Quality Assurance

Quality Assurance
Clinical Development

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.

QMS design and Management Services:

  • Process Mapping
  • Document Management Process set-up
  • Identification and Development of Quality Policies and SOPs
  • Training on QA aspects
  • Gap identification and mitigation in established systems

Auditing Services:

  • GCP / GCLP, Part 11 compliance audits.
  • CDM and EDC audits
  • BA/BE study audits
  • Clinical Trial site audits
  • Mock inspections/pre-regulatory audits
  • Pathology lab audits (NABL/CAP)

21 CFR Part 11 Compliance Support:

  • Computer system validation services
  • Software validation QA services

Quality Assurance from ICBIO increases your chances of a positive audit outcome.

Quality Assurance is an essential stage in your clinical trial approval. Contact ICBIO today to find out

How our Quality Assurance department could improve your outcomes.

Business Enquiry Form

Copyrights © 2012 - 2017 ICBIO Corporation