PHASE II–III CLINICAL DEVELOPMENT

Full-Service Support for

Phase II–III Clinical Trials

CEBIS supports Phase II and Phase III clinical programs with integrated trial planning, project management, site oversight, clinical monitoring, enrollment support, data management, biostatistics, regulatory, safety and medical writing services.

Our teams can manage individual study functions or coordinate multiple services across a broader clinical development program.

PHASE II–III DELIVERY

From Proof of Concept

to Confirmatory Trials

CEBIS supports Phase II dose-ranging and proof-of-concept studies and Phase III confirmatory trials through integrated clinical operations, medical oversight and data delivery. We focus on recruiting the right patient population, maintaining consistent endpoint assessments and generating reliable efficacy and safety data.

Study Strategy & Planning

Align operational plans with dose selection, efficacy endpoints, safety assessments and sample size. Evaluate countries, sites and eligible patient populations to establish recruitment targets and study timelines.

Study Start-Up

Coordinate regulatory and ethics submissions, site contracts and budgets, and vendor selection. Prepare monitoring plans, electronic data capture systems and study-specific workflows, including randomization and blinding where applicable.

Site Activation & Training

Confirm site readiness and train investigators and study teams on eligibility criteria, treatment administration, endpoint assessments, safety reporting and protocol requirements. Standardize assessor training across sites where required.

Patient Recruitment & Study Conduct

Manage recruitment, screening and retention against site targets. Monitor protocol adherence, treatment compliance, investigational product accountability and completion of scheduled efficacy and safety assessments.

Medical Oversight, Data & Analysis

Review safety trends, protocol deviations and endpoint data throughout the study. Manage data queries and reconciliation, support independent safety committees where required, and complete database lock and statistical analysis.

Study Closeout & Regulatory Reporting

Complete site closeout, investigational product reconciliation and essential document archiving. Prepare clinical study reports and analysis outputs to support regulatory submissions and responses to authority queries.

CLINICAL OPERATIONS

Coordinated Site Management
and Monitoring

Multi-site Phase II–III studies depend on consistent execution across participating centers. CEBIS supports site management and clinical monitoring throughout the study lifecycle, with activities adapted to the study design and identified risks.

Site Management

Ongoing coordination with participating sites around study activities, documentation, outstanding actions and operational needs.

Site Initiation

Preparation and initiation activities designed to help sites understand the protocol, study systems and operational expectations.

Routine Monitoring

Ongoing review of study conduct, documentation and data during active trial execution.

Risk-Based Monitoring

Targeted oversight focused on critical study risks, data and areas that require additional attention.

For-Cause & Co-Monitoring Support

Additional site oversight when a specific issue, risk or sponsor requirement calls for focused monitoring.

Closeout

Final monitoring and site activities support study completion and documentation readiness.

PATIENT ENROLLMENT

Supporting Recruitment,
Retention and Study Participation

Enrollment can become a major operational challenge in Phase II–III programs. CEBIS can support recruitment and participant engagement activities in coordination with participating sites and the study’s eligibility requirements.

Current CEBIS recruitment approaches include:

Patient and investigator database screening where permitted
Chart and medical-record review where appropriate
Calls, texts and email outreach
Referral networks
Digital and social-media campaigns
Site and community outreach materials
Visit reminders
Ongoing participant communication
Retention and adherence support

STUDY DATA & OVERSIGHT

Clinical Execution Connected to
Data and Safety

Site execution is one part of a Phase II–III program. Clinical operations, data management, biostatistics and safety activities need to remain aligned throughout study conduct and through final reporting.

Data Management

Data coding, review, cleaning, validation, reconciliation and preparation for database lock.

Biostatistics & Statistical Programming

Statistical planning, analysis, programming and interpretation aligned with study objectives.

Pharmacovigilance & Medical Oversight

Safety surveillance, medical review, safety reporting and ongoing clinical oversight.

Regulatory Affairs

Support for regulatory and ethics activities during start-up and throughout study conduct.

Medical Writing

Support for study documents and final clinical or regulatory reporting.

PROJECT OVERSIGHT

Clear Visibility Across

the Program

Phase II–III studies can involve multiple sites, vendors and functional teams. Project management helps keep these moving toward shared study milestones while giving sponsors a clear view of progress and emerging risks.

Milestone Management

Track key study activities, dependencies and timelines.

Cross-Functional Coordination

Align clinical, regulatory, data, safety, supply and quality activities around the project plan.

Risk & Issue Management

Identify operational risks, escalate significant issues and follow actions through resolution.

Vendor Coordination

Coordinate relevant external study partners and service providers around agreed responsibilities and timelines.

Sponsor Communication

Provide clear communication around study progress, risks, decisions and upcoming priorities.

FLEXIBLE DELIVERY

Support Built Around

the Program

Sponsors do not always need the same outsourcing model. CEBIS can support a specific clinical-development function or coordinate multiple services across a Phase II–III study.

Functional Support

Engage CEBIS for a defined service such as project management, monitoring, data management, biostatistics or safety.

Integrated Study Support

Combine multiple clinical-development functions under a coordinated delivery model.

Multi-Site Programs

Support clinical studies requiring consistent execution and oversight across multiple participating sites.

Multi-Country Programs

Coordinate study activities across countries where CEBIS has established capabilities and appropriate delivery support.

STILL DEFINING YOUR PROGRAM?

Planning a Phase II or Phase III Clinical Trial?

Tell us about your protocol, study phase, countries, sites, patient population and required services. A member of the CEBIS team can discuss the appropriate delivery model for your program.