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Menu
Services
Regulatory
Clinical Documentation
Briefing Book
Clinical Development Plan
Clinical Study Protocol (CSP)
Clinical Study Report (CSR)
Lay Summaries
Common Technical Document (CTD)
Informed Consent Form (ICF)
Investigator’s Brochure (IB)
Investigational Medicinal Product Dossier (IMPD)
Investigational New Drug (IND)
Paediatric Investigation Plan (PIP)
Pediatric Study Plan (PSP)
Responses to Authority Questions
Clinical Evaluation Report (CER)
Other Documents
Postmarketing
Postmarketing Studies
Pharmacovigilance
PV & Product Safety
120 Day Safety Update (4 Month Safety Update)
Development Safety Update Report (DSUR)
Periodic Adverse Drug Experience Report (PADER)
Periodic Safety Update Report (PSUR)
Periodic Benefit Risk Evaluation Report (PBRER)
Risk Evaluation and Mitigation Strategies (REMS)
Risk Management Plan (RMP)
Communications
Scientific Communications
Abstracts and Manuscripts
Posters and Slide Sets
Training
Training Overview
Training Portfolio
Foundation Skills Training Programme
Preparing Specific Clinical Documents
Strategic Communication Skills
Why Trilogy?
What is Medical Writing?
Why use Trilogy?
Outsourcing
Expertise
Therapeutic Areas
Development Areas
Trilogy Benefits
How We Work
Trilogy Style Guide & Tools
Document Review Process
Customer References
Trilogy Brand Brochure
TriloDocs
TriloDocs | The AI Tool
About Us
Our Story
Trilogy Management Board
FAQ
Resources
TriloTalk | Podcast
Publications
Medical Writing Special Editions
Special Edition: Medical Writing: The Backbone of Clinical Development
Special Edition: Medical Writing – A Bold New Path: The Future Awaits Us
Clinical Study Protocols: The Pillars of Clinical Development
Think Tanks
Glossary of Clinical Research Terms
News: Regulations & Standards
Careers
Come join us
Life at Trilogy
Contact
Classical Review Process
