serviceBiostatistics

Our highly professional “biostatistics” team has the capacity to process vast amounts of data and can accommodate your needs.

Our professional experts with extensive experience deliver reliable data on the efficacy and safety of pharmaceuticals through precise implementation from statistical planning to final reports. Our ability to respond with flexibility to urgent requests, such as schedule changes and inquiries from regulatory agencies, ensures delivery of a high-quality product in an expeditious manner.

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Service Features

Point 1.
Project team of highly experienced professionals
Point 2.
Precise statistical plan through total study management to achieve goals
Point 3.
Efficient and high-quality analysis from academic experts and advanced SAS programming skills
Point 4.
CDISC-standard (SDTM, ADaM) compliant product

Main Services with Details

GCP and PMS

We prepare the following draft documents:

  • Statistical analysis plan
  • Specifications (e.g. diagram output specifications) and definition documents (e.g. analytical data)
  • Analytical programs and validation
  • Statistical analysis reports
  • Assistance in responding to inquiries from regulatory agencies
  • Consultations on overall biostatistics

GCP and more

  • Support for preparation of protocol (e.g. in relation to biostatistics)
  • Code-breaking meeting (e.g. immediate analysis result preparation)
  • Pharmacokinetics parameters calculation
  • CDISC-standard (SDTM, ADaM) data preparation
  • Comprehensive project management of clinical trials

PMS and more

  • Data confirmation materials
  • Preparation of research paper materials for publication

ADDIN EX(EDC system for post-marketing surveillance)

Our EDC System with speed, low cost and high-quality has been released

For more details

For further information onINTAGE Healthcare Inc.

If you have any questions or comments, please do not hesitate to contact us.

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INTAGE Healthcare’s Scope of Service