Protocol design, study document writing, and clinical research medical support
Based on product characteristics and clinical needs, design Phase I–IV clinical trial/IIT protocols, investigator brochures, informed consent forms, and other core study documents; provide full-process clinical research medical support, including protocol interpretation, medical monitoring, safety evaluation, and medical issue consultation.
Human genetic resources approval applications
Assist in the preparation of application materials for the collection, preservation, international cooperation, and export approval of human genetic resources under the Ministry of Science and Technology, including ethics committee pre-review and full-process follow-up.
Clinical study report writing
Preparation of clinical study reports (CSR).
Safety report writing
Annual safety reports (ASR), development safety update reports (DSUR), and post-marketing periodic safety update reports (PSUR); providing medical document integration and writing support for regulatory submissions.
Medical writing
Provide writing and submission support for academic content including papers, conference abstracts/posters, case reports, reviews, and white papers.
Top-level design
Integrating product positioning, competitive landscape, and unmet clinical needs, construct a full-lifecycle medical strategy framework from preclinical to post-marketing stages, and translate it into the formulation of specific optimal R&D pathways.
Regulatory strategy consulting
Provide communication strategy development with regulatory agencies, preparation of Pre-IND/Pre-NDA meeting materials, and submission pathway planning; interpret the latest regulatory policies and regulations, and assess their potential impact on product development.
Data mining and comprehensive evaluation
Utilize real-world data, bibliometrics, and other methods to mine evidence of product differentiation value, and conduct competitive product analysis, clinical positioning assessment, risk-benefit analysis, and market access strategy evaluation.
In collaboration with national-level academic societies and associations, we coordinate expert resources to organize or participate in the topic selection, evidence evaluation, formulation of recommendations, and dissemination of clinical practice guidelines/consensuses.
Clinical data management
Establish electronic data capture (EDC) systems, develop data management plans (DMPs), and execute data management tasks including data entry, validation, query management, and database lock.
Biostatistical analysis
Provide statistical consultation for trial design, sample size estimation, development of statistical analysis plans (SAPs), interim analyses, and generation of final statistical analysis reports.
Human experience research
Systematically collect, organize, and analyze human experience data from the pre-marketing or clinical use stage, including prescription origins, clinical use records, medical cases and discussions, and experience inheritance from renowned senior TCM practitioners; in accordance with relevant regulations and guidelines, standardize the collection, governance, and evidence evaluation of human experience data, providing human experience evidence support for TCM new drug registration applications and facilitating the construction of the "three-combination" review evidence system.
Real-world study
Design and execute post-marketing real-world studies for drugs, including intensive safety monitoring programs, cohort studies, and pragmatic clinical trials (PCTs), collecting long-term efficacy, safety, and health economic outcome data in routine clinical practice settings, providing real-world evidence support for product indication expansion, labeling updates, reimbursement access, and regulatory decision-making.
Data quality assessment
Establish a data quality management system and conduct systematic reviews of the completeness, accuracy, and consistency of clinical research data.
Our services cover the entire drug R&D lifecycle, from early human experience exploration, registration clinical trials, and pre-marketing preparation to all post-marketing stages. We are able to dynamically adjust medical strategies according to the product's stage of development, providing a "one-stop" medical affairs solution.
Our team brings together members from multiple disciplines including clinical medicine, pharmacy, biostatistics, and regulatory affairs, with deep professional expertise and extensive industry experience. We not only provide technical medical support, but also operate from a strategic business perspective, integrating medical evidence with product positioning, market access, and competitive landscape, facilitating the effective translation of medical value into commercial value.
We have established long-term strategic partnerships with experts across multiple disciplines, national-level academic societies and associations, and clinical research centers, enabling us to efficiently organize expert symposiums and conduct multi-center collaborative studies.
We strictly adhere to ICH-GCP, GMP, GSP, and domestic and international regulatory requirements (NMPA/FDA/EMA), and have established a robust SOP system and quality management system to ensure the scientific rigor, regulatory compliance, and traceability of all medical activities.
We actively embrace the digital transformation of medical affairs, utilizing innovative tools such as AI-assisted literature analysis, big data mining, and digital medical education platforms to enhance the efficiency of evidence generation and the precision of medical information dissemination.
WWe flexibly assemble project teams according to client needs, offering an elastic service model ranging from single-consulting to full-project outsourcing; we have established a rapid response mechanism to ensure timely medical decision support at critical milestones such as regulatory communications and pre-database lock.
With a professional and efficient service system and a comprehensive operational network, Guangzhou Evidence Based Medicine is committed to providing tailored one-stop traditional Chinese medicine research and development full industry chain service solutions for every customer, promoting traditional Chinese medicine to the world and safeguarding the health of more people.
