Dinesh Kashyap


Dinesh is a distinguished visionary leader with more than 20 years of experience in the IT industry. He has an impressive track record in strategy and management consulting, business & IT transformation, innovative digital platform implementations, building practice and capabilities in new niche markets. Prior to founding Cloudbyz, Dinesh was with HCL where he led a multi-million dollar business. You can find Dinesh on LinkedIn.

Preparing for the New EU-CTR: A Step-by-Step Guide and SOPs for Compliance

The new EU Clinical Trial Regulation replaces the previous Clinical Trials Directive and aims to improve patient safety and enhance transparency in clinical research. This article provides a step-by-step guide for preparing for the new Regulation, including understanding the changes, reviewing current clinical trial protocols, assessing the impact on your trial, developing new documents and procedures, training staff, preparing for centralized authorization, ensuring transparency, and staying up to date with new guidance. Additionally, the article suggests several Standard Operating Procedure (SOP) documents that could help adhere to the new Regulation, including Protocol Development SOP, Informed Consent SOP, Data Collection and Reporting SOP, Centralized Authorization SOP, End-of-Trial Reporting SOP, Training SOP, and Quality Control and Assurance SOP.

Accelerating Time to Market: Why Biotechnology Start-ups Must Utilize Midsize CROs

Midsize CROs offer a range of benefits for biotechnology start-ups looking to accelerate their time to market. By offering cost-effective collaboration, personalized attention, specialized expertise, streamlined communication, and a flexible and adaptable approach, midsize CROs can help start-ups develop their products more efficiently and effectively. By partnering with midsize CROs, biotechnology start-ups can increase their chances of success and bring innovative solutions to market faster.

Process Automation in Medical Device Safety Operation: Best Practices

Automating medical device safety tracking, assessment, adjudication, and regulatory reporting can help to streamline the process, reduce errors, and improve patient safety. It involves defining the workflow, identifying the software requirements, selecting the right software, integrating the software, implementing automated workflows, monitoring and evaluating the system, and updating the system as needed.

Integrating ESG in Drug Development Strategy for Pharmaceutical Companies

Integrating ESG factors into drug development strategy is critical for pharmaceutical companies seeking to meet the evolving expectations of stakeholders, foster innovation, reduce risk, and create long-term value. By understanding the key ESG factors relevant to drug development and following a comprehensive framework for ESG integration, pharmaceutical companies can optimize their drug development processes, leading to more sustainable and equitable outcomes. In doing so, they can enhance their reputations, generate long-term value for their stakeholders, and contribute to a healthier and more sustainable world.

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At Cloudbyz, our mission is to empower our clients to achieve their business goals by delivering innovative, scalable, and intuitive cloud-based solutions that enable them to streamline their operations, maximize efficiency, and drive growth. We strive to be a trusted partner, dedicated to providing exceptional service, exceptional products, and unparalleled support, while fostering a culture of innovation, collaboration, and excellence in everything we do.


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