Quality Assurance

Quality Assurance

Quality management provides quality systems which in turn guarantee good quality data in each clinical trial. Quality systems implemented at ICBIO and managed by Quality Management ensure the quality, integrity, and accuracy of data for each clinical study undertaken at ICBIO.

Our Quality Assurance (QA) team which independently audits clinical, bioanalytical, PK & statistical activities, for ensuring quality and integrity of data generated and ensures compliance to Protocol, SOPs, GCP, GLP and other regulations. This team ensures the adaptation and implementation of the best practices and processes in the industry.

Our Quality Assurance department also coordinates training of Clinical Research staff to ensure constant improvement.

ICBio has well established Quality management system with well-developed procedures and policies to ensure protocol adherence and compliance with International regulatory guidelines. We have competent Quality professionals with hands-on experience in GCP and ISO systems.

ICBio's QA team has experience in QMS setup, auditing and software validation assignments. Our auditing experience includes USFDA, UKMHRA, EU, ANVISA, MCC submission studies.

ICBio's QA team has successfully faced USFDA, UKMHRA, MCC, ANVISA inspections.

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Departments

Quality Assurance
Quality management provides quality systems which in turn guarantee good quality data in each clinical trial. Quality systems implemented at ICBIO and managed by Quality Management ensure the quality, integrity, and accuracy of data for each clinical study undertaken at ICBIO.

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Clinical Development
Clinical Development team conducts Phases II-IV clinical trials for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. A team of well-trained professionals, experience in project management in various therapeutic areas.

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Bio Analytical
ICBio management & operations team brings in considerable experience in conducting BA/BE studies on healthy as well as patient population with various dosage forms including injectables like IM/IV/SC, oral dosage forms like solid formulations (Modified Release preparations), liquid formulations, topical preparations and inhalations. The BA/BE studies conducted at ICBio are fully GCP compliant.

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Project Management
ICBIO's project management group stands out from other CROs in an industry where hard deliverables and quality of enrollment are everything. ICBIO project managers throughout the globe are obsessive about on-time project delivery from day one.

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Biostatistics
Our focus is to ensure the integrity of your data and organize your findings and conclusions into a clear and results-oriented presentation. Our bio statistics for clinical research and statistical programming services include pre-analysis, analysis and post-analysis.

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