Quality Assurance

quality assurance in clinical trials

Quality Assurance

Biosphere appoints a well-experienced Quality Assurance team to ensure that all rules and regulations are being followed. We monitor the stringent Standard Operating Procedures (SOPs) for every step of the clinical trial.

For Quality assurance in pharma (Clinical research), International Conference on Harmonization – Good Clinical Practice ICH – GCP is the international quality standard followed by the industry. These practices are used across the world to understand the risks underlying a proposed trial, to evaluate the data for quality and accuracy, to ensure ethical project processes and for checking project adherence to regulatory frameworks.

For quality assurance in clinical trials, we keep track of the usage of best practices by team members through regular audits. Biosphere supports project sponsors with audit reports at regular intervals for their clinical trial projects worldwide. Our team gives an elaborate report on the areas of the trial that need attention for the trial to be successful.

Service Offered

  • Timely audits by quality experts from our Quality Assurance (QA) team.
  • Data checks through our unique remote monitoring solution by e-Prudent.
  • Quality Assurance services can be provided independently or as part of a customised comprehensive solution.

Benefits

  • Sponsors can run ethical clinical trials by following Good Clinical Practices (GCP) with the support of our qualified Quality Assurance team for clinical trials.
  • The audits help to protect confidential data related to identity of the patients and other important trial details.
  • The reports of the QA team verifies the credibility and accuracy of the data utilised for conducting the trial.

Speak to a member of our team about our clinical and safety data services

Our expert will work with you to gain insight to your molecule, anticipated outcomes and definite trial requirements and provide a customised design best suited for your molecule.

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