Clinical Trial Localization

Listen to this article now: The world of healthcare is rapidly evolving, with groundbreaking discoveries and advancements constantly reshaping the landscape. Clinical trials are at the forefront of these developments, serving as a critical bridge between scientific innovation and patient care. However, for these trials to truly benefit all individuals, it is essential that they …

Advancing Healthcare Equity through Inclusive Language in Clinical Trials Translation Read More »

Listen to this article now: Clinical Outcome Assessments (COAs), regardless of their type (Patient Reported Outcomes – PROs, Observer Reported Outcomes – ObsROs, Clinician Reported Outcomes – ClinROs, or Performance Outcomes – PerfOs) have placed patients in the center of clinical trials. How a patient feels, functions, or survives is a differentiating factor, influencing the …

How to Avoid COA Source Revisions and Their Impact on Translation Read More »

Listen to this article now: The European Union (EU) Clinical Trials Regulation (CTR) brings significant changes to the landscape of clinical research within the EU. With the aim of streamlining and harmonizing the regulation of clinical trials, the EU CTR imposes new requirements on documentation and transparency. In this context, accurate and reliable translations play …

Ensuring Compliance and Clarity: EU Clinical Trials Regulation and its Impact on Language Translations Read More »

Listen to this article now: In clinical trials, Clinical Outcome Assessments provide the necessary data to assess patients and their conditions. Nowadays, such assessments are performed more and more in electronic platforms, so any paper versions of the questionnaires, also known as paper scales or instruments, need to be migrated in an electronic format. But …

Six Challenges You Might Come Across during eCOA Migration Read More »

Listen to this article now: A Clinical Outcome Assessment, or “COA”, is a measure that provides a rating or score to assess patients’ health status. These assessments define efficacy endpoints when developing a therapy for a disease or condition. Their basic characteristic is that they may be influenced by human choices, judgment, or motivation, but in …

What is a Clinical Outcome Assessment? Read More »

Listen to this article now:   Creating clinical trial documentation in multiple languages can be challenging. To ensure compliance with regulations, the translation of clinical documents such as Informed Consent Forms (ICFs) and Clinical Outcome Assessment (COA) measures needs to be conceptually equivalent to the original text and culturally adequate for the intended audience. Back translation …

The Importance of
Back Translation in Clinical Trials Read More »

Listen to this article now:   The arrival of COVID-19 and researchers’ feverish quest to find a vaccine made the entire world aware of the need for global cooperation in clinical trials. Through that cooperation, the important role that language translation plays in clinical trials became even more evident to pharmaceutical companies and healthcare professionals …

Why is language translation so crucial in clinical trials? Read More »