PHASE IV & LATE-PHASE RESEARCH
Late-Phase and Post-Marketing Research
for Continued Evidence Generation
CEBIS supports Phase IV, late-phase and post-marketing studies designed to continue generating clinical evidence after earlier stages of development.
Our teams can coordinate clinical operations, observational research, data management, biostatistics, safety, medical writing and supporting services around the objectives of the program.
LATE-PHASE DEVELOPMENT
Understanding a
Product in Broader Clinical Use
Earlier clinical trials answer important questions within defined study populations and controlled protocols. Late-phase and post-marketing research can continue that evidence generation in broader patient populations and routine clinical settings.
Observational studies can collect information from standard clinical practice to help understand outcomes and treatment use in real-world settings.
Late-phase research can be designed around questions related to:
- Safety
- Clinical outcomes
- Product use in routine practice
- Broader patient populations
- Longer-term follow-up
- Uncommon or less frequently observed events
- Additional evidence needs after earlier development
STUDY TYPES
Flexible Approaches
to Post-Approval Evidence
01
Phase IV Clinical Studies
Continued clinical research following earlier development, designed around defined post-approval questions and study objectives.
02
Post-Marketing Observational Studies
Studies collecting information from standard clinical practice to better understand product use, safety and outcomes in broader patient settings.
03
Real-World Evidence Studies
Evidence-generation programs designed around information produced in routine clinical care and real-world settings.
04
Safety Follow-Up
Studies or programs focused on continued evaluation of safety information after broader product use.
05
Outcomes Research
Research designed to understand clinical outcomes and other relevant measures within the target population.
06
Retrospective Research
Where appropriate, existing clinical information can be reviewed retrospectively to investigate defined questions, including uncommon events that may be difficult to study prospectively.
STUDY DELIVERY
Operational Support Built
Around the Research Question
Late-phase studies may be less controlled than traditional interventional trials, but they still require clear study planning, site coordination, data collection and oversight.
CEBIS can coordinate the operational activities required to deliver the study based on its design and scope.
Project Management
Study planning, timelines, responsibilities, site coordination and communication across participating teams.
Site Management
Support for participating sites and study teams throughout start-up, data collection and closeout.
Participant Coordination
Support for participant communication, retention and study-related follow-up where required by the protocol.
Data Management
Structured collection, review, cleaning and preparation of study data.
Biostatistics
Statistical analysis and interpretation aligned with the research objectives.
Safety Support
Coordination of relevant safety activities throughout the program.
EVIDENCE GENERATION
Turning Clinical Information
Into Usable Evidence
The value of a late-phase program depends on collecting information in a structured way and connecting it to the study question.
CEBIS can align clinical operations, data management and statistical analysis so information collected from participating sites and patients can be reviewed and interpreted as part of the wider evidence program.
POST-MARKETING SAFETY
Continued Attention
to Safety After Earlier Development
Post-marketing research can provide additional information as a product is used across broader populations and clinical settings.
CEBIS can connect late-phase study delivery with pharmacovigilance, medical review and safety-reporting activities based on the needs of the program.
STILL DEFINING YOUR PROGRAM?
Planning a Phase IV or Post-Marketing Study?
Tell us about the product, research question, patient population, countries and evidence you need to generate. A member of the CEBIS team can discuss the appropriate late-phase study approach.