Clinical Investigations
& Trials
Specific Ways We Can Help.
Clinical trial protocols
- We support protocol development by helping you to communicate with international patient groups, and translate the resulting documents. We implement our custom AI to isolate and translate updates rapidly and accurately across all languages.
Patient recruitment materials
- We localize your recruitment and retention materials to resonate locally with a diverse range of global participants.
- We offer voiceover and subtitling, as well as an in-house DTP service.
Informed consent forms (ICFs)
- It’s essential that all participants fully understand what they are agreeing to and the potential effects. But cultural and linguistic factors can affect how different people receive the same information. Our linguists are experts with decades of experience translating ICFs for accuracy and effect.
Patient information leaflets (PILs)
- PILs provide guidance on how to use a device safely and effectively. As with ICFs, they must be understood by device users with total, unambiguous clarity. This is why PILs need to be translated – for the safety of all trial participants, and for regulatory and marketing authorization purposes.
Investigator brochures (IBs)
- We provide expert technical translation to ensure investigators in all locations know everything they need to know about the device being tested.
eCOA/ePRO
- Our combination of process experts, specialist linguists, and custom AI allows us to streamline the eCOA process and reduce timelines dramatically.
Regulatory documentation
- We can translate your regulatory documentation so it’s suitable for submission to all major international bodies, and have developed many AI tools over the years to facilitate the regulatory translation process.
Lay summaries
- Our expert linguists can help you translate lay summaries so they’re accessible to participants of all language backgrounds, cultures, and health literacy levels.
Tackling the Challenges of Clinical Investigations and Trials.
This stage of the lifecycle comes with a set of specific challenges, not least of which is the need to recruit and retain trial participants. This is one of the trickiest parts of the lifecycle, and is where a lot of devices stall, before their potential can be fully explored. We help widen and diversify the pool of participants, working with in-country linguists to ensure recruitment and retention materials engage local communities and push trials forward.
Investigations and trials also require the creation of a wealth of technical documentation. As sector specialists, we can assist in translating this highly specific content in a way that is accurate, quality-managed, and tightly version-controlled.
Added to this technical documentation is the significant workload associated with gathering and translating the right data for approvals. We use translation memory, AI-assisted workflows, and custom automation tools to streamline the translation process and adapt outputs to suit different end uses — whether for internal reference, investigator use, or submission.
Why Work With Us.
Trusted by organizations all over the world
Case Studies.
FAQs.
Translation costs and timelines vary depending on factors like language combinations, service levels and volumes. We assess each new project and provide a corresponding quote detailing costs and turnaround times.
Please get in touch with the team and we will be very happy to produce a quote or estimate for you.
Yes, over the years, we have created many AI tools to automate time-consuming processes and tackle recurring challenges. We may also implement AI translation where appropriate, depending on languages and content types. We will advise on our recommended approach on a project-by-project basis.
At Conversis, our QMS runs through every level and function of the business. Part of our continuous quality management process is maintaining our ISO certifications – ISO 9001 for quality, ISO 27001 for information security, and ISO 17100 specifically for translation.
If you would like to know more about our QMS and quality accreditations, please get in touch and we will be happy to provide more information.