Trilogy Writing & Consulting
Falkensteiner Str 77
DE-60322 Frankfurt
Germany
Email: writers@trilogywriting.com
Website: https://www.trilogywriting.com/
Phone: +49(0) 69 138 2528-22
Skills and Services:
At Trilogy, medical writing is our passion. As specialists in regulatory documentation, we provide a service that is more than just writing. We have been helping pharmaceutical companies of all sizes, worldwide, to streamline their documentation processes for 20 years. Our writers are integral parts of our clients’ teams: proactively planning, coordinating and writing their regulatory documents to meet timelines, with a readability that reduces the time for review and approval.
Our writers are trained to think about the data available and work with the client teams to pull out the messages and present them as clearly as possible, so that a reviewer can quickly find the information they are looking for and easily understand the story to be told. Our approach to writing regulatory documentation ideally results in a minimum of clarifying questions from reviewers, speeding the process of review and ultimately leading to faster approval.
Expertise:
Trilogy specializes in writing all types of regulatory documents required in the course of a clinical development programme.
Pre-submission documents:
- Clinical Development Plans (CDPs)
- Clinical Study Protocols (CSPs) and Informed Consent Forms (ICFs)
- Investigator’s Brochures (IBs)
- Clinical Study Reports (CSRs)
- Lay Summaries
- Paediatric Investigation Plans (PIPs), Pediatric Study Plans (PSPs)
- Briefing Books
- Investigational Medicinal Product Dossiers (IMPDs), Investigational New Drug documents (INDs)
- Development Safety Update Reports (DSURs)
Submission documents:
- Common Technical Document (CTD) Module 2 (including ISS and ISE)
- Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategy (REMS)
- Assessment aids
- Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) for medical devices
Post-submission documents:
- Responses to authority questions
- Slide presentations and supporting documents for Advisory Committee Hearings (US) and Oral Explanations (Europe)
- Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs)
- Health Technology Assessment (HTA) reports
- Post-marketing and observational study documents (e.g., CSPs, CSRs)
Other Information:
Trilogy currently has more than 50 writers in 7 countries worldwide – Germany, the UK, Ireland, Portugal, Italy, the US, and Canada. We have 3 physical offices:
- Parent company and Head office: Falkensteiner Straße 77, 60322 Frankfurt am Main, Germany
- UK office: Merlin Place, Milton Road, Cambridge, CB4 0DP, UK
- US office: 200 Meredith Drive, Suite 201, Durham, NC 27713, US
Please, visit our website for additional information including short videos, which give an idea of the style and philosophy of Trilogy.