ICBio

ICBio is a full-service Contract Research Organization headquartered in Bengaluru, India. It serves pharmaceutical and biopharmaceutical companies, and the excerpts also list herbal/nutraceutical, medical device, and cosmetics and personal care clients.

Services

• Bioavailability and bioequivalence (BA/BE) studies, including PK studies in healthy volunteers and patient trials for generics and NCEs
• Clinical development services covering phases I–IV, with the excerpts describing phase II to IV support and phase 2 and 3 trials
• Bioanalytical research, with methods developed and validated for 200 molecules
• Biostatistics and statistical programming
• Regulatory services
• Pharmacovigilance, including ICSR, aggregate reports, signal and risk management, QPPV and PSMF support
• Medical writing and clinical data management
• Central laboratory services, described as integrated with LIMS

Capabilities and infrastructure

• Clinical unit established in 2014, described as having 132 beds in one passage and 100 beds in another, with 24/7 doctor and paramedical coverage
• Bioanalytical laboratory with LC-MS/MS, including SCIEX and Shimadzu mass spectrometers and a PerkinElmer ICP-MS
• Facility of about 20,000 sq. ft. with access control and UPS backup
• Network of 150 sites across 17 cities, plus a large volunteer and patient database

Quality and approvals

• The excerpts cite approvals from DCGI-CDSCO (India), ANVISA (Brazil), ISP (Chile), NPRA (Malaysia), MHRA, EMA, TGA, and several Middle East and African health authorities
• NABL and ILAC-MRA accreditation for the clinical laboratory, with GCLP compliance cited for the central lab
• ISO 9001:2015, ISO 15189:2012, ISO 14001:2015, ISO/IEC 27001:2013, and OHSAS 18001:2007 are listed
• The company states it follows ICH-GCP guidelines

Track record

The excerpts cite over 16 years of experience, more than 90 clients, 1,000+ BA/BE studies, and about 500 phase trials, with work reaching over 56 countries.