How Navitas Life Sciences Facilitates Transition to the CTIS Portal

The Clinical Trials Information System (CTIS) is an innovative digital platform developed by the European Medicines Agency (EMA) to enhance the efficiency and transparency of clinical trials across the European Union (EU). The EU has implemented the Regulation 2014/536 as of January 31, 2022, so it is crucial for sponsors, investigators, and other stakeholders to ensure a smooth and successful migration process. In this blog post, we will explore how Navitas Life Sciences can provide valuable support and expertise in transitioning ongoing clinical trials to the CTIS portal.

How Navitas can help in transitioning ongoing clinical trials to the CTIS portal:

Navitas Life Sciences offers a comprehensive CTIS readiness assessment to evaluate an organization's preparedness for transitioning ongoing clinical trials to the CTIS portal. Our team of experts conduct detailed analysis of existing systems, processes, and data to identify any gaps or areas that require attention. By performing this assessment, a tailored strategy is developed to align your operations with the CTIS requirements, ensuring a seamless transition.

Transitioning to the CTIS portal requires careful planning and strategic execution. Navitas Life Sciences can assist in formulating an implementation plan that aligns with an organization's unique needs and circumstances. Our experienced consultants will work closely with you to develop a roadmap for migrating your ongoing trials, ensuring minimal disruption and maximum compliance. We will provide guidance on data migration, system integration, and regulatory compliance, helping you navigate the complexities of the CTIS implementation process.

During this transition, our experts can support seamless transition of the existing data to the CTIS portal.

Our experts can help you:

• Optimize clinical trial applications and evaluation procedures across the EU
• Enhance safety standards and expedite safety reporting.
• Develop a transition strategy that supports the needs and fits the application into CTIS

Implementation of transitioning trials in CTIS

Leverage our Expertise to Stay Updated

One of the key challenges in transitioning to the CTIS portal is the integration of existing data and systems with the new platform. Navitas Life Sciences specializes in data management and integration solutions for clinical trials. Our experts will assist you in mapping and harmonizing your trial data to meet the CTIS requirements. We can also facilitate the integration of your existing clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant platforms with the CTIS, ensuring a smooth flow of data and reducing manual effort.

Clinical trials are considered the most promising approach for introducing new drugs to the market. These trials involve assessing the safety and effectiveness of drugs on human subjects. The management and oversight of clinical trials have been implemented by individual member states and often influenced by various organizations.

A discrepancy between available resources for conducting trials and the organization overseeing them leads to challenges in several areas and reduction in efficiency. However, the introduction of the CTIS domain, a unified portal, addresses these shortcomings. One crucial step in initiating a Clinical Trial Authorization (CTA) is the submission of a comprehensive dossier that complies with EU regulations. This dossier preparation process requires substantial effort and expertise.

Our end-to-end clinical trial services provides a comprehensive solution to ensure efficient clinical trials.

Ensuring regulatory compliance and maintaining data quality are vital aspects of transitioning to the CTIS portal. Navitas Life Sciences has a deep understanding of the regulatory landscape and extensive experience in quality assurance for clinical trials. Our regulatory experts can guide you through the process of aligning your trial processes and documentation with the CTIS requirements, reducing the risk of non-compliance and data discrepancies.

As the CTIS portal becomes the central platform for clinical trial management in the EU, transitioning ongoing trials to this new system is a crucial step for sponsors and investigators. Navitas Life Sciences, with its expertise in regulatory compliance, data management, and technology solutions, can be a valuable partner in this transition process. By leveraging our comprehensive services, a seamless migration to the CTIS portal may be possible, enabling efficient management of ongoing clinical trials.

Preparing for the New Era: A Guide to Transitioning Clinical Trials to CTIS Regulation in the EU

Read the insightful article on transitioning to the CTIS portal authored by Bhuvaneswari Sivaraman, Regulatory SME, Regulatory Operations, Ragini Tushar Bhandari, Senior Manager, Regulatory Operations and Velkumar Kuzhandhaipandian, Senior Manager, Regulatory Operations and published in World Pharma Today on May 11^th 2023

Find out about

• What is the Clinical Trial Information System
• The Vital Prerequisites for Accessing the CTIS portal
• Key Benefits of Utilizing the CTIS portal
• Getting Authorization Right

...And More!

May 2023

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Bhuvaneswari Sivaraman

Regulatory SME, Regulatory Operations

Ragini Tushar Bhandari

Senior Manager, Regulatory Operations

Velkumar Kuzhandhaipandian

Senior Manager, Regulatory Operations