Clinical Development Support
CEBIS supports new chemical entity programs with coordinated early clinical, pharmacokinetic, bioanalytical, data, statistical, regulatory and safety services.
Support can be structured around a specific study or combined across multiple early-development functions.
Building the Evidence Needed
for the Next Development Step
Study Designs Based
Depending on the product and development plan, support can include:
First-in-Human Studies
Early clinical studies designed to generate initial information on human exposure, safety and tolerability.
Single Ascending Dose Studies
Studies evaluating increasing single doses and early pharmacokinetic behavior.
Multiple Ascending Dose Studies
Studies evaluating repeated dosing, tolerability and pharmacokinetics over multiple administrations.
Pharmacokinetic Studies
Studies designed to evaluate drug exposure and other pharmacokinetic characteristics.
PK/PD Studies
Programs connecting pharmacokinetic information with relevant pharmacodynamic measures.
Patient Population Studies
Early clinical studies conducted in defined patient populations when required by the product or study objective.
Methods and Sample Analysis
Supporting Early Clinical Studies
Method Development
Development of analytical methods based on the compound, matrix and study requirements.
Method Validation
Validation activities designed to confirm that the method is appropriate for the intended study use.
Sample Analysis
Analysis of clinical samples generated during the study.
Pharmacokinetic Support
Connection of analytical results with pharmacokinetic evaluation and study data.
One Early-Development
Workflow
An early clinical program may involve clinical execution, sample collection, bioanalysis, data management and statistical analysis at the same time.
CEBIS can coordinate these activities around the protocol and study timeline so information moves from the clinical study through analysis and reporting.
Clinical Operations
Study planning, participant activities and operational execution.
Bioanalysis
Method development, validation and sample analysis.
Data Management
Study data collection, review, cleaning and preparation.
Pharmacokinetics & Biostatistics
Evaluation and analysis of study data.
Safety & Medical Oversight
Clinical and safety review throughout study conduct.
Medical Writing
Study documentation and final reporting support.
Supporting the Next Stage
The value of an early NCE study is not simply completing the protocol. The resulting clinical, pharmacokinetic, analytical and safety data should help inform the next development decision.
CEBIS can coordinate data management, statistical analysis and study reporting with the clinical and bioanalytical work so study outputs are organized for continued development.
Phase I & Early Clinical Development
Broader early clinical support for FIH, SAD/MAD, PK/PD, healthy-volunteer and patient studies.
Bioanalytical Services
Method development, validation, sample analysis and pharmacokinetic support.
BA/BE & Pharmacokinetic Studies
Clinical and analytical support for bioavailability, bioequivalence and other PK-focused study requirements.
Planning an NCE Development Program?
Tell us about the molecule, current development stage, proposed study design, population, bioanalytical requirements and timeline. A member of the CEBIS team can discuss the appropriate clinical-development support.