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.
Implementing an eTMF system is a significant undertaking, but with careful planning and attention to detail, it can greatly benefit your organization. By following this eTMF implementation checklist, you can set your organization up for success, improving efficiency, compliance, and overall management of clinical trial documentation.
By implementing a unified digital platform, organizations can realize numerous benefits in terms of efficiency, cost savings, data quality, and overall effectiveness. These advantages contribute to a more streamlined and successful drug development process, ultimately helping organizations bring new treatments to market faster and at a lower cost.
Financial transparency and timely payments are essential for maintaining strong relationships with clinical sites and ensuring their continued participation in trials. As the landscape of clinical research evolves, it is crucial for sponsors and CROs to adopt innovative solutions and strategies that address the challenges associated with clinical site engagement, particularly regarding payment visibility.
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.
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.
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 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.
Introduction: The new European Union (EU) Clinical Trial Regulation (CTR),
Clinical trials are an important part of the healthcare system,
Clinical trials are complex and resource-intensive endeavors, and as such,
21 CFR Part 11 is a regulation set by the
Chronic diseases such as heart disease, diabetes, cancer, and respiratory
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