Facility

Facility >> Biostatistics and Data Management

  1. Experienced and experts of Pharmacokineticists and Biostatisticians
  2. Pharmacokinetic and Statistical Analysis are performed through Phoenix WinNonlin (Version 8.1) and SAS software's (Version 9.4), Global Use
  3. Dedicated team of data associates and managers to prepare the clinical study reports according to ICH-E3, eCTD and other regulatory submissions
  4. Team has hands on experience with InForm and Oracle clinical database
  5. Data Management using in-house Oracle Clinical Version 5.1

Updates

  AnaCipher CRO receives BE study approval from WHO in March 2020, through a desk assessment review process. The review process involved the Clinical & Bio-analytical phases of the study.
   Indoco's CRO – AnaCipher receives EIR from USFDA
   Indoco's Clinical Research Organisation receives zero 483s from USFDA
   Indoco's CRO – ANACIPHER clears USFDA inspection with ZERO 483
  Conducted internal training on “21 CFR Part 11” on 19th Jul 2019.
  Conducted external training on “ICH-GCP” on 29th Jul 2019

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