Bestudy

Bestudy provides services on the Design, Organization, Operation and Management of phase I to IV local and global multicenter Clinical Trials for innovative drugs and medical devices. These include but not limited to project plan and preparation, IND/NDA, protocol writing, site selection and initiation, clinical monitoring, project management, quality control, Medical Review, data management and statistical analysis, Clinical Study Report writing, self-inspection/ inspection support/3rd party audit, etc. Bestudy also deliver pharmacovigilance services in clinical study phase and post-marketing phase, and in Post-marketing Intensive Drug Monitoring studies. In addition, Bestudy provides regulatory consultancy services and agent service for drug and medical devices, consultancy services for Chinese market entry of foreign products, HEOR and market entry. We also provide technical and professional training for investigator and the professionals in industry.

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Locations

  • APAC

Therapeutic Areas

  • Anesthesia
  • Bone / Osteoporosis
  • Cardiovascular
  • Dermatology
  • Diabetes
  • Diagnostic reagent
  • Gastroenterology
  • Hematology
  • Immunology
  • Infectious Diseases
  • Medical Devices
  • Metabolic Diseases
  • Nephrology
  • Nutrition and Health
  • Oncology
  • Ophthalmology
  • Psychiatry
  • Respiratory
  • Urology

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.