CONTRACT RESEARCH ORGANIZATIONS (CROs)

Clinical Trial Translations

Contract Research Organizations (CROs) are pressured by tight timelines, budgets, and resource constraints. Clinical trial sponsors demand that CROs employ quality and compliant processes while maintaining accurate and timely documentation throughout the clinical trial lifecycle.

Global clinical trials are increasingly complex and require documentation that is maintained according to Good Clinical Practices (GCPs) as well as regional health authority (EMA, FDA, MHRA, etc.) guidance and regulations. Because of the global nature of clinical trials, accurate and efficient translation of trial documentation into local languages is essential. The translations typically require a short turn-around, and a high degree of quality and accuracy — these mandate a unique skill set that includes an understanding of the documents associated with clinical trials.

Risk Mitigation

Most competitive CROs outsource this process to external partners who specialize in localization to minimize risk and ensure effective communications with their global audiences. These audiences include a wide range of individuals and groups, including patients and healthy volunteers, patient advocacy groups, investigators and site personnel, IRB and Ethics Committees, Safety Monitoring Boards and regional health authorities.

Each of these stakeholders has different communication requirements, which make linguistic accuracy and cultural adaptation vital for key content associated with the clinical trial. The risk of a misunderstood or inaccurate translation carries significant consequences and could potentially result in a patient receiving the wrong medicine or treatment, a serious adverse event or even death.

Creating Value

Your business is conducting clinical trials. You create value for your clinical trial sponsors by effectively applying your therapeutic area expertise and practical trial experience to the entire clinical trial lifecycle. We do the same. We create value by helping you differentiate your services with expert translation solutions that span the same lifecycle.

Our integrated solutions combine expert language services with cutting-edge language and content management technology platforms that are fueled by sophisticated machine learning.

Your success is our goal.

A Trusted Partner

We’re the global leader in content creation, translation, and delivery. We support end-to-end linguistic solutions in the full lifecycle of clinical development, from discovery and product development (Pre-Clinical & Phases I to III), to regulatory submission (EMA/FDA compliance) and commercialization (Phase IV/Sales and Marketing).

Our knowledgeable team has pharmaceutical, biotechnology, and medical device experience. We also work with some of the largest CROs in the market. We are familiar with the content, structure, use and target audiences for clinical trial documents. We apply our linguistic expertise to these critical documents to ensure efficient and accurate translations – so you can focus on conducting the trial and communicating with stakeholders more efficiently.

Scalable Capacity with Deep Expertise

25 years of localization experience for clinical trial documentation

Access to expert resources in 59 offices around the world

A robust team of 1,200 in-house translators

More than 15,000 tested and qualified freelance translators

ISO 17100:2015 certification

Market-leading translation technologies

The SDL MultiTrans Translation Management Platform

SDL MultiTrans enables CRO teams to centralize, automate and manage clinical documentation processes in a highly secure environment. SDL MultiTrans leverages your translation memory and unifies your terminology for accuracy and high-quality translations while increasing efficiency.

With SDL MultiTrans, you can connect your eTMF to your linguistic stakeholders in a highly secure environment. SDL MultiTrans allows connectivity of your content, to machine and human translation resources, with a unique ability for online review of content.

Whether your team needs top-tier translation services, access to a robust translation management platform, or a combination of the two, we offer unparalleled capabilities for quality translation at scale.

Our experience managing and translating clinical trial documents includes (but is not limited to):

Study Planning Documentation

  • Patient Recruitment Documents
  • Study Protocols and Amendments
  • Investigator Brochure

Patient Materials

  • Informed Consent Forms
  • Case Report Forms (CRFs)
  • Patient Diaries
  • Instructions for Use (IFUs)

Safety Documents

  • Adverse Event Source Documents
  • Development Safety Update Reports (DSURs)
  • Suspected Unexpected Serious Adverse Reactions (SUSARs)

OUR PROMISE

Our language expertise and technologies will help you deliver more value to your global consumers.