Facility

Facility >> Biostatistics and Data Management

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

Updates
Indoco's Clinical Research Organisation – AnaCipher receives accreditation from UKMHRA AnaCipher CRO receives BE study approval from NPRA-Malaysia in July 2021, through a desk assessment review process. The review process involved all the phases of the study. 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
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