Simplify Complex Scientific Data into Clear, Compliant Insights
Shen’s expert medical writing team delivers agile, precise support for communicating clinical trial information to patients, research sites, and regulatory authorities. With over 25 years of experience partnering with pharmaceutical, biotech, government, and medical device industries, Shen excels at transforming complex scientific data into compliant, high-quality content across a wide range of documents, including:
- Protocols and Informed Consent Forms
- Clinical Study Reports and Patient-Friendly Summaries
- Patient Narratives
- Investigational New Drug (IND) Applications
- Briefing Documents and Regulatory Responses
- Nonclinical Reports and Common Technical Document (CTD) Summary Modules
- Integrated Summaries of Safety (ISS) and Efficacy (ISE)
- Clinical CTD Modules for Marketing Applications.
Additionally, Shen ensures your clinical trial information is effectively communicated and optimized for maximum search engine visibility.
Comprehensive Medical Writing Solutions: Catering to Your Expertise Across the Spectrum
We provide comprehensive medical writing services throughout the entire development life cycle, including:
- Preclinical: Managing IND modules, annual reports, investigator brochures (IB), and briefing documents.
- Phase II-IV: Overseeing protocols, amendments, IB updates, informed consent materials, clinical study reports (CSR), CSR narratives, appendices, redaction and anonymization, lay summaries, briefing documents, and white papers.
- Marketing Submissions: Preparing MAA, NDA, BLA, biosimilars, submission anonymization, 120-day updates, comprehensive narrative programs, and regulatory responses.
Our expert medical writing teams ensure quality, patient-centric materials, empowering you to begin your projects with confidence.
- Quality Review: Our global team ensures strict quality control and compliance with Shen’s or client-specific standards.
- Patient-Centric Writing: We tailor materials to engage patients effectively through clear messaging, appropriate tone, and readability.
Perfecting Talent, Expertise, and Engagement Strategies
“Shen’s FSP Medical Writing Team: A Group of Expert Writers, Including Pharm.D., M.D., Ph.D., and Master’s-Level Professionals, With Extensive Therapeutic Expertise and Industry Experience, Providing a Full Range of Regulatory Documentation Services.
Our Shen FSP Medical Writing Solutions Team is composed of highly skilled writers who specialize in solving complex problems and transforming intricate scientific data into clear, accurate content. We are dedicated to producing documents that maintain scientific integrity while ensuring strict compliance with regulatory standards, industry best practices, and client-specific requirements.”
Collaborative Partnership at Every Level Ensures Timely and Accurate Deliverables
Our Structure: Designed for responsiveness, alignment with your organizational culture and values, and deep subject-matter expertise in your products. Our streamlined, flat governance model fosters enhanced communication and accountability.
Shen’s FSP Medical Writing teams leverage this structure to ensure efficiency and consistency throughout the process.
Each engagement is led by a dedicated program manager, serving as your primary point of contact for clear, transparent communication. Lead medical writers maintain direct communication with your team and experts, ensuring focused and effective collaboration. We prioritize consistency by keeping the same project team, allowing our writers to become subject-matter experts in your programs and seamlessly integrate with your teams.
Through our Asset Point of Contact (APoC) model, one of our team members becomes a product expert, ensuring messaging consistency across all program documents.
Bespoke Engagement Models Designed to Meet Your Distinctive Needs
Customized Engagement Solutions: Addressing Service Gaps and Delivering Scalable Teams of Medical Writers and Editors, Tailored to Your Specific Needs.
We understand the importance of a flexible approach, whether using your existing systems or ours. This adaptability allows you to quickly adjust resources to match the growth or changes in your portfolio. Additionally, we can seamlessly integrate our medical writing staff within your organization.
Our innovative pricing models support various contract structures, including full-time equivalent (FTE), unit-based, time & materials, and hybrid models, all designed to evolve with your changing requirements.
Deadline Mastery: Streamlined Processes and Tools
Shen’s Dynamic Approach to Clear, Efficient Data Presentation
At Shen, we focus on delivering data that is clear, concise, and highly adaptable. Our streamlined authoring process ensures content is easy to understand and can be seamlessly repurposed across various documents.
What sets us apart? We harness advanced tools that accelerate document development, support real-time collaborative reviews, ensure data integrity, and offer automation for both fully programmed and hybrid narratives. We also integrate disclosure requirements seamlessly alongside protocol and CSR development.
Our approach is results-driven. We use versatile software to promote transparency and collaboration, enabling quick team consensus. To protect data integrity, we rely on Programmed in Text Tables, and our proofreading software is customized to your specific style preferences.
Additionally, our process improvement lead constantly seeks efficiencies to streamline your projects. With a dedicated medical writing program manager at the helm, we prioritize direct, partnership-driven communication, reducing the need for extensive client oversight. At Shen, we don’t just meet deadlines—we exceed expectations.
Bespoke Assistance for Client-Specific Medical Writing Needs Across Countries, Regions, and the Globe
Ensuring 24/7 Coverage Across All Time Zones: Our Global Reach and Strategic Team Placement.
To provide continuous support tailored to your needs, we have a global team with a strong presence across North America, Europe, Africa, and Asia-Pacific. Key roles are strategically located in the same time zones as your functional and clinical teams, creating a seamless partnership that operates as a unified, high-performing unit.
This approach fosters efficient knowledge sharing, enhances collaboration, and drives productive, positive interactions throughout our engagement.