Life Sciences
You need:
- Clinical, regulatory, or related legal, manufacturing or marketing language services
- Very high-quality translations from a well-organized, professionally managed provider
- A partner with experience serving pharmaceutical, medical device, and Independent Review Board clients with language services
Solution: McElroy’s life sciences translation services
Life sciences, particularly pharmaceutical translation, make up a very well-established business unit at McElroy Translation. We have maintained relationships with several clients for over two decades through continually earning our clients’ business. McElroy uses stringent quality assurance protocols and has been tracking quality metrics for many years.
We are active within and well supported by the Drug Information Association and the Regulatory Affairs Professionals Society. Clinical and regulatory client work has been a cornerstone of our translation portfolio for much of our four-decade history. Our service experience to this community covers every aspect of global medical and pharmaceutical business needs, including protocol translation and informed consent translation, as well as translation of all other types of clinical trial documentation.
McElroy has experience in all steps of our clients’ journeys. Examples of some documents we’ve handled for clients to submit to their IRB ethics committee include:
- Clinical Trial Protocols
- Patient Information Sheets, Patient Files, and Patient Questionnaires
- Informed Consent Form (ICFs)
- Case Report Forms (CRFs)
- Curriculum Vitae documentation for trial investigators
- Correspondence and contracts between IRBs and investigators and their institutions
Once a clinical trial is underway, McElroy may also translate lab reports or Serious Adverse Event (SAE) reports. After the trial, we may be asked to translate a Clinical Trial Report. Then prior to manufacturing, we will produce translated (sometimes bilingual or multilingual) manuals, product labels, packaging, and inserts. We normally work in the source files so that our output is print-ready. We are even capable of managing the process of printing for our clients.
Clinical Trial Documentation
Clinical and regulatory client work has been a cornerstone of our translation and localization work for much of McElroy Translation’s 40-year history. Our service experience to this community covers every aspect of global medical and pharmaceutical business needs, including translation of all types of clinical trial documentation in all languages: Clinical Trial Protocols, Informed Consent Forms, Patient Information Sheets, Questionnaires, Scales, Lab Reports, Serious Adverse Event & Clinical Trial Reports.
Marketing Materials, Publications and Labels
McElroy offers expertise and guidance in the production of all types of marketing, labeling, and manufacturing documents. Experienced account management, project management, and a full-service, in-house production department ensure that your collateral is appropriately targeted, expertly translated, and reproduced in any DTP application in any language. These offerings, which include localization of websites and software, ensure that McElroy can provide turnkey solutions for all of your marketing and publication needs.
Case Report Forms
Translation tools and technologies are valuable in identifying and leveraging the type of repetitive text found in case reports forms, and are used at McElroy for this and other types of documentation. However, our years of experience managing projects without such tools allows us to explore a more “hands-on” approach to cost- and time-saving processing of such records where appropriate—for example, where no editable versions are available (often the cost of creating accurate, editable files can negate savings from use of tools). Our analysis of such projects takes into consideration all available methods and approaches, and is geared toward providing the most cost-effective, timely, and accurate submissions for your clients.
Do you have clinical trial documentation, manuals, product materials, or other medical or life sciences documents requiring translation?
Request a free quote or give us a call at 800-531-9977 or 1-512-472-6753 today!