Medical Writing
Transforming Scientific Data into Clear, Compliant, and Impactful Documents
At Kernel,
Our Medical Writing service provides the vital link between raw research data and the broader healthcare community; whether that community consists of regulatory authorities, journal reviewers, policy-makers, or frontline clinicians. We bring together a multidisciplinary team of physicians, scientists, and technical writers whose expertise ensures accuracy, clarity, and alignment with international standards. Below is a detailed overview of how our medical writing can support your research at every phase and across multiple contexts.
Scope of Medical Writing Services
Protocol Development: We create comprehensive study plans detailing objectives, methodology, statistical considerations, and ethical safeguards in compliance with ICH E6 Good Clinical Practice (GCP).
Investigator’s Brochures: These summarize preclinical and clinical information on investigational products, enabling investigators and ethics committees to assess study feasibility and participant safety.
Readable, Ethically Sound Documents: Our writers balance scientific accuracy with lay-friendly language to comply with IRB requirements and ensure participants fully understand study risks and benefits.
Cultural & Linguistic Adaptations: For multinational or diverse populations, we tailor materials to cultural norms and reading levels.
Clinical Study Reports (CSRs): Structured in line with ICH E3 Guidelines, our CSRs thoroughly present efficacy and safety data, statistical analyses, and protocol deviations.
Annual Reports & Safety Updates: We compile and format Periodic Safety Update Reports (PSURs) and other regulatory documents to maintain compliance with agencies such as the FDA, EMA, SFDA, and MENA region health authorities.
Trial Master File (TMF) Documentation: We standardize essential regulatory binders, ensuring all sponsor, site, and product details remain inspection-ready.
- Observational Study Protocols & Reports
- Health Economics & Outcomes Research (HEOR)
- Manuscripts & Peer-Reviewed Publications
- Journal Articles
- Systematic Reviews & Meta-Analyses
- Congress Presentations & Abstracts
Policy Briefs & White Papers: Distilling complex epidemiological data into succinct, actionable recommendations for healthcare administrators and policymakers.
Grant Proposals & Funding Applications: We guide the narrative around public health imperatives, population-based interventions, and capacity-building projects that resonate with international funding agencies.
Strategy
Strategic Journal Targeting & Submission Management:
We identify the most appropriate journals (impact, scope, open-access mandates) and handle the entire submission package
Post-Publication Amplification: We transform your published research into accessible formats plain-language summaries, visual and media assets, and policy-ready materials to fulfill dissemination requirements.
Our Writing Process: Seamless Collaboration
Elevate Your Research Communications
From concept to publication, Kernel’s Medical Writing service ensures your research is disseminated with precision, integrity, and maximum impact. Ready to streamline your clinical documentation, regulatory submissions, or scientific publications? Contact us to learn how we can amplify your research voice and translate your findings into real-world change.