中文

CRO - Digitized Clinical Trial Outsourcing Service

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Applying the integrated cloud platform,from study execution, quality management to risk control for clinical trials, we are responsible for data quality of the study. We are your best partner providing clinical trial solutions with low-risk, low-cost and high-value in China.

Full-Process of Clinical Development Services
from Strategic Planning to Post-Market Study

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Clinical Operations for New Drug Development from Phase I to Ⅳ Studies

  • Feasibility study, consultation preparation and organization
  • Clinical study management and execution within the study timeframe and budget
  • Site evaluation, selection and study start-up
  • Site monitoring, risk-based monitoring
  • Subject enrollment and retention
  • Site close-out
  • Risk management based on trial design, study phase, critical data and process of specific study
  • Compliance with ICH GCP, local regulatory requirement and relevant standards in project execution

Clinical Sciences, Regulatory Affairs and Medical Affairs

  • Clinical strategy development (medical science, market and therapeutic unmet needs and regulatory strategies)
  • Consultation with CDE, KOLs and professionals
  • Pre-IND Meeting coordination
  • Protocol development & adaptation
  • Medical Monitoring/Medical Writing (IB, ICF, CSR)
  • Drug safety (safety medical review for SAEs, SAE/SUSAR reporting)
  • Pharmacovigilance
  • Risk control & management





Quality Management, Training and the 3rd Party Audit

  • Independent GCP/GCLP system audit
  • Whole-process audit (TMF, IC process, protocol development, DM&ST, CSR, PV) and vendor qualification review
  • Quality system establishment for clinical research
  • Self-assessment, inspection readiness support and training to ensure the best inspection outcome
  • Risk assessment, risk & issue trending analysis, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) development, GCP significant issue investigation




Value Added Services

  • Site Information Database and Study Start Up (SSU)

    Take the best usage from the Big Data which we generated from sites via WeTrial platform, including site information, users’ behavior analysis and relevant analysis in various dimensions base on project’s needs, we make sites selection smarter, study start up quicker!


  • e-Subject Recruitment

    Take the accurate results from matches of potential subjects with specific protocol criteria, we accelerate the progress of subject enrollment, bring benefits, diagnosis and treatment value for patients in need.

New Drug Development Strategy And Clinical Execution System

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Efficiency Made by Creative Strategies plus Innovative Systems

Strategy

  • Comprehensive drug development strategy
  • Site selection and Quick Start Strategy
  • Subject recruitment strategy

System

  • Dedicated-project-team
  • Digitized clinical operation management system
  • Optimized clinical quality management system

Project as the core

•Based on the principle of project-oriented, CTS’s “dedicated-project-team” service is a unique clinical project management solution in China.

•To team up base on the project specific needs – each individual CRA will only be deliciated in one project at the same time.

•PM is fully delegated in the project – PM has the ability and authority to allocate and deploy company’s resources in an emergency, and to interact directly with stakeholders to ensure the efficiency and quality of projects.

Resource Integration & Collaboration

•A reliable resource collaboration platform is constructed by internal professionals, including Medical, QC, QA, Training and CTMS Application Support team, so as to provide best and in-time supports to the front-line teams.

•We aim to ensure the continuous empowerment to each project team that critical issues or risks are well under control.

Digitized Strategies and Actions

•Our goal is to establish digitized clinical management platform; allow stakeholders to make evidence-based strategies and decisions; provide immediate supports and guidance to front-line team members; recruit top talent. That differentiates CTS from other CROs!