Clinical Development Support
CEBIS supports clinical and supporting activities for 505(b)(2) development programs, with services that can include clinical study execution, pharmacokinetic studies, BA/BE support, bioanalysis, data, statistics, regulatory support and medical writing.
Services can be selected based on the development plan and evidence required for the program.
Study Support Based on
the Development Question
505(b)(2) programs can require a focused combination of clinical, pharmacokinetic, analytical and regulatory activities.
Rather than treating each activity separately, CEBIS can coordinate the required study functions around the product, development strategy and study objectives.
Clinical Studies Designed Around
Depending on the development plan, relevant support can include:
Pharmacokinetic Studies
Clinical studies designed to evaluate drug exposure and other pharmacokinetic characteristics.
BA/BE Studies
Bioavailability or bioequivalence studies where they form part of the required development program.
Food-Effect Studies
Fasting and fed study designs where food effect needs to be evaluated.
Drug Interaction Studies
Drug-drug interaction studies where required by the clinical-development strategy.
Healthy Volunteer Studies
Clinical or PK studies in healthy participants where appropriate.
Patient Population Studies
Studies in defined patient populations when required by the product or research question.
Connecting the Clinical
Study With Analytical Data
Depending on the program, pharmacokinetic or BA/BE activities may need to be coordinated with bioanalytical sample analysis.
CEBIS can connect protocol design, clinical execution, analytical quantification, pharmacokinetic analysis, biostatistics and study reporting within one development program.
Relevant Bioanalytical Support:
- Method development
- Method validation
- Sample analysis
- Pharmacokinetic support
- BA/BE study support
- Sample storage where applicable
Clinical Development
Connected to Regulatory Activities
Clinical-study activities need to remain aligned with the broader regulatory plan for the product.
CEBIS can coordinate regulatory and ethics activities with study execution, data management, statistical analysis and medical writing.
Relevant support can include:
- Regulatory planning
- Clinical trial applications
- Ethics / IRB activities
- Study amendments
- Protocol and study-document support
- Clinical data and statistical outputs
- Medical writing and study-report support
Clinical, Analytical and
Regulatory Activities Working Together
505(b)(2) development can involve several connected workstreams.
CEBIS can coordinate the functions needed for the program rather than requiring sponsors to manage each activity independently.
Clinical Operations
Study planning and execution.
Bioanalytical Services
Method development, validation and sample analysis.
Data & Biostatistics
Data management, pharmacokinetic analysis and statistical support.
Regulatory Affairs
Regulatory coordination throughout development.
Medical Writing
Clinical and regulatory documentation.
Quality
Quality-focused oversight across study activities.
Planning a 505(b)(2) Development Program?
Tell us about the product, current development stage, proposed studies and clinical or analytical requirements. A member of the CEBIS team can discuss the appropriate support for your program.