MEDICAL WRITING SERVICES DESIGNED TO SUPPORT YOU
Clinical/Non-Clinical
We offer a suite of specialized writing solutions to support your regulatory submissions, documentation, and communication needs. Whether you're navigating the complexities of clinical trial protocols, preparing regulatory submissions, or crafting scientific narratives, we have the expertise to ensure your documents are precise, compliant, and impactful in moving your program forward.
Intro to CERs Training Course
This course includes an overview and introduction to the clinical evaluation process. Complete with GLOBAL’s best practices and tips and tricks for success, this essentials course is perfect for getting novice writers on your team up and running. This training course includes:
• Live, online training sessions
discussing CER components and key strategies for success
• Access to recorded training sessions for reference
EU MDR Professional
Mentorship Program
Our professional mentoring program follows GLOBAL’s unique internship structure, customized for your team’s workflows, procedures, and device portfolio. Key aspects of the program include:
• Live, online training sessions with recordings and slide decks
• Practice assignments with answer keys
• Personalized feedback and guidance on the EU MDR documents in your team's pipeline
CER Bootcamp
The CER Bootcamp Course is an intensive training program designed to provide a thorough introduction to the clinical evaluation process. Tailored for novice writers, this course leverages
GLOBAL’s best practices, tips, and tricks to get your team up and running efficiently. Combining live, interactive sessions with comprehensive resources, the bootcamp ensures participants gain
the essential skills needed to produce high-quality Clinical Evaluation Reports CERs).
Train the Trainer Masterclass
The Train the Trainer Masterclass is aspecialized program designed to equip trainers with the skills and knowledge needed to effectively teach and mentor teams in the key deliverables required for EU MDR compliance (CER/CEPs, PMCF Plans/Report, PMCF Plans/Reports, PMSPlan/PSURS and PMS Reports).
Leveraging GLOBAL’s proven methodologies and best practices, this masterclass ensures that trainers are fully prepared to deliver high-quality, impactful training sessions and provide ongoing mentorship.
Custom Training Solutions
At GLOBAL, we understand that each organization has unique needs and challenges. That's why we offer custom training solutions designed to empower your team with the specific knowledge and skills required to write effective and compliant Clinical Evaluation Reports (CERs) and other EU MDR deliverables. Our bespoke training programs are crafted to align with your workflows, procedures, and device portfolio, ensuring immediate and practical application.
Let’s Navigate Your Next Project Together
Our medical writing team capabilities include:
• Clinical trial documents
• Regulatory interaction documents
• Submission documents
• Safety documents
• Project management
• Publishing
• Support for both pharmaceuticals and medical devices
The GLOBAL Team Approach:
• Agile support with creative problem solving skills to support client goals
• Writers with unique skills sets offering full circle knowledge of nonclinical
requirements and their impact to clinical development programs
• Team approach offering continuity and consistency to our Sponsors across
programs
• High rate of repeat business due to excellence in performance
• Flexible contracting arrangements to accommodate your project and
budgetary needs
Why Partner with GLOBAL for Clinical/Non Clinical Medical Writing Services?
Comprehensive Expertise
End-to-end support across clinical and nonclinical writing, regulatory submissions, safety documents, and publishing for both pharmaceuticals and medical devices.
Proven Team Approach
Agile, creative problem-solving writers with full-circle knowledge of nonclinical and clinical requirements, ensuring consistency and continuity across programs.
Trusted Performance & Flexibility
High repeat business from satisfied sponsors, with flexible contracting options tailored to project scope and budget.