Professional, High-Quality Medical Affairs Services
Supporting the entire lifecycle of clinical research, ensuring scientific validity, safety, and feasibility.
SDM’s Medical Strategy team collaborates closely with regulatory, pharmacology, and statistics experts and has supported multiple submissions to the US FDA, Australian TGA and other agencies. We have successfully supported the design of MRCT Phase III study protocols leading to product approvals.
Our Strengths
Extensive Experience in Developing Clinical Trial Strategies
Expertise across various therapeutic areas, backed by SDM’s one-stop medical service platform, which enables efficient internal communication and rapid organization of project and medical strategy teams to provide optimal solutions.
Significant development experience with new molecule entities, new dosage form/formulation and new indications and me-betters. We also have expertise in designing clinical trial for overseas studies, including IITs, Phase I-III trials, post-marketing studies and real-world studies.
Significant development experience with new molecule entities, new dosage form/formulation and new indications and me-betters. We also have expertise in designing clinical trial for overseas studies, including IITs, Phase I-III trials, post-marketing studies and real-world studies.
Professional Medical Team
Our medical team is made up of professionals from clinicians, pharmacologists, epidemiologists, statisticians, and professionals from other fields. Team members come from renowned domestic hospitals, research institutions, the FDA, and multinational pharmaceutical companies.
We approach study design from multiple perspectives including enterprise strategy, product line planning, and clinical product positioning, to develop the optimal plan.
We approach study design from multiple perspectives including enterprise strategy, product line planning, and clinical product positioning, to develop the optimal plan.
Extensive Expert Resources
We have a specialized clinical strategy consulting team and extensive partnerships with opinion leaders and academic institutions in various therapeutic areas, both domestically and internationally. We can organize renowned PIs, experts with FDA and CDE review experience, and other top-tier specialists to guide clinical research and operations.
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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