“WE UNDERSTAND

YOUR VISION ON HEALTHCARE

AND WE DO CARE

YOUR MISSION ON RESEARCH”

ICBio CRO - A Preferred Clinical Research Organization,

ICBio engaged in conducting Bioavailability and Bioequivalence studies and
Clinical Trials Phase I– IV for the Domestic and Global Pharmaceuticals,
Nutraceuticals, Cosmetic industries.

we also conduct safety and efficacy studies on Herbal, Personal care & OTC Products.

Inspected & approved by

Drug Controller General of India,
Ministry of Health - Kazakhstan
In house R&D Centre Recognised by DSIR
NABL accredited / Certified Central Lab

Accreditation & Certication in process:

National Pharmaceutical Regulatory Agency, Malaysia.

www.icbiocro.com
About us
ICBio Clinical Research, a leading Contract Research Organization (CRO) providing integrated clinical
offerings in Early Phase, Late Phase (Phase II-IV), Bioavailability / Bioequivalence (BA/BE) studies,
Clinical Endpoint Studies, Bioanalytical, and serving to Pharmaceuticals, Biotech, Nutraceuticals &
Herbal, Cosmetics, Personal care and OTC Product domains.

Our facility is spread on 20,000 sq.ft and the full-fledged state-of-art facility in Bangalore, India, enables the
Sponsor to conduct bio-availability and bio-equivalence studies in compliance with 21 CFR.
Ø Drug Controller General of India (DCGI), CDSCO approved BA/BE facility
Ø Regulatory compliance with the latest GCP, GLP and 21 CFR (part 11) and applicable
BA/BE guidelines
Ø NABL accredited Clinical and Diagnostics Laboratory
Ø DSIR recognized in-house R & D
Ø 10,000 volunteer data base and VIMS software for volunteer management
Ø 24 bedded facility with fully access-controlled state-of-art and UPS back-up
Ø Exclusive strategies in place to strive for 100% subject turn-out to cover the complete
sampling schedule
Ø LC-MS/MS 8040, LC-MS/MS 8050 (Shimadzu), PerkinElmer's NexION 1000 ICP-MS and
Validated bioanalytical method for 125 molecules
Ø Method Development & Method Validation of a molecule within 2-3 weeks
Ø Completion of BE study within 3.5 months.
Ø Network of 150 hospitals and expertise in 18 therapeutic areas to conduct clinical trials:
Phase I to IV.
We are proud of our excellent track record serving over 50 clients, with the achieved competencies of
Ø Regulatory compliance Ø Operational Excellence
Ø Highest quality Ø Client-specific focus
Ø Economic budgets Ø Flexible working culture
Ø Time-bound deliveries Ø Customer satisfaction

We are driven 24x7 by the passion that ignites the inspiration every day and our inspiration comes from our
clients. We are grateful to our clients, who have shown faith in us to launch their products in the regulated,
semi-regulated and other markets.

We invite you to audit our facilities and look forward to experience our value-added services.

Team ICBio

End - to- - end CRO

MC-2456 NABL Accredited Laboratory

Functional CRO

ICBio Clinical Research Pvt. Ltd. www.icbiocro.com

 Services Offered
ICBio has the expertise needed in a CRO partner to ensure the quality in conduct of Bioavailability /
Bioequivalence studies and Clinical Trials.

CLINICAL TRIALS OPERATIONS BA / BE STUDIES:

Clinical trials are a part of Drug Development. Our expertise in conducting the following types of
ICBio offers end-to-end services for Phase I to IV studies
clinical trials on small molecules, large molecules
and medical devices with fully ICH GCP compliant Healthy Volunteer studies
operations. Ø Fasting and Fed condition studies
Ø Single and multiple dose
Phase 1 Human Pharmacology Studies Ø Drug-drug interaction
Ø Dose Tolerance Studies Ø Oral Inhalation – Pulmonary deposition &
Ø Single and Multiple dose PK / PD studies Therapeutic Equivalence Study
Ø Drug Interaction Studies

Patient based studies

Phase 2 Clinical Trials,
Therapeutic Exploratory Studies We have team of experienced professionals and an
Ø Dose-response exploration studies
network of Clinical Trial sites across India to offer
Ø Dose Ranging Studies the patient based BE studies with Pharmacokinetic
and Clinical end-point studies, we have Specialized
Phase 3 Clinical Trials, team for patient pharmacokinetics Studies.
Therapeutic Confirmatory Studies
Ø Well controlled studies to establish efficacy Project managers and CRAs experienced in
Ø Comparative Studies, Randomized parallel planning, executing Clinical endpoint studies,
dose-response studies Pharmacokinetic studies in patient population and
Ø Clinical safety & efficacy studies Phase II / III studies
Ø Large sample trials
FORMULATIONS:
Post Marketing Surveillance study (PMS)
Ø Solid Oral Formulations & Orally Dispersible
Customised Services Formulation: Tablets (Immediate Release &
Ÿ Site Management Modified Release e.g. ER, DR, SR), Capsules,
Ÿ Project Management and planning Soft Gels etc.
Ÿ Study Monitoring Ø Liquid Formulations
Ø Suspensions, Syrups & Dry power
Ÿ Regulatory Affairs
Ø Oral Inhalation
Ÿ Medical Writing,
Ÿ Bio-statistics & Clinical Data Management

ICBio Clinical Research Pvt. Ltd. www.icbiocro.com

Why to choose ICBio
Ø Approved by Drug Controller General of India (DCGI).

Ø Approved by Ministry of Health – Kazakhstan.

Ø NABL accredited Clinical Laboratory.

Ø DSIR Approved In house R & D centre, Govt. of India.

Ø Certifications ; ISO 9001:2015, ISO 15189: 2012, ISO 14001:2012, ISO 27001:2005.

Ø 21 CFR and ICH GCP Compliant Regulatory Systems and Procedures.

Ø Vast experience in conducting BE studies for various products and national &
international markets.
Ø Dedicated Project Management Resources for each client.

Ø Flexible working hours for global clients.

Ø Wide Pan India network of hospitals and Investigators- 150 sites in 17 different
cities with 18 plus therapeutic areas.
Ø Dedicated Project Management Team for each client.

Ø Diverse patient population database.

Ø Cost effective budgets.

Ø Rapid Turn Around Time.

Ø On Time Project Delivery.

ICBio Clinical Research Pvt. Ltd

#16 & 18, ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura,
Bangalore - 560 097, INDIA
Tele Ph.: +91 080 23641042 / 080 23641043,
Direct: +91 080 236441033
Mobile: +91 99001 11997
Email: info@icbiocro.com.
info.mail@icbiocro.com
Web: www.icbiocro.com