Tailored Protocol Development
Get protocols that work for every trial, minimizing delays, maximizing compliance, and ensuring reliable outcomes without compromising scientific requirements.
- People‑first protocols with input from patients
- Seamless integration of research and clinical practice ideals
- Advanced expertise in research design, methodology, and statistics
- Challenges anticipated, agile solutions implemented
- Integration of principal investigator feedback
Clinical Study Reports for Phases I‑IV
Develop regulatory‑ready clinical study reports (CSRs) that meet ICH E3 guidelines, support publication, and deliver actionable insights for stakeholders through holistic medical writing services.
- Close collaboration between scientific leaders and medical writers
- Intimate familiarity with distinct regional regulatory requirements
- Full or abbreviated CSRs to suit your needs
- Clear, concise writing with detailed tables to enhance understanding
Expert Clinical and Statistical Reports
Drive informed decisions and regulatory success with relevant, robust analyses and reports that accelerate approvals and build credibility.
- Insights from leading statisticians and clinical researchers
- Visual data representation to provide clarity to lay observers
- Meta‑analyses by Ph.D.‑level experts for deeper understanding
- Reports designed to withstand stringent regulatory review
- Strategic recommendations for ongoing research development
Medical Writing Services for Every Trial
We want to see your life‑changing innovations out in the world, so quality assurance is vital to our process.
Our collaborative team delivers high‑quality protocols, investigator’s brochures (IBs), CSRs, statistical reports, and journal manuscripts, reacting quickly to global regulatory changes.
From the most complex early Phase I studies to post‑approval observational research programs, we offer optimized end‑to‑end medical writing services in multiple languages.
With world‑leading expertise and a commitment to excellence, our medical writing consultants craft the documentation you need and deliver it with care—together with you at every step.
Case Study
Supporting Pioneering Research
In a novel oncology food for special medical purposes (FSMPs) study, we provided a full service, including medical writing.
With protocol development requiring cross‑departmental coordination and complex regulatory issues involving submissions to multiple boards within an evolving environment, experience and adaptability were key:
- First‑of‑its‑kind trial in China
- 300+ patients enrolled
- Database lock and CSR finalization on time, despite COVID‑19’s impact
Through extensive regulatory knowledge, attention to detail, and strong communication, our medical writing services helped drive this trial forward.
See our impact in actionFrequently asked questions
What types of medical writing services do you offer?
We provide protocol development, investigator’s brochure (IB) development, clinical study reports (CSRs), data analysis and visualization, statistical reporting, and journal manuscript writing. Our medical writing consultants tailor each document to your trial’s unique requirements and regional specifications.
Do you provide support for regulatory submissions?
Yes, we can prepare and submit clinical trial applications to regulatory authorities, assist with any ongoing regulatory requirements, and support you with preparing and submitting Institutional Review Board or Ethics Committee documentation. See Regulatory Consulting for more information.
How do you ensure accuracy and compliance?
Bringing your therapies to the world is our priority, so quality assurance is at the heart of everything we do—including our medical writing services. Our established global network allows our experienced medical writers, regulatory experts, and scientific leaders to identify, analyze, and react to regulatory change worldwide as it happens.
Do you provide documents in multiple languages?
Yes, we are truly global medical writing consultants. With a dedicated team spanning 40+ locations, we provide medical writing services in multiple languages. Our local experts ensure that all documents are accurate, culturally appropriate, and compliant with regional regulatory requirements.
Related Services
Regulatory Consulting
Navigate the regulatory landscape with our global team, delivering tailored strategies and efficient clinical trial management from start‑up to safety reporting.
Study Design & Start‑Up
Partner with us to create custom, cost‑effective trial strategies that meet regulatory and sponsor requirements, regardless of project complexity.
Project Management
Drive clinical research success with our experienced project management team, seamlessly coordinating functional areas and vendors across the trial lifecycle.
Data Management & Biostatistics
Get accurate, secure, and integrated data management solutions and expert biostatistics services to streamline your study and maximize impact from start to finish.