Support of generic drug development|Service|SRD

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Support of generic drug development

Quality, Speed, Cost.
To provide you satisfaction in all, our monitors specialized in generic drugs will offer you a full service, from planning to the elaboration of summary report.

Our monitors specialized in generic drugs will provide you support during the entire development work, from the planning that is suitable for the developed items to the elaboration of summary report.

 

 

Model schedule

Model schedule

Service contents:

  • Site selection
  • Monitoring
  • Quality Control
  • Case registration / Drug allocation
  • Drug management / Storage
  • Data management / Statistical analysis
  • Medical writing (Various study related documents)
  • GCP Audit
  • Cooperation and support to the GCP compliance investigation (field work)
  • Consultant for Application work
  • Through the understanding of features according to dosage form, we will propose the appropriate study design.
  • We can propose a study design by maximizing our know-how such as the settings of the entry criteria of subjects, which is thought as a top priority for the safety of subjects, and the settings of an optimal blood sampling for obtaining valid data.
  • Our monitors specialized in generic drug development can flexibly and quickly provide support for clinical trials of various design or drug properties.
  • We are holding a "Customer satisfaction training" on regular basis, and we strive to always do a work for which everyone is aware of the needs of our customers.
  • In cooperation with the SMO which is a company of SRD group [MSR Co., Ltd.], the clinical studies can be carried out at low cost. Moreover, their presence in the same building will enable a quick support.
  • At each stage of the study, we are carrying out a high quality study inspection and QC check of documents/records relating to the study.