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IT Minds has an unparallel understanding of the life science industry. We specialize in clinical trials, data warehousing, drug safety, eTMF (electronic trial master file) for Pharma, Pharmacovigilance, Biotech, and CROs.
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IT Minds can help you deliver better quality trials and Clinical Outcomes for your clinical operations. We will provide expert insight into Protocol Development, providing the Study Design that best encapsulates your aims. To keep your data integrity, we provide quality eCRF setup and experts trained in ICH/GCP and ISO protocols for optimum trial monitoring outcomes.
IT Minds provides extensive support for your Regulatory Needs. As a skilled and experienced team, we can assist you with Regulatory Strategies, e-Submissions and Gap Analysis, providing you a superior solution to the management of the life-cycle of your product.
IT Minds can help your company remain effective in Drug Safety, offering expertise in the Submission, Reviewing, Cleansing, and Migration of Data, whilst providing SAE Reconciliation. With a strong grounding in IDMP, Compliance Tracking, and Quality Tracking, we can help you deliver adverse events reports to the authorities with confidence.
IT Minds have the knowledge and expertise to plan, revise or implement your Quality Management Systems. From QMS documents like SOPs, we can help you achieve a better understanding of what is needed for each project by providing risk-based advice on an individual level which will result in more efficient use within companies’ operations.
IT Minds can help you efficiently and credibly enact your Drug Trial Validations with a deep understanding of the Pre-Validation phase, the Validation Execution phase, and the Validation Maintenance Phase. Whether preparing QMS documents or the Analytical Method Qualification study, we can help you make your validation process as speedy and accurate as possible.