Convert Complex Scientific Data into Clear and Compliant Statements
Shen’s expert medical writing team provides agile support for effectively communicating clinical trial information to patients, research sites, and regulatory authorities. With over 25 years of experience collaborating with pharmaceutical, biotech, government, and medical device clients, Shen’s medical writers excel at translating complex scientific data into high-quality, compliant content across a comprehensive range of documents:
1. Protocols and Informed Consent Forms
2. Clinical Study Reports and Patient-Friendly Summaries
3. Patient Narratives
4. Investigational New Drug (IND) Applications
5. Briefing Documents and Regulatory Responses
6. Nonclinical Reports and Common Technical Document (CTD) Summary Modules
7. Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), and Clinical CTD Modules for Marketing Applications
Shen ensures that your clinical trial information is not only effectively communicated but also optimized for search engine visibility.
Extensive Medical Writing Solutions: Meeting Your Expertise Needs in Full Spectrum
At Shen, our comprehensive medical writing solutions are backed by a wealth of expertise spanning various therapeutic areas and document types, ensuring rapid alignment with your program and regulatory requirements.
We cover all aspects of medical writing across the development life cycle, including:
- Preclinical: Managing Investigational New Drug (IND) modules, annual reports, investigator’s brochures (IB), and briefing documents.
- Phase II-IV: Overseeing protocols and amendments, IB updates, informed consent materials, clinical study reports (CSR), CSR narratives, appendices compilation, CSR redaction and anonymization, lay summaries, briefing documents, and white papers.
- Marketing submissions: Crafting Marketing Authorization Applications (MAA), including New Drug Applications (NDA) and Biologics License Applications (BLA), biosimilar materials, submission package anonymization, 120-day updates, comprehensive narrative programs, and responses to regulatory agencies.
Our specialized medical writing teams are dedicated to ensuring quality and patient-centricity, enabling you to initiate your projects with confidence.
- Quality Review: Our experienced staff, located across the globe, meticulously uphold quality control and compliance with Shen’s or client-specific processes for all documents.
- Patient-Centric Writing: Our materials incorporate appropriate messaging, tone, and readability levels to effectively engage with patients.
Perfecting Talent, Expertise, and Engagement Strategies
“Shen’s FSP Medical Writing Team: Comprising True Experts, Including Pharm.D., M.D., Ph.D., and Master’s Level Writers, With Diverse Therapeutic Experience and Extensive Industry Tenure, Offering a Comprehensive Array of Regulatory Documentation Services.
Our dedicated Shen FSP Medical Writing Solutions Team consists of highly seasoned medical writers who excel in problem-solving and translating intricate scientific data into clear, precise statements. We are committed to producing documents that uphold scientific accuracy and strict compliance with regulatory standards, industry best practices, and client-specific guidelines.”
Collaborative Partnership at Every Level Ensures Timely and Accurate Deliverables
Our Structure: Promoting Responsiveness, Alignment with Your Organizational Culture and Values, and Deep Subject-Matter Expertise in Your Products. A Streamlined and Flat Governance Model for Enhanced Communication and Accountability.
Shen’s FSP Medical Writing teams harness our established structure to drive efficiency and consistency throughout the process.
- Each engagement features a dedicated medical writing program manager, serving as the primary point of contact to facilitate strong and transparent communication.
- Lead medical writers maintain direct communication with client writing teams and experts, ensuring efficient and targeted interactions.
- We prioritize maintaining a consistent project team, allowing allocated writing resources to become subject matter experts in your programs, seamlessly integrating with your teams.
Leveraging our Asset Point of Contact (APoC) model, one of our team members becomes a subject-matter expert in one or more of your products, ensuring messaging consistency across all program documents.
Bespoke Engagement Models Designed to Meet Your Distinctive Needs
Customized Engagement Solutions: Filling Service Gaps and Providing Scalable Teams of Medical Writers and Editors, All Tailored to Your Needs.
We recognize the value of a flexible mix of systems and processes—whether they’re yours or ours. This flexibility allows you to quickly adjust resource levels to keep pace with growth or changes in your portfolio. Moreover, we offer the option to embed our medical writing staff within your organization.
Our innovative pricing models accommodate various contract structures, including full-time equivalent (FTE), unit-based, time & materials, and hybrid models. These adaptable models can be tailored to evolve with your changing needs.
SHEN's END TO END DRUG DEVELOPMENT AND CLINICAL TRIAL SOLUTIONS
Deadline Mastery: Streamlined Processes and Tools
Shen’s Dynamic Approach to Clear and Efficient Data Presentation
At Shen, we’re all about delivering data that’s not just clear and concise, but also highly versatile. We’ve adopted a streamlined authoring method that ensures our text is easy to understand and can be repurposed effortlessly in various documents.
Our secret sauce? We leverage cutting-edge tools and capabilities that accelerate document development, facilitate real-time collaborative reviews, maintain data integrity, and provide automation options for fully programmed and hybrid narratives. Plus, we seamlessly address disclosure requirements alongside protocol and CSR development.
We’re not just talk—our actions speak volumes. We use versatile software to foster transparency and collaboration, making it a breeze to reach team consensus quickly. To safeguard data integrity, we rely on Programmed in Text Tables. And when it comes to polishing our work, proofreading software is our go-to, customizable to your unique style preferences.
But that’s not all. Our process improvement lead is always on the lookout for new efficiencies, making sure your projects run even smoother. And to top it off, we offer a dedicated medical writing program manager who fosters a partnership-driven approach, allowing for direct contact with essential team members and reducing the need for extensive client oversight. At Shen, we’re not just meeting deadlines; we’re exceeding 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 Presence and Strategic Team Placement
To offer round-the-clock support that aligns with your needs, we have a global team with a strong presence in North America, Europe, Africa, and Asia-Pacific. Key roles are strategically positioned in the same time zones as your functional and clinical teams, forging a seamless partnership that operates as one cohesive unit.
This proven strategy allows us to form high-performing medical writer teams, foster knowledge exchange, and cultivate positive and productive interactions throughout our collaboration.