Life Sciences

LIFE SCIENCES @IT MINDS

Unparallel Understanding Of The Life Science Industry

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.

Our commitment to delivering efficient and practical end-to-end solutions is unparalleled. With our HIPAA, GXP, CSV, 21 CFR Part 11 compliance, and other applicable regulatory guidelines, we are able to provide the best solutions in the industry. Our unmatched domain experience and technology expertise enable us to deliver superior solutions. Contact us today to learn more about how we can help you achieve your life science goals.

Empowering Clinical Operations in the Post-Pandemic Era

Clinical Operations

Addressing Challenges, Enhancing Outcomes

In the Post-Pandemic world, medical trials face the challenge of growing expectations of compressed timelines, more complex study protocols, increased regulatory expectations, and the dynamic nature of emerging technologies and industry standards, putting increasing strain on Clinical Operations.

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.

Regulatory Affairs

Like many other facets of the medical industry, Regulatory Affairs have become more difficult and challenging since the emergence of the COVID-19 pandemic. New technologies and shrinking time frames have put even more pressure on creating complex rules and regulations to govern the protean nature of product development in the medical industry.

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.

Ensure Compliance and Efficiency with IT Minds

Drug Safety

Navigating Complex Drug Safety Regulations

Under the scrutiny of bodies such as the FDA, EMA, and PMDA, continued pressure is being placed on Drug Safety to track adverse events correctly in accordance with ever-changing regulations, making it progressively more difficult to remain vigilant and effective in regard to drug safety.

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.

Quality & Compliance

With the growing complexity of relevant protocols for clinical trials, it is becoming increasingly difficult to find and maintain research staff with all the necessary up-to-date training for current regulatory requirements, leaving concerning vulnerabilities in the clinical trials process.

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.

Streamline Your Drug Trial Validation Process with IT Minds

Clinical Validation

Streamlining Drug Trial Validation: Enhancing Transparency and Compliance

Concerns regarding the transparency in the data collection and validation process of drug trials have led to further pressure on companies from the FDA. Although safety is an integral part of Drug Trial Validation, it is becoming increasingly difficult to assess data and correctly plan assessment.

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.

Always delivering quality solutions

IT Minds has extensive experience and high-quality tools to help you stay competitive in the digital age.

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