PHARMACEUTICAL COMPANIES

Integrated Clinical Development Support

for Pharmaceutical Sponsors

CEBIS supports pharmaceutical development programs with clinical trial management, regulatory affairs, clinical operations, data management, biostatistics, safety, medical writing, bioanalytical services and other capabilities spanning Phase I through Phase IV.

Sponsors can engage CEBIS for a focused service or coordinate multiple functions around a broader development program.

PHASE I–IV

From Early Clinical Development

Through Post-Marketing Research

Pharmaceutical programs change as products progress through development. Early-stage studies, Phase II–III execution and post-marketing research each create different operational, regulatory, data and safety requirements.

CEBIS can connect those needs across the development lifecycle.

Phase I & Early Development

Clinical and pharmacokinetic studies, including appropriate healthy-volunteer or patient studies, BA/BE and bioanalytical support where relevant.

Phase II–III

Study planning, project management, site management, monitoring, recruitment, data management, biostatistics, safety and regulatory coordination.

Phase IV & Post-Marketing

Late-phase, observational and other post-marketing evidence-generation activities.

FLEXIBLE ENGAGEMENT

Engage CEBIS Around the

Needs of the Program

Pharmaceutical sponsors can engage CEBIS for individual functions or coordinated support across medical writing, regulatory activities, clinical trials, monitoring, data management, biostatistics and scientific publishing.

Focused Functional Support

Engage CEBIS for a specific requirement such as monitoring, data management, regulatory affairs, pharmacovigilance or bioanalysis.

Multi-Functional Support

Combine several related functions around one study.

Broader Clinical Trial Delivery

Coordinate project management and multiple clinical-development functions as part of a wider trial-management model.

INTEGRATED SERVICES

Clinical Development

Functions Connected Around the Study

Clinical Trial & Project Management

Planning, coordination, milestones and cross-functional study delivery.

Clinical Operations

Site management, monitoring, patient recruitment and supply coordination.

Regulatory Affairs & Medical Writing

Study documentation, regulatory activities and lifecycle support.

Data & Biostatistics

Data collection, review, database preparation, analysis and interpretation.

Pharmacovigilance & Medical Monitoring

Safety operations and medical oversight aligned with study requirements.

BA/BE, PK & Bioanalytical Services

Clinical, pharmacokinetic and analytical support where relevant to the development pathway.

EARLY DEVELOPMENT

Clinical and Analytical Support for Early Decisions

Early-development support can include PK studies on new molecules or modified formulations, patient-population Phase I studies, first-in-human and SAD/MAD studies, together with BA/BE services spanning protocol design, clinical execution, analytical quantification, pharmacokinetics, biostatistics and reporting.

Integrated support can include:

Phase I & Early Clinical Development
New Chemical Entity Studies
505(b)(2) Clinical Development
BA/BE & Pharmacokinetic Studies
Healthy Volunteer & Patient Studies
Bioanalytical Services

CLINICAL DELIVERY

One Study Requires More

Than One Department

Pharmaceutical programs may require sites, monitoring, regulatory support, data management, safety, biostatistics, supply and reporting to work together as one coordinated delivery model.
Connected areas:

PROGRAM EXPERIENCE

Therapeutic Experience

CEBIS’s therapeutic experience includes oncology, immunology, infectious diseases, rare disease, neurology and other areas.

PHARMACEUTICAL DEVELOPMENT SUPPORT

Planning a Pharmaceutical Development Program?

Tell us about the product, development phase, therapeutic area, countries, study requirements and services you need. A member of the CEBIS team can discuss the appropriate development approach.