CTIS for sponsors of clinical trials
PVPHARM, a leading company in specialized pharmacovigilance and clinical safety services, has a group of experts that can manage CTIS on behalf of any clinical trial sponsor, and related tasks throughout the process, as well as train and support users who have not yet had the opportunity to familiarize themselves with this system

According to the ASEBIO 2021 report, the Spanish biotech sector invested close to 900 million euros in R&D in 2020, of which 67% corresponds to biotech companies.
Among the companies with exclusively biotechnological activity, 47% are dedicated to the area of human health. The biotech sector continues its fight against diseases such as Alzheimer's or cancer, to produce biopharmaceuticals, detect and diagnose diseases more quickly and accurately, as well as to produce vaccines and use other biotechnological tools for disease prevention and containing infectious diseases.
Clinical trials are a fundamental tool for the development of innovative drugs against diseases such as cancer, rare diseases, the central nervous system and dermatology, among others.
Sponsors of clinical trials in the EU should be aware that the EMA’s Management Board, on 31 January 2022 established a harmonized approach to submission, assessment, and authorization of clinical trial applications as well as reporting and supervision of clinical trials with the implementation of consistent rules throughout the EU Member States. These processes are supported by an EU portal and EU database which ensure a single-entry point with a workflow with monitoring and decision-making.
This new procedure is called CTIS, and its AIM is to:
- Be the single-entry point for submitting clinical trials information in the EU with the highest standards of safety for participants and increased transparency of clinical trial information.
- Support of authorities and sponsors processes throughout the life-cycle of a clinical trial through collaboration tools, workflow, and reporting and document management capabilities.
- Deliver an electronic Annual Safety Reports (ASRs) repository.
PVPHARM, a leading company in specialized pharmacovigilance and clinical safety services, has a group of experts that can manage CTIS on behalf of any clinical trial sponsor, and related tasks throughout the process, as well as train and support users who have not yet had the opportunity to familiarize themselves with this system.
If you want to know more about the Clinical Trials Information System (CTIS) and its key elements, here you can review a didactic summary from the European Medicines Agency or you can also visit PVpharm's website for further information: https://pvpharm.com/.