Clinical Trial Service

Clinical Trial Service

广州科犁医学研究有限公司(以下简称“科犁”),总部位于广州,是一家创新CRO企业,服务产品包括生物药、化药、细胞/基因治疗、器械等,业务涵盖临床研究I~IV期,专注于提供注册申报、方案设计、数据管理、统计分析、医学监查及医学撰写、DMC及CEC、临床研究定制化培训及咨询等服务。 科犁拥有多项具有自主知识产权的临床研究系列系统,经过众多项目实践,具备合规性、专业性及稳定性,能够助力临床研究高效高质推进。公司由顶尖专家领衔,拥有杰出的科学家顾问和优秀的技术团队,凭借卓越非凡的专业技术能力、精益求精的服务品质、经多见广的项目积累,赢得了合作方的广泛赞誉。 我们已经与多家国内外知名的生物医药企业建立了长期合作关系,服务的产品众多项被获批上市,我们将持续为合作伙伴提供优质的解决方案,促进全球临床研究发展!

Therapeutic Areas

  • Cardiovascular
  • Central Nervous System (CNS)
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Hematology
  • Hepatology
  • Immunology
  • Metabolic Diseases
  • Musculoskeletal
  • Neurology
  • Oncology
  • Ophthalmology
  • Respiratory
  • Rheumatology

Accreditations

Partners are trained on the functionality of the electronic data capture (EDC) and clinical data management (CDM) system, process optimization exercises and scope of Medidata Rave services. This Accreditation teaches the staff to perform end user training, user and site administration, study build, reporting, outputs and amendment manager.
Partners are trained on the functionality of the RTSM Application, process optimization, best practices using RTSM, and scope of RTSM services. This Accreditation teaches Partners to conduct randomization and clinical trial supply management services (RTSM). RTSM Accreditation is dependent on the successful completion of the Rave EDC Accreditation.