Protocol Development
We craft clear, scientifically sound protocols that translate research objectives into executable study plans. Our protocols include comprehensive methodology, precise eligibility criteria, and detailed procedures while ensuring alignment with regulatory guidelines and ethical standards.
Clinical Study Reports (CSRs)
We develop ICH E3-compliant CSRs that comprehensively document study methods, results, and conclusions. Our writers integrate statistical analyses, safety data, and efficacy outcomes into cohesive narratives that support regulatory submissions and publication efforts.
Regulatory Submission Documents
We prepare integrated summaries of efficacy and safety (ISE/ISS), clinical overviews, and clinical summaries for regulatory dossiers. Our submission-ready documents present compelling benefit-risk assessments while addressing regulatory requirements across global markets.
Patient Narratives
Our team creates detailed narratives for serious adverse events, deaths, and other significant clinical events. We synthesize medical histories, concomitant medications, and event details into clear chronological accounts that support safety evaluations.
Investigator Brochures
We develop and update investigator brochures with current non-clinical and clinical data. Our documents provide investigators with comprehensive drug information to support informed patient management while maintaining regulatory compliance.
Publication Support
We prepare manuscripts for peer-reviewed journals, conference abstracts, and posters. Our scientific communication experts ensure accurate data representation and compliance with publication guidelines while developing compelling narratives that highlight your research significance.
Lay Summaries
We create clear, accessible summaries of clinical trials for non-scientific audiences. Our patient-friendly documents explain study results in plain language while maintaining scientific accuracy and meeting transparency requirements.
Quality Control and Editorial Services
Our comprehensive quality control process includes scientific and editorial reviews, reference verification, and formatting checks. We ensure document accuracy, consistency, and compliance with style guidelines while meeting submission deadlines.
