REGULATORY, MEDICAL WRITING & SAFETY

Regulatory, Writing and Safety Support

Across Clinical Development

CEBIS supports clinical development programs with regulatory affairs, medical writing, pharmacovigilance and medical monitoring services that can be coordinated throughout the study lifecycle.

These functions help connect study planning, regulatory requirements, participant safety, clinical data and final study documentation.

CORE SERVICES

Support Across Regulatory,

Writing and Safety Functions

Regulatory Affairs

Regulatory strategy, clinical trial applications, ethics activities, submission support and lifecycle regulatory management.

Medical Writing

Support for protocols, investigator brochures, informed-consent forms, clinical study reports and other clinical or regulatory documents.

Pharmacovigilance

Safety case activities, literature review, reconciliation, lifecycle safety support and relevant reporting activities.

Medical Monitoring & Safety Reporting

Medical oversight and safety support connected to active clinical study conduct.

CROSS-LIFECYCLE SUPPORT

From Study Planning

Through Post-Marketing Activities

Regulatory, medical writing and safety activities can be coordinated across the development lifecycle alongside clinical operations, data management and biostatistics.

Planning & Development

Regulatory strategy, study documentation and preparation of required clinical materials.

Study Start-Up

Clinical trial applications, ethics / IRB activities and required study-document preparation.

Active Study Conduct

Ongoing regulatory support, medical monitoring, pharmacovigilance and study-document updates.

Study Completion & Beyond

Clinical study reports, regulatory documentation and continued safety or lifecycle support where required.

REGULATORY SUPPORT

Regulatory Activities Built Around the Product Lifecycle

Regulatory support can span development and post-authorization activities, including regulatory strategy, launch planning, line extensions, variations and lifecycle maintenance.

Regulatory support can include:

Regulatory planning
Clinical trial applications
Ethics and IRB coordination
Regulatory submissions
Study amendments
CTD-related documentation
Lifecycle regulatory activities
Post-authorization support where applicable

MEDICAL WRITING

Clear Clinical and

Regulatory Documentation

Medical writing support can include protocols, Investigator Brochures, Case Report Forms and Informed Consent Forms, as well as articles, abstracts, posters and publication-related materials.

Clinical & Regulatory Documents

Scientific Communications

DRUG SAFETY

Safety Support Across the Product Lifecycle

Pharmacovigilance support can include safety case handling, literature review, reconciliation, PV training, PSMF support, risk-management activities and vendor coordination.

Core areas can include:

Safety case activities
Literature surveillance
Safety-data reconciliation
Risk-management support
Safety documentation
Regulatory safety reporting
Vendor coordination
Ongoing lifecycle support

MEDICAL OVERSIGHT

Clinical and Safety Oversight

During Study Conduct

Medical monitoring connects clinical study activity with ongoing evaluation of participant safety and study-related medical issues.

Medical review
Clinical issue escalation
Safety information review
Coordination with pharmacovigilance
Support for safety reporting
Communication with clinical teams

INTEGRATED DEVELOPMENT

Regulatory and Safety Activities Connected to the Study Team

Regulatory, writing and safety functions need to remain aligned with the teams executing and analyzing the clinical study.

CEBIS can connect these services with:

Need Regulatory, Writing or Safety Support?

Tell us about the product, development stage, study, regulatory markets and services you require. A member of the CEBIS team can discuss the appropriate combination of support.