Clinical Research

Study Design &
Protocol Development

The study design phase is a crucial part of the clinical research lifecycle, as it lays the foundations for the trial to come. In this phase, we support our clients as they collaborate with international stakeholders on study design, providing multilingual translation of protocols and IBs. We also help them prepare submissions for ethics and regulatory bodies around the world, so their research can proceed to trial.

Specific Ways We Can Help.

Study protocols

We translate patient-facing materials to inform protocol design and ensure diverse patient input.
We translate protocols for all relevant audiences – including sites, regulators, and ethics bodies – in compliance with local requirements.

Investigator brochures (IBs)

These technical documents need to convey complex information accurately and clearly to keep participants safe and meet regulatory specifications. This requires specialist translators who understand both the content and how information is received in their language and culture.
We also provide streamlined translation for updates, and maintain careful version control across all languages.

Ethics applications & IRB submissions

Ethics and IRB approvals are essential in order to move your research onto the trial phase in relevant territories. Local requirements may vary, and the process as a whole can be very time-consuming.
We translate all the content required for these submissions (ICFs, patient information, reports, etc.) and help you move your research forwards.

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Overcoming the Challenges of Study Design.

Study design is becoming increasingly complex, as more technologies are added, more advanced therapies are tested, and expectations of speed and efficacy grow. It can be challenging to manage this complex process while also communicating the technical concepts of your study clearly and concisely. We help our clients to do this, working with our in-country linguists to prepare and translate their study designs meaningfully across languages.

In the design and development phase, patient centricity is key. Patient input has to be embedded in the protocol from the start and this input should be diverse – to make sure the design is relevant to the area being tested, and to the real-world patient population. We ensure our clients set their trials up for success by helping them to communicate with relevant stakeholders and translate essential documentation.

Ethical considerations and regulatory compliance are integral to ensuring your trial follows Good Clinical Practice. But submissions can be detail-heavy and time-consuming, especially if you’re applying to multiple, geographically-dispersed bodies. We help our clients navigate these processes with specialist translation and regulatory expertise from our in-house team and people on the ground.

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Why Work With Us.

20+ years in the industry

Coverage of entire clinical research lifecycle

330+ language combinations

3,000+ linguists

People on the ground in 110 countries

Linguists are subject matter experts

Custom AI for life sciences needs

ISO 9001, 17100 & 27001 certified

Work with 18/20 top pharma globally

Track record in 50+ therapeutic areas

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Trusted by organizations all over the world

Case Studies.

FAQs.

What are the costs and timelines for translation?

Costs and timelines for translation can vary depending on a number of factors, including language combinations, volumes, and service levels. We produce a quote for each new project, which includes costs and turnarounds. If you would like a quote, please get in touch with the team.

How do you ensure quality?

Unlike generalist agencies, Conversis only works with life sciences specialists. All our linguists go through a rigorous qualification process before being added to our network.

We also follow a minimum one-step review process, meaning that – following translation – content is always reviewed by a second, independent linguist with the same qualifications as the translator. Where AI workflows are implemented, this is managed by sector experts and content is reviewed by our linguists.

After content is reviewed, it then goes through the Conversis QA process, where our internal team conducts further checks to ensure accuracy, consistency, and adherence to client specifications.

Do you use AI for translation?

We use custom AI for a number of workflow management and efficiency purposes. Where appropriate, this may include AI translation. We will advise on a case-by-case basis whether AI translation is a good fit, taking into account factors such as languages and content type.

I would like to work with Conversis. How do I get started?

We’re delighted to hear that! To get started, please complete our contact form. The appropriate team will be in touch to arrange an initial conversation.