and clinical-use evidence.
Real-World Evidence & Observational Research
Observational and real-world evidence programs designed to answer clinical questions using information generated in routine practice and broader patient settings.
Clinical Development
Study requirements vary by development stage, product and research question. CEBIS provides focused development pathways that can be used individually or combined within a broader clinical program.
Full-Service Clinical Trial Management — Phase I to IV
Coordinated clinical trial support from study planning and start-up through project management, monitoring, data delivery and closeout.
Phase I & Early Clinical Development
Early clinical, pharmacokinetic, healthy-volunteer, patient and specialized study support.
Phase II–III Clinical Development
Operational execution and cross-functional support for multi-site Phase II and Phase III clinical trials.
Phase IV, Late-Phase & Post-Marketing Studies
Late-phase and post-approval research supporting continued evidence generation.
Real-World Evidence & Observational Research
Observational studies designed to generate evidence in broader clinical and real-world settings.
New Chemical Entity Studies
Clinical, pharmacokinetic, analytical, data and regulatory support for new chemical entity programs.
Biologic & Biosimilar Clinical Development
Integrated clinical development support for biologic and biosimilar programs across relevant stages of development.
505(b)(2) Clinical Development
Clinical and regulatory support for 505(b)(2) programs, including relevant clinical, PK, BA/BE and bioanalytical activities.
One Program.
Coordinated Study Support.
CEBIS can coordinate the clinical and supporting functions required to move a study from planning through execution, analysis and closeout. Clinical operations, regulatory affairs, data management, biostatistics, pharmacovigilance, medical oversight and medical writing can be aligned around the same study plan, timelines and development objectives.
This integrated approach helps reduce fragmented handoffs between functions and gives sponsors clearer visibility across the program. Responsibilities, milestones, study issues and key deliverables can be coordinated across teams so that each function supports the wider clinical-development strategy rather than operating in isolation.
Clinical Operations & Project Management
Study leadership, site management, monitoring, enrollment oversight and operational coordination.
Regulatory Affairs
Support for regulatory activities, ethics requirements, study start-up and ongoing regulatory needs.
Data Management & Biostatistics
Database development, data review and cleaning, statistical analysis and study outputs.
Pharmacovigilance & Medical Oversight
Safety surveillance, medical review, safety reporting and ongoing clinical oversight.
Medical Writing
Support for protocols, study reports and other clinical and regulatory documents.
Quality Assurance
Quality oversight, risk-based review, audit and inspection support throughout study delivery.
Support for a Range of
Clinical development requirements can differ by product type and development strategy. CEBIS brings together the clinical, regulatory, data, safety and operational functions needed to support different program needs.
Small Molecules
Clinical development support across early, mid-stage and late-phase programs.
Large Molecules
Coordinated clinical and supporting services based on the needs of the program.
Biologics
Integrated clinical, regulatory, safety, data and operational support.
Biosimilars
Clinical and bioanalytical support aligned with the development program and study requirements.
Planning a Clinical Development Program?
Tell us about your product, development stage, study design, countries and the support you require. A member of the CEBIS team will discuss the appropriate next steps with you.