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Arrow Translation Life Sciences = Global Transparency (Updated 2024)
With the rapid development of the life sciences industry and the increasingly stringent global regulatory environment, the demand for transparency has become more urgent. Global medical consumers, regulators, and industry insiders are pushing for higher levels of transparency, especially in the disclosure of clinical trial data and post-marketing information for drugs. Patients, researchers, and the public all want more information about treatment effects, clinical trial results, and future R&D directions, and this demand has driven a new round of reforms on transparency and data sharing around the world.
The latest on transparency: 2024 edition
In recent years, global pharmaceutical and biotechnology companies have been actively adapting to emerging transparency requirements. With the policy updates of regulatory agencies such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), more and more countries require the disclosure and transparency of clinical trial data, research reports and post-marketing information of drugs, with the aim of increasing public trust in the drug development process and optimizing the patient decision-making process.
In 2024 , the global transparency requirements continue to strengthen. Most notably, the global clinical trial registration and data sharing platform (such as ClinicalTrials.gov) has been fully upgraded and requires all clinical trial data to be publicly released, especially after the trial is over. This applies not only to the drug development stage, but also to relevant data in the fields of vaccines, medical devices, etc.
In addition, many international pharmaceutical companies are gradually promoting internal transparency, such as making their clinical study reports (CSRs), clinical data, and research progress public so that the public, researchers, and patients can have a clearer understanding of the development process of treatment options.
Transparency regulations: the latest global policy
As the global demand for transparency increases, regulators are also constantly pushing for new policies. For example:
- European Union (EU) Clinical Trials Regulation (CTR) : This regulation, which will come into effect in 2022, requires that all clinical trial data conducted in EU member states must be made public within 12 months after the end of the clinical trial, and requires that clinical study reports (CSRs) be accessible on a public platform. This change marks the EU's positive advancement in clinical trial transparency.
- The US FDA's transparency policy : The FDA has also made further requirements for drug approval and the disclosure of clinical data. For example, the FDA has implemented the Clinical Trial Data Sharing Act, which requires all pharmaceutical companies to disclose their trial data and results to the public and researchers in a timely manner after the completion of clinical trials.
- Global Drug Data Sharing Initiative : In 2024, several global industry organizations jointly launched the Global Drug Data Sharing Platform , which aims to improve the transparency of the drug development process and share all trial data and research results about drugs. Pharmaceutical and biotechnology companies are also encouraged to provide clinical trial data from multiple countries and regions to ensure that global patients and healthcare providers can obtain timely and reliable information.
New challenges for global transparency: language and localization
Although significant progress has been made in the transparency process, many challenges remain, especially in terms of communication and information sharing across languages and cultures . Many pharmaceutical companies have not yet considered how to provide information to research subjects and patients around the world, especially patient populations in non-English-speaking countries.
For example, clinical study reports (CSRs) and other clinical trial data are often published in English, but most patients and study participants in non-English-speaking countries also require localized versions of this information. How to ensure the effective dissemination of information on a global scale has become an important issue faced by enterprises.
Arrow Translation’s solution: cross-language transparency
As the pace of globalization accelerates and the need for cross-cultural communication grows, Arrow Translation helps life science companies meet increasingly stringent transparency requirements through its advanced language services and localization solutions. Our cross-language translation and localization services not only provide accurate language conversion, but also ensure that information can be consistently and effectively delivered around the world.
Here are some of the services and support Arrow Translation provides to life science companies to help them successfully address the challenges of transparency:
- Global Clinical Study Report (CSR) Translation and Localization
Arrow Translation helps life science companies translate and localize clinical study reports (CSRs) so that they can be accurately communicated to subjects and patients in different regions around the world. We have a professional medical translation team to ensure that all medical terms and industry terms are accurately expressed in various languages, ensuring that patients, doctors and researchers can fully understand this key information. - Cross-language data sharing platform
In the context of the global drug data sharing platform, Arrow Translation supports pharmaceutical companies' needs for transparency in different languages and regions, helping them effectively manage the localization and sharing of clinical data. Our platform can not only process clinical data in various formats, but also support translation and optimization in various languages, ensuring that users around the world can easily obtain the information they need. - multilingual
social media management services to ensure that information is released in accordance with the cultural habits and language characteristics of each market, while increasing public attention and recognition of the company's transparency efforts. - Global Compliance and Legal Document Translation
As regulatory requirements continue to change, life science companies must ensure that all their research data and clinical reports comply with legal and compliance requirements around the world. Arrow Translation provides professional legal document translation services to help companies ensure that all documents they publish comply with local regulatory requirements and avoid compliance issues caused by language or cultural differences.
Prepare in advance for a global transparent future
In 2024, as transparency policies continue to advance, the global life sciences industry will face stricter information sharing and data disclosure requirements. Companies need to be fully prepared in terms of global data sharing , localization , and cross-cultural communication to cope with the increasingly complex global market.
Arrow Translation provides comprehensive support to pharmaceutical companies by providing global transparency solutions , ensuring that they can quickly adapt and communicate effectively in this new global environment. Whether it is translation, data localization, or social media communication, Arrow Translation's expert team can provide strong support to life science companies to help them establish a reliable and transparent brand image around the world.
Through the TransParency program , Arrow Translation provides professional consulting services to global life science companies to ensure they can adapt to new regulations and policy requirements, helping them stay ahead of the global wave of transparency.