In today’s post, we’ll tell you about what CTIS Clinical Trials, Clinical Trials Information System are, how they work, what their benefits are and the way this European Union’s Clinical Trials platform will change the pharmaceutical sector starting in 2023.

This a very comprehensive and interesting guide for researchers, pharmaceutical companies, health regulators or patients in general who are interested in learning about these important technological advances in the healthcare sector.

We invite you to continue reading…

What are CTIS Clinical Trials?

CTIS is the acronym for Clinical Trials Information System, a new EU clinical trials database and portal, developed to harmonize the application, evaluation, and monitoring of clinical trials in the European Economic Area (EEA). Promoted by the European Medicines Agency (EMA).

How does CTIS work and what is it for?

The CTIS platform, Clinical Trials Information System, uses a centralized data management system that is responsible for collecting, storing, and analysing clinical trial data from multiple sites and sources.
This allows researchers, pharmaceutical companies and healthcare regulators to access data in real-time and make informed decisions about the development of new drugs and treatments.
CTIS is designed to integrate with different clinical trial management systems and other research tools, increasing the accuracy and reliability of results and transparency.
Also, thanks to artificial intelligence and real-time data analysis, it is possible to identify patterns and trends in the data obtained from clinical trials, which increases efficiency by identifying potential problems.

With which technology is the CTIS Clinical Trials platform developed?

The CTIS platform is developed using modern information and communication technologies.
It includes data management software, artificial intelligence systems and real-time data analysis.

CTIS Clinical Trials Information System (CTIS) Benefits

1. Safety and efficacy

CTIS platform’s main benefit in the health sector is the accurate tracking of participants in clinical trials, which ensures that the data collected is reliable and accurate.

2. Speed

A CTIS system can help to identify problems faster and thus helps researchers to reduce risks and improve the efficiency of each clinical trial.

3. Cost reduction and time savings

Collecting and managing data in multiple systems can be very expensive as errors and delays increase costs.
Thanks to the CTIS platform and its integration with different systems, centralized data is obtained and time and money can be saved on these tasks.

4. Fewer errors

The CTIS systems integration technology avoids duplicated efforts and minimizes mistakes when managing clinical trials.

5. Teamwork

As a centralized system, CTIS allows researchers, regulators and other stakeholders involved in drug and treatment development to collaborate and work together effectively.

6. Process optimization

Approving and reviewing data analysis processes in clinical trial management are key factors in clinical trials. Thanks to the CTIS platform technology, these processes can be optimized and accelerated, which also reduces associated costs.

7. Information for patients

The CTIS platform will allow patients to be aware of the different clinical trials taking place in the European Union.

Who created the CTIS platform and why is it so important for the pharmaceutical and healthcare sector?

The CTIS platform, or Clinical Trials Information System, was created by the European Medicines Agency (EMA) and developed by NTT DATA, a Japan-based information technology company.
It was developed in collaboration with different stakeholders in the healthcare sector, such as regulatory authorities and others from the pharmaceutical industry.
The EMA is the European Union agency responsible for the scientific evaluation, supervision and safety of medicines used in the EU and contracted NTT DATA to provide technical support and to develop the Clinical Trials Information System (CTIS).
Clinical trials are a very important and crucial part of the process of developing treatments and new drugs in the pharmaceutical sector, which is why the CTIS platform has been created to improve how clinical trials are regulated in the EU.
It should be mentioned that when clinical trials are carried out effectively they validate that the drug being used is safe for a specific treatment.
Many times these trials may have difficulties in their collection due to the large amount of data that must be promptly and safely analysed.
In addition, data collection can be complicated and susceptible to human error, which can affect the quality of the data, so it is important to manage the information through a platform such as CTIS to ensure reliability.
The CTIS platform enables effective, efficient and transparent clinical trial management for the pharmaceutical industry and, in general, for the health industry.

When was the CTIS Clinical Trials Information System created and how can it be used?

The CTIS platform became operational on January 31, 2022 and is currently in a transition period as part of the new European Regulation for the pharmaceutical sector.
All clinical trial applications will be accepted by March 2023 and can be submitted to the system through the CTIS platform on the official Clinical Trials website.
This regulation will allow single applications for trials performed in different countries of the European Union.
It is expected that by 2025 all these incoming clinical trials will be transferred to the CTIS system, which will ensure new standards and will harmonize the management system across the European Union through the Clinical Trials website.
As time goes on, the data available for public searches will increase and this will contribute positively to innovation and research in the healthcare sector, because it will allow users to obtain information about approved clinical trials.

In which language are clinical trials submitted to the CTIS platform?

According to European Union regulations, clinical trials must be submitted to the CTIS platform in English.
This is because English is the official language of the European Union used for technical communication and documentation.
However, some additional documents can be submitted in other languages, if they are accompanied by a certified English translation.

At Norak Group, we have created the division Norak Pharma to support the pharmaceutical and healthcare industry in their communication needs in the official languages of each local or supranational authority.

Norak Pharma is a division of Norak Group and has over 25 years of experience in providing linguistic solutions to the life sciences sector, which includes pharmaceutical companies, Biotech companies, Medical Devices companies and other healthcare companies.
Norak Pharma’s specialized pharmaceutical translations and solutions help pharmaceutical and healthcare companies to achieve their goals faster.
In addition, we also have Information Security Systems to ensure confidentiality at all times by working in secure environments that guarantee data integrity and confidentiality.
Clinical trials represent a big challenge for our clients and partners when they need urgent translations.
That is why we ensure our services are as flexible as possible to meet each requirement and work with state-of-the-art technologies.
We know that clinical trials are complex and demanding! So once we receive the original documents, we review them and recommend the best translation approach or method for the project.

Click here to learn more about our linguistic solutions for the pharmaceutical industry.

Do you want clinical trials or other high-quality pharmaceutical translations to be translated?

Click here and contact us so we can advise you.

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