PHASE I & EARLY CLINICAL DEVELOPMENT

Early Clinical Development Built

Around the Study Question

CEBIS supports early clinical development programs including first-in-human studies, pharmacokinetic studies, healthy-volunteer and patient studies, dose-escalation programs and other specialized Phase I requirements.

Clinical, bioanalytical, data, statistical, regulatory and safety activities can be coordinated around the needs of the program.

STUDY TYPES

Support for a Range

of Early Clinical Study Designs

Early development studies are designed around specific questions related to safety, tolerability, pharmacokinetics, dose and product behavior. CEBIS can support different early-phase study models based on the protocol and development plan.

First-in-Human Studies

Clinical support for studies evaluating a product in humans for the first time, with activities coordinated around safety, tolerability and early pharmacokinetic objectives.

Single Ascending Dose Studies

Support for SAD studies designed to evaluate increasing dose levels and generate early safety and pharmacokinetic information.

Multiple Ascending Dose Studies

Support for MAD studies evaluating repeated dosing, tolerability and pharmacokinetic behavior over multiple administrations.

Pharmacokinetic & PK/PD Studies

Clinical and analytical coordination for studies evaluating drug exposure, pharmacokinetics and pharmacodynamic endpoints.

Healthy Volunteer Studies

Early clinical and pharmacokinetic studies conducted in healthy participants where appropriate for the product and study objectives.

Patient Population Studies

Phase I or PK/PD studies can be conducted in defined patient populations when the protocol requires disease-specific participants.

PK & SPECIALIZED STUDIES

Study Designs Based on
Product and Development Needs

CEBIS supports a range of pharmacokinetic and specialized early-phase study designs to address different development questions.

Possible study designs include:

Single-dose studies
Multiple-dose studies
Fasting studies
Fed studies
Drug-food interaction studies
Healthy-volunteer PK/PD studies
Patient-population PK/PD studies
Studies in postmenopausal healthy participants
Clinical-endpoint studies where appropriate

INTEGRATED DELIVERY

Clinical, Analytical and
Data Functions Working Together

Early clinical studies often require several functions to move in parallel. Clinical execution, bioanalysis, pharmacokinetic evaluation, data management, statistics, safety and regulatory activities all need to remain aligned with the protocol and development timeline

CEBIS can coordinate these services as part of one early-development program.

Study Planning & Protocol Support

Study design input and planning based on the development question and required study endpoints.

Clinical Operations

Operational coordination, participant activities, site management and study execution.

Regulatory Support

Support for clinical trial applications, ethics activities and other regulatory requirements based on the study and region.

Bioanalytical Services

Method development, validation and sample analysis supporting pharmacokinetic and related study objectives.

Data Management

Data collection, review, cleaning, reconciliation and database preparation.

Biostatistics & PK Analysis

Statistical and pharmacokinetic analysis supporting evaluation of study results.

Safety & Medical Oversight

Clinical and safety review throughout study conduct.

Medical Writing

Support for protocols, study reports and other clinical or regulatory documents.

STUDY POPULATIONS

Study Support Based on the
Required Population

Early clinical programs may require healthy participants, defined patient populations or other protocol-specific participant groups. CEBIS can coordinate study operations around the population required by the protocol, including participant identification, eligibility, study visits, sample collection and ongoing study communication.

CEBIS supports studies in healthy volunteers, defined patient populations and postmenopausal healthy participants, depending on the protocol and study design.

Healthy Volunteers

Support for early clinical, PK and related studies in healthy participants where appropriate.

Patient Populations

Support for Phase I and PK/PD studies in patients where disease-specific participation is required.

BIOANALYTICAL SUPPORT

From Clinical Samples to
Pharmacokinetic Data

Early clinical studies frequently depend on timely coordination between clinical execution and bioanalytical sample analysis.

Bioanalytical support can include method development, method validation, sample analysis, pharmacokinetic support and services connected to BA/BE studies.

By aligning clinical, bioanalytical, data and statistical activities, study information can move efficiently from participant visits and sample collection through analysis and final interpretation.

PROGRAM CONTINUITY

Early Studies That
Support the Next Step

The purpose of early clinical development is not simply to complete a Phase I study. The data generated should help the sponsor understand the product and determine the appropriate next development step.

CEBIS can coordinate clinical, pharmacokinetic, analytical, statistical and reporting activities so study outputs are organized for continued development.

Planning a Phase I or Early-Development Study?

Tell us about the product, study design, participant population, pharmacokinetic requirements and expected timeline. A member of the CEBIS team can discuss the appropriate early-development support for your program.