LARGE MOLECULE & BIOSIMILAR DEVELOPERS

Integrated Clinical Development Support

for Biologic and Biosimilar Programs

CEBIS can coordinate clinical development services for biologic and biosimilar programs, connecting study planning, clinical operations, regulatory support, data, statistics, safety, medical writing and bioanalytical activities around the requirements of the program.

Support can be structured as focused functional services or a more integrated development model.

BIOLOGIC DEVELOPMENT

Coordinating Clinical Functions for Complex Programs

Large-molecule and biosimilar programs can require close coordination across clinical study activities, regulatory requirements, safety, data review and supporting analytical work. CEBIS can coordinate these functions across Phase I–IV development.

PHASE I–IV

Support from Early Clinical

Studies Through Later-Phase Development

CEBIS supports Phase I through Phase IV development, including patient-population Phase I and other complex early-phase studies where appropriate to the program.

Early Clinical Development

Coordinate appropriate early clinical, pharmacokinetic, safety, data and analytical requirements based on the product and study design.

Phase II–III

Support multi-site clinical execution through project management, site oversight, monitoring, data, statistics, regulatory and safety functions.

Late Phase & Post-Marketing

Support appropriate observational or post-marketing evidence activities after the earlier clinical-development stages.

INTEGRATED SERVICES

Clinical, Analytical and Regulatory

Functions Around the Program

Clinical Trial Management

Project planning and coordination across participating functions.

Clinical Operations

Sites, monitoring, recruitment, supply and operational oversight.

Bioanalytical Services

Where relevant to the program, bioanalytical support can include method development, validation and clinical-sample analysis.

Data & Biostatistics

Data management, analysis and statistical support.

Regulatory Affairs & Medical Writing

Study documentation and regulatory activities throughout development.

Pharmacovigilance & Medical Monitoring

Safety and medical oversight aligned with study requirements.

PK & BIOANALYSIS

Connecting Clinical Samples

to Study Data

Clinical development may require coordination between participant activity, sample collection, bioanalysis, pharmacokinetics and statistical evaluation. CEBIS can coordinate these functions, with the analytical approach defined around the specific molecule and study.
Connected workflow:

REGULATORY & SAFETY

Development Functions That Stay Connected to the Study

Biologic and biosimilar studies still require structured regulatory, safety and medical oversight throughout study delivery.

CEBIS can coordinate:

Support is tailored to the specific product and development pathway rather than applying one model to every biologic or biosimilar program.

BIOSIMILAR DEVELOPMENT

A Development Pathway That

Requires Verified Expertise

CEBIS capabilities that can contribute to large-molecule and biosimilar development programs include:

Clinical study planning and execution
PK support where appropriate
Bioanalysis
Data management
Biostatistics
Regulatory affairs
Medical writing
Pharmacovigilance and medical oversight

VERIFIED EXPERIENCE

Biologic & Biosimilar Experience

BIOLOGIC & BIOSIMILAR CLINICAL DEVELOPMENT SUPPORT

Planning a Biologic or Biosimilar Clinical Program?

Tell us about the molecule, development stage, study objectives, analytical requirements, countries and services you need. A member of the CEBIS team can discuss the appropriate clinical-development support.