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THE CHALLENGE
Antigenics' project involved translation to support the clinical trial of the company’s personalized cancer vaccine. They required immediate translation of case report form (CRF) data for an upcoming interim analysis. The reports were in nine languages to be translated into English and varied in length and volume. The type of reports were as follows: Radiology Narrative, Pathology, Hospital Discharge, Surgical Summary, Medical History or Physical Examination.
The quick facts:
• The final word count of the project was 530,000 words, 120 job numbers, 193 files.
• Source files were in non-editable file formats; many were handwritten.
• Deliverables were to be editable electronic files, custom formatted for easy reading.
• The languages were Russian, French from Canada and France, Dutch, German, Hebrew, Polish, Spanish and Swedish.
• The project began Oct 30, finished Nov 26, meaning each file had only a two-day average turn for translation.
THE SOLUTION
With a project involving critical content, nine languages and moving at this pace, tight coordination of the McElroy team demanded exceptional communication. To that end, daily meetings (of the highly structured, fast-paced variety) were held to streamline workflow, address challenges and build tactics to meet daily deadlines.
We provided status updates to Antigenics twice daily followed by a table that included McElroy-assigned job numbers matched with client reference numbers showing estimated and final time of delivery for each job. All handwritten files were scanned to PDF, and translation memory built as the project progressed.
THE BENEFITS
Antigenics met a major deliverable goal of holding an interim analysis for their renal cell carcinoma study by year end. The Antigenics Senior Project Manager attached to this localization project stated, "We sincerely appreciate all your efforts and commitment to Antigenics. It was truly a team effort and the interim analysis would not have been possible without your help."
From the press release issued by Antigenics:
“The Data Monitoring Committee declared the design and conduct of the trial sound and raised no safety concerns. The trial, taking place at 132 centers worldwide and involving more than 650 patients, is believed to be the most extensive study of adjuvant therapy in patients with renal cell carcinoma to date, as well as the largest clinical trial of any patient-specific treatment tested.”