Global clinical research support

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  • Global clinical research support

    Background Information

    Client’s Industry

    Pharmaceuticals/Global Clinical Trials

    Type of Product

    Translation of medical reports for ongoing trials

    Type of Project

    Translation, Editing, Proofreading, Structural Review, Formatting

    Languages involved

    25 languages, including those spoken in more than one country

    Volume of work

    Currently working on two trials (different sponsors); between 4 and 20 medical reports per batch, multiple batches received weekly.

    Time frame

    Ongoing

    Project Overview

    Paragon was referred to a leading CRO to provide clinical trial translations for a late phase study of a drug being developed by one of the largest pharmaceutical companies in the world. Study participants are located around the world and the client regularly receives a large number of medical reports from the various study sites.

    The Problem

    A major CRO was unhappy with the quality and late delivery of translations of medical reports for a global clinical trial sponsored by a large pharmaceutical company. They were also concerned about poor communication with the vendor’s staff which made it difficult to address their concerns and anticipate delivery of translated reports. They asked the sponsor if they could recommend another vendor who could provide higher quality translations, on schedule and with greater consistency as well as ensure an open line of communication. They were quick to recommend Paragon, a long-term tier-one supplier and their only small business language vendor. Each batch of translations includes medical reports from multiple study sites – including those that are handwritten (partially or in full) or included more than one language.

    Languages included in their global clinical trial translations in are:

    • Afrikaans
    • Bulgarian
    • Catalan
    • Chinese (China, Taiwan)
    • Czech
    • Danish
    • Dutch (Belgium, Netherlands)
    • French (Belgium, Canada, France,)
    • German (Germany)
    • Hebrew
    • Hungarian
    • Italian
    • Japanese
    • Korean
    • Norwegian
    • Polish
    • Portuguese (Brazil, Portugal)
    • Romanian
    • Russian
    • Slovak
    • Spanish (Argentina, Chile, Colombia, Peru, Spain)
    • Swedish
    • Thai
    • Turkish
    • Ukrainian

    The Solution

    First we established an open line of communication between the CRO and Paragon’s project managers. Once they were confident that our project managers were available when needed, we began to address the issues that arose with their previous vendor. We eliminated an element of surprise by extending the sponsor’s preferred rates to their trials. This ensured that costs could be more easily anticipated and controlled. We then created and implemented a new tracking system to allow anyone to see where a particular document is at any stage of the translation process, which was a huge improvement over the previous system. The tracking system worked in conjunction with a new batching system which was developed to enable standardized turnarounds. Both of these together allowed us to address some of the biggest problems that their previous vendor had created – poor communication and reliable turnaround. It also allowed them to see that the files were going through multiple steps (translation, editing, proofreading, structural review) as stated in our bids.

    Our quality assurance processes have never been questioned by the CRO – a testament that we are delivering them a quality product, delivered on time, and backed by our vigorous internal standards. All clinical trial translations go through a structural review before independent editing and final proofreading to ensure that vital information such as numbers are properly transferred from the original to the final translation. In addition, every report is formatted to reflect that of the original.

    After 6 months of working within our new system we were rewarded with another trial, sponsored by a different pharmaceutical company. Our contract is currently being renewed and we are awaiting the start of additional trials from new sponsors.

    Want more information? Contact us today!

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