Clinical Research Services
Medical Writing
Led by top-tier medical talents, we have successfully facilitated the approval and launch of over 100 drugs, delivering high-quality, professional, efficient and compliant medical writing services for you.
Medical Writing
INTRODUCTION
The Medical Department’s team comprises high-end talents in clinical medicine, pharmacy, life sciences and other fields—over 25% doctoral, 85%+ master’s or higher—with rich project experience and expertise to successfully launch over 100 drugs and medical devices; covering oncology, cardiovascular diseases, metabolism & endocrinology, infection & immunology and other areas, it offers full-process services including medical strategy planning, Phase I-IV clinical trial protocol writing, medical monitoring and quality control, supported by team members’ solid academic backgrounds and drug regulatory authority experience for tailored solutions, while adhering to SOP and ICH-GCP standards via internal cross-departmental and dual external sponsor-investigator reviews to ensure document compliance and scientificity, providing professional support throughout project initiation, execution and conclusion to help clients achieve product development goals.
OUR SCALE
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150+Clinical Research Services
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70+Medical Device Registration Services
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20+Innovative Medical Device Registration Services
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60+Obtain Registration Certificate
OUR ADVANTAGES
Highly Educated Talent Pool
The core team consists of high-end professionals in clinical medicine, pharmacy, life sciences and other fields: over 25% hold doctoral degrees, and more than 85% have master’s degrees or above.
Extensive Project Experience
We have undertaken over 1,000 clinical trial projects, successfully launching more than 100 drug/medical device varieties.
End-to-End Service Capability
We cover the entire new drug R&D process, including medical strategy, protocol writing, medical monitoring, and quality control.
SERVICE CONTENT
Medical Strategy
- Product development pathway planning, and review trend analysis
- Population/dosage/treatment course optimization, and overseas data conversion
- Safety risk management and response plan design
Medical Writing
- Phase I-IV clinical trial protocols, and BE trial protocols
- Informed consent forms, investigator’s brochures, and case report forms (CRF)
- NDA/IND application materials, and clinical study reports (CSR)
Medical Monitoring
- Execution phase: Inclusion/exclusion review, AE/SAE medical review, and protocol deviation management
- Closure phase: Data cleaning support, and CSR medical review
SERVICE CASES
- Oncology
- Cardiovascular
- Metabolism & Endocrinology
- Infection & Immunology
- Gastroenterology
- Neurology
- Ophthalmology
- Dermatology, etc.
QUALITY CONTROL SYSTEM
Internal Quality Control
Cross-departmental review by PM, statistics and data management teams ensures professionalism and format compliance.
External Quality Control
Dual review by sponsors and investigators, strictly adhering to SOP and ICH-GCP.
Quality Assurance
Regular audits and SOP updates to ensure document compliance and scientific validity.