Translating Documentation and Communication in Clinical Research - Virtual Conference

• Knowing the local terms for your documents
• Make sure the original text is reviewed and approved before translating to avoid disruption
• Preparing the translated documents in advance is key for the LSP to translate it correctly and within in the time frame

With a focus on improving and increasing diversity in clinical trials, we know we must move beyond gender, age, and race, to include ethnicity.

In this presentation you will learn:

• Barriers to participation in minority populations

• The impact of lack of diversity in RCTs

• How translations play a large part in overcoming the barriers

• Ensuring your clinical team understands the universal language internally
• Identify your clinical team’s language considerations in order to prepare your documents in advance

• Key Drivers for Successful Regulatory Submission
• Best Practices and Proven Ways to Break Language Barriers
• Patient Centricity

• Hurdles of biosimilar labeling translations for  EMA CPs

• Translation of labeling for drug-device combination products

• Key drivers for adopting new models
• Integrating technology to drive translation agility
• Best practices to accelerate projects and optimize budgets

• Revising current guidelines to ensure you are updated
• Analyse the regions of your clinical trial to develop a regional terminology bank to ensure your site team/patients understand the instructions
• Having non-professional review your instructions of use before submitting to avoid any delays of approval

• Overview of AI-enabled translation services and custom, trained engines for clinical study content.
• How MT systems are integrated with other translation tools, such as terminology and translation memory.
• The integration of technology solutions, including ISO-certified MT post-editing, for cost savings and faster turnaround times.
• What are the risks and how to implement solutions to minimize those risks.

• Ensuring that the correct terminology is used across all languages for patient safety
• Creating an initial and back translating framework as this will avoid any potential confusion
• Applying simple language techniques for the patient as this will help them use the product more effectively

• Translating for the lived patient experience in healthcare research
• Accounting for cross-cultural differences in patient education and the healthcare environment
• Maximizing cognitive interviews: let your participants’ data speak

• Analysing past trial instructions to see what worked and what didn’t
• Evaluating what tools and technology are out there to help deliver a clearer message to the patient
• Providing better information will allow a better outcome for your trial

• Native Speakers? Checking and confirming that the translator is a native speaker
• Having your documents prepared and ready in advance as this will help prevent delays

• Evaluating the document prior to translation to make sure there isn’t any issues
• Exploring the right, the services for translation to ensure they have the right qualifications
• Once translated, ask your team member to review the terminology in the document to identify any mistakes

• Establish PLS template for supporting consistent, clear communication incorporating key health literacy principles.
• The best written PLS documents use active voice, shorter sentences, and avoid the use of parentheses and other complex symbols that prepare sponsors for better translations.
• Use of graphics in PLS in facilitating universal comprehension that supports effective translations.

• Knowing what tools that are there to help develop your instructions and label designs
• Reviewing the written text from multiple parties will help identify errors
• Allowing adequate space for different languages as they can be longer than the original text

• Keeping a copy of your document in every language will help speed up any amendment process
• Forecasting potential updates in advance to allow your team time to prepare the translations
• Assessing any terminology differences in languages to prevent any legal ramifications