Our client
Cara Therapeutics is an early commercial stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus.
They develop a novel and proprietary class of product candidates, led by Korsuva™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body’s peripheral nervous system, as well as certain immune cells.
The Challenge
Back in 2018, when Cara wanted to take their Korsuva™ Injection to a phase III global clinical trial, the idea was to rely on the clinical research organization (CRO) they partnered with to provide all translations for the patient and site facing documents. The company also needed to conduct linguistic validation of some of the patient questionnaires for the study.
Cara’s internal team had little to no experience with global trials and was seeking support on how to approach translation and manage this important aspect of the clinical trial. One of the challenges was to identify the files that needed to be translated for all eight participating countries.
"Acolad’s processes are lean and flexible, and the subject matter expertise complemented the knowledge of the CRO in each country."
Warren Wen, VP Clinical R&D at Cara Therapeutics
Why Acolad
Cara found the necessary guidance to approach the translation when contacting Acolad. The fact that that our linguists and account team can provide subject matter expertise and knowledge of the regulatory requirements for each country was an important factor in Cara’s choice for Acolad as their LSP (Language Service Provider).
We determined a preliminary budget by collecting all necessary files for each country, providing comprehensive insight for Cara on time and cost for each piece. As part of our standard process, we continously provided transparency on project status, quality and other key performance metrics that the CRO would not be able to provide first-hand and with the same level of clarity.
All these factors convinced Cara in March 2018 to partner with Acolad for the translation services of the Korsuva Injection Study. We had been involved in the process since the kick-off meeting with all stakeholders – including the CRO team, with whom we collaborated for the coordination of all required translations.
The Solution
Besides the implementation of an individual translation memory and the setup of customized terminology glossaries, Acolad developed dedicated processes for clinical trials, as well as technologies to guarantee quality, timeliness and scalability.
Acolad’s QA automation is part of our standard production process, assuring that terminology and formatting requirements are being met.
Acolad deployed a Project Management Portal, not only to ease a complete overview and guarantee full visibility of all requests for Cara, but also to collaborate with the CRO: The portal enabled the CRO to share the required documents with Acolad. Once translated, we delivered each project with the associated certificate and administrative sign-off. Handoff and delivery process were thus streamlined.
Customized clinical trial production system
What turned out to be the most helpful of our technology solution for Cara however was the customized proprietary clinical trial centric production system.
Through this system, Cara and the CRO defined study specific workflows, tracked budget and spend, measured turnaround times as well as other KPIs and managed study contacts or roles. This was also the place where they stored study requirements, instructions and all trial-specific information to be used for final compliance checks. Additionally, the system stored all study materials for easy search and retrieval of documents, providing full management of protocol titles in all languages.
Based on the individual request, each document submitted for translation was being analyzed by the system against the original scope of work – and thus identified as either in or out of scope. The latter case initiated a routine for Cara’s extra approval for out-of-scope work.
Acolad’s study production system allowed the team to manage timelines and ensure compliance to the agreed service level agreement and KPIs - compiled into regular reports.
"Our drug Korsuva (difelikefalin) just got approved by the FDA. This is a big step for Cara, and we wanted to share the good news as you and your team were part of this journey. The support, flexibility, speed, and excellent work in translating our documents over the past few years made a huge impact!"
Frédérique Menzaghi, Chief Scientific Officer, SVP Research & Development at Cara Therapeutics
Certified processes and dedicated resources
Acolad’s ISO (ISO 9001:2015 and ISO 17100) certified processes ensured best quality from the start – including robust quality and risk management processes, but also the on-boarding of a dedicated team of specialized translators with strong clinical expertise – a crucial quality factor: We onboard only the most qualified linguists, monitoring the quality of their translations on an ongoing basis.
An agile dedicated team for fluid collaboration
Our dedicated project management team also contributed extensive experience in the clinical study space, especially for Patient Reported Outcomes and linguistic validation – which were a part of the study.
We developed an agile and flexible work environment, allowing all study stakeholders to integrate easily with the collaboration environment required for clinical trials; the direct collaboration with Cara’s CRO streamlined receipt and transfer of study material, closely coordinating timing and schedule. The Acolad Account Manager also established a solid working relationship directly with Cara study managers. Thus, communication flowed easily between the three parties: Cara, the CRO and Acolad.
The Result
The first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis
The study was successfully completed in 2019, and Cara was able to submit the product for FDA approval in 2020. Korsuva™ Injection was approved by the U.S. Food and Drug Administration (FDA) on August 23, 2021, for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis.
"We foresee a continuing successful relationship."
Warren Wen, VP Clinical R&D at Cara Therapeutics
The Future
The working relationship between Cara and Acolad continues to grow to this day with additional countries being introduced into the global trial.
Cara is developing an oral formulation of difelikefalin and has initiated Phase 3 programs for the treatment of pruritus in patients with non-dialysis dependent advanced chronic kidney disease and atopic dermatitis. They have also completed the placebo-controlled phase of a Phase 2 proof-of-concept trial of oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica. A Phase 2 proof-of-concept trial in primary biliary cholangitis patients with moderate-to-severe pruritus is ongoing. In this context, Cara trusts Acolad with the linguistic validation of the difelikefalin study, covering 13 languages. And of course, they can continue to count on us – to help their innovations be a relief for patients around the world!
Learn how Acolad can help you successfully deploy global clinical trials!
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