TriApex, committed to the regulatory thinking throughout the clinical service, has led and participated in hundreds of various clinical trials, covering indications such as oncology, ophthalmology, central nervous system and endocrine diseases.
TriApex provides scientific, regulatory-compliant, high-quality and high-standard services to enable marketing authorization for our sponsors. We have cooperated with more than 100 large pharmaceutical industries and biotechs, maintained friendly cooperative relationships with many domestic clinical research facilities, and established a high quality brand in the industry.
Service AdvantagesTriApex is committed to the regulatory thinking that leads drug discovery throughout the whole procedures (project establishment, R&D, application, review and approval).
R&D establishment:
Demand-based; make most use of advantages; perform a multidisciplinary evaluation of regulatory strategies; interpretation and analysis of the policies, regulations and development routes
Medical strategy:
Clear positioning, scientific design; make a plan for fast marketing based on advanced regulatory and medical strategies.
Clinical operation:
Strategic layout, high-quality and efficient, an efficient operational strategy based on the clinical positioning and development thinking.
Review and approval:
Be versed in relevant laws and regulations and professional regulatory affairs; formulate customized procedures for application; coordinate the progress of various studies; actively respond to the review.
Service CapacitiesRegulatory affairs, medical affairs, project management, clinical operation, data management, pharmacovigilance, third party audit, etc.
TriApex provides efficient and high-quality medical design, medical monitoring and medical writing to ensure the scientificity, integrity and safety of clinical studies.
TriApex makes sure the clinical research is conducted in compliance with relevant SOPs, applicable regulations, scope of work, and the requirements of sponsors.
TriApex has well-established standard operating procedures, and in-depth knowledge of global standards and best practices. We are dedicated to providing professional and efficient clinical data management services from protocol review to database delivery.
TriApex helps sponsors to establish the quality management system and provide better quality assurance for clinical studies to jointly ensure the safe drug use.
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