Professional, High-Quality Medical Affairs Services
Supporting the entire lifecycle of clinical research, ensuring scientific validity, safety, and feasibility.
SDM’s medical writing team has years of professional experience and expertise, providing comprehensive evaluations of the scientific validity, completeness, operability, and risk management of clinical trials. We offer comprehensive medical writing solutions throughout the clinical research process, supporting the successful preparations and submissions of IND, NDA and other regulatory documents.
Our Solutions
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1
Writing and reviewing of clinical trial protocols and summaries (including phase I-IV drug trials, medical devices, aesthetic medicine and in vitro diagnosis)
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2
Writing and reviewing of informed consent forms and investigator brochures
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Writing and reviewing of clinical study reports (including case narratives)
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4
Writing and reviewing of clinical development plans, clinical summaries, and 2.5 clinical overviews
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Literature research and compilation
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Clinical research meeting support (meeting material preparation and meeting summary)
Our Strengths
Professional and Standardized Writing Services
Our team consists of experts from clinical medicine, pharmacy, life sciences and related fields. We follow international ICH-GCP guidelines, Chinese GCP principles, and international regulations and guidance such as the Helsinki Declaration and the International Ethical Guidelines for Biomedical Research.
Extensive Project Experience
Our medical writing team has developed comprehensive templates and SOPs, offering medical writing services across a wide range of therapeutic areas, including oncology, endocrinology, autoimmunity, cardiovascular, dermatology, neurology, infectious diseases, and gynecology.
Strict Quality Management
Our medical writing services follow professional medical writing standard and strict proofreading and review process based on established SOPs. Throughout the writing process, we collaborate efficiently with sponsors, domain experts, biostatisticians, clinical pharmacologists, pharmacovigilance teams, and others to ensure the scientific accuracy, completeness, and operability of all documents.
Learn how our medical strategy services, tailored to your market and product characteristics, can help accelerate your clinical trial process and regulatory submissions.
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