HEALTHY VOLUNTEER & PATIENT STUDIES

Clinical Study Support Built

Around the Participant Population

CEBIS supports clinical and pharmacokinetic studies in healthy volunteers and defined patient populations, with study activities planned around eligibility requirements, participant safety, study visits, recruitment and data needs.

STUDY POPULATIONS

The Right Population for the

Study Question

Participant requirements depend on the product, study design and development question. CEBIS supports studies in healthy participants as well as patient-population PK/PD and clinical-endpoint bioequivalence studies.

Healthy Volunteer Studies

Support for BA/BE, pharmacokinetic and other early clinical studies in healthy participants where appropriate.

Patient Population Studies

Support for clinical or PK/PD studies requiring participants with a defined disease or condition.

Protocol-Specific Populations

Support for defined participant groups where the study requires specific demographic or clinical characteristics.

HEALTHY PARTICIPANTS

Support for PK, BA/BE and Early Clinical Studies

Healthy-volunteer studies may include fasting or fed designs, pharmacokinetic or pharmacodynamic assessments, and studies in postmenopausal healthy participants when appropriate to the protocol.

Study support may include:

Participant screening
Eligibility confirmation
Study visits
Dosing activities
Clinical observations
Sample collection
Participant communication
Study completion and follow-up

PATIENT STUDIES

Clinical Studies Requiring Disease-Specific Participants

Some early clinical, pharmacokinetic and bioequivalence programs need to be conducted in the intended patient population. CEBIS supports patient studies based on protocol requirements, eligibility criteria, clinical needs and study objectives, including patient-population PK/PD and clinical-endpoint BE studies.

Support can include:

Site and population planning
Participant identification
Screening
Study visits
Clinical and safety oversight
Sample collection
Retention support
Study follow-up

RECRUITMENT

Finding Participants

Who Match the Study

Recruitment needs vary by indication, eligibility criteria, location and study design. Recruitment approaches can include:

PARTICIPANT SUPPORT

Supporting Participants Throughout the Study

Participant engagement continues after enrollment. Retention support helps participants remain connected with the study throughout their participation.

Support may include:

Appointment reminders
Calls, texts and email communication
Study-related participant education
Compliance and adherence reminders
Practical support with study visits where appropriate
Continued communication throughout participation

INTEGRATED STUDY SUPPORT

Participant Activities Connected to the Wider Study

Participant visits are only one part of the clinical study.

CEBIS can coordinate participant-related activities with clinical operations, sample collection, bioanalysis, data management, pharmacokinetic analysis and safety oversight.

Clinical Operations

Study and participant activity coordination.

Bioanalytical Services

Analysis of samples generated through the study.

Data Management

Review and management of clinical study data.

Pharmacokinetics & Biostatistics

Analysis and interpretation of study results.

Safety & Medical Oversight

Clinical and safety review throughout participation.

Planning a Healthy Volunteer or Patient Study?

Tell us about the study design, participant population, eligibility requirements, recruitment needs and expected timeline. A member of the CEBIS team can discuss the appropriate study approach.