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International Clinical Trials

About Time

The continuing globalisation of the life sciences market and mounting requirements from regulatory authorities have turned clinical trials into an ever-more multinational endeavour. One of the implications of this has been an increasing need to communicate with patients and health professionals in a variety of languages.

The growing demand for translation services as a method of communicating complex medical information to a variety of groups, from patients to physicians, has extensive financial consequences.

A recent review by a global contract research organisation (CRO) discovered that translation is the second largest external expense it has, closely following site and investigator payments. This article focuses on a less obvious aspect of translation costs: the time spent by the clinical team before, during and after the involvement of the translation service provider.

Industry Attention

Currently, very few companies within the life sciences industry have in-house translators. These services are usually outsourced to external providers from the translation industry. Indeed, the spend on outsourcing translation processes has been rising rapidly in recent years, and as clinical trials become ever-more global, these expenses are only expected to grow further.

The increasing costs have stimulated a growing awareness in the industry of the importance of properly managing translation services, with many companies making organisational changes in the way they handle and outsource translations. These processes may include decisions on preferred vendors or strategic partners, re-evaluation of translation standard operating practices (SOPs), and training for the clinical team about this aspect of their work.

Layers of Cost

As part of such an organisational review process, most companies examine their current expenses on translation services – information which is usually available and easily analysed. However, this information provides only a partial picture of a company's translation expenses.

For example, many clinical teams – especially those specialising in study start-up – report that they spend much of their day corresponding with translation providers, instead of performing other critical tasks they were trained for. The additional time spent handling translation requests and translated documents is not usually measured or taken into consideration in that evaluation.

Raising awareness of this ‘handling time’ reveals additional layers of cost beyond the basic rates provided by various translation providers. Reviewing these costs may add additional factors to the criteria for selecting vendors, promote outsourcing of additional stages of the translation work, and aid in formulating more efficient workflows.

The following are several time- and resource-consuming tasks which are a basic part of every translation process, but where the time taken to complete them can be minimised.

Making Requests

Sending translation requests may seem like a fairly simple process, forming an integral part of any translation workflow. However, when examined more thoroughly, it is often revealed to be a highly time-consuming task.

In most cases, to obtain an accurate evaluation and quote, the document itself has to be sent to the vendor. Typically, this is performed using an external file management system or specific email templates, all of which take time to prepare, upload and manage.

Once the document is delivered, if the vendor's representatives are not familiar with clinical trial documents, there will be requests for additional information regarding who would be most qualified to make the translation, and the specific quality control process required for this type of document. After finally receiving the quote, the requester often has to ask for approval via additional internal systems and/or correspondence.

The time spent per document on these activities may, on the surface, seem inconsequential. However, when multiplied by the number of documents requiring translation over the course of a year – most notably the fact that each country office or affiliate that handles its own translations is repeating the exercise – the total time suddenly becomes significant. Improving this process can free up considerable time that can be more profitably spent on clinical activities.

The time spent on this task can easily be minimised by addressing specific elements in the process. For example, choosing a vendor which specialises in life sciences and has experience handling clinical trial related documents can greatly reduce time for both explanations and correspondence, due to increased understanding of the materials and terminology.

Another option is to centralise the management of translations – having in place a central team to make the request for translations for all countries and affiliates (with the specific regulatory requirements for each), without each affiliate having to contact the vendor individually.

Verifying Translations

One of the major areas associated with handling costs is the verification of translated documents by the in-house clinical team. This is an obvious and standard requirement that is often written into SOPs – the clinical team has to conduct an additional review after the translation vendor to make sure that the translation is indeed correct and can be used in the clinical study.

Clinical trial documents are often scientifically complex, as well as legally and ethically sensitive, and as such require very careful verification. The reviewer must carefully compare the texts, making sure that all information is presented in the same way in the translation as it is in the source document. In many cases, the reviewer also has to make sure that the translation is appropriate for the intended audience – for instance, that it will be understood by local patients and is phrased in simple, communicable language. Considering the length of clinical trial documents, this task can often consume entire working days from the clinical team's time.

The time spent on this process does not end here: once the review itself is done, the comments typically have to be forwarded to the vendor for review. This can lead to a backand- forward correspondence about preferred language and terminology, taking even more time and postponing use of the translated documents.

The review process can be simplified by using various methods. The requester should make sure that the translation vendor is given any other material translated for the same study, as well as any glossaries or translation memory that have already been created for it. This will allow the translator to have a better understanding of the required language and terminology for the new translation, and reduce the number of corrections made during the review.

The person making the review, on the other hand, should be instructed to focus on important changes which influence the meaning of the translated text and not on preferential changes, thus making the review process more focused and effective.

Increasingly, CROs and pharmaceutical companies prefer to have the vendor conduct its own verification process prior to delivering the document. This additional review, if performed by an expert reviewer who has a background and experience in clinical trials, can save over 80 per cent of the internal review time. As the cost per hour of a clinical team member is significantly higher than that of a translator, outsourcing this review process is very cost-effective. A global CRO working with this model calculated that it was saving in the region of $1 million per year.

This consideration – and the successful implementation of the process – has convinced some companies to routinely use the translation vendor to perform the two stages of review, foregoing the need to review the document themselves entirely.

Naming, Certifying and Archiving

A large part of the requester's work begins after the translation itself is finalised. Such tasks usually include saving the document under a name indicated by the company's SOPs; updating the document's footer with its name, date and language; and requesting a translation certificate with the correct name and version. This process is clearly necessary in order to maintain a document management system from which documents can be easily retrieved for audits, amendments and version updates at any given time.

While the process for each individual document takes only several minutes, this effort is multiplied when it has to be performed for each document, in each version and in each language. To illustrate the point, in one country which has three local languages, a study start-up team reported spending an entire working day on this fi ling process for an informed consent form which had several alternative versions for different sites.

Expanding the cooperation and working relationship with the translation vendor can easily reduce the time spent on these tasks. This can be done either by sharing the company's translation and filing SOPs with the vendor, or by creating mutual translation SOPs with the specific vendor.

Working with such guidelines will allow the vendor to name the documents according to the company’s instructions and to handle the document’s footers themselves, thus saving much of the clinical team’s time. It is important, however, to make sure that the vendor is well-versed in clinical trials, and in understanding and complying with complex SOPs, to allow it to perform this task to the same standard as the in-house team.

Significant Savings

While it may appear that each of the tasks and areas discussed above are inconsequential and merely a nuisance to the clinical team, it is worth reminding ourselves of the increasingly global nature of clinical trials.

The biggest impact on the total cost of delivery does not necessarily come from the single ‘big ticket’ items, but more from the small items or activities that need to be performed many times over. However, precisely because they appear small and inconsequential, the total impact can easily be hidden from view.

By adopting some of the practices outlined here, CROs and pharma companies can make very significant financial savings. Furthermore, saving time for the clinical team on these activities has a double impact that should not be overlooked; using the translation vendors to take on some of the load means trial managers and administrators, contract research associates and project managers can all be more focused on other critical tasks required for study start-up, reducing the time needed to reach study initiation and patient recruitment.

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Matan Topper-Erez is Executive Director of TransCom Global Ltd. After an early career in the communications technology industry, Matan joined TransCom five years ago. He works closely with pharma companies and CROs to create service experiences which combine scientific expertise, operational efficiency and top-quality customer service, with a focus on improving multinational translation activities and procedures. Matan has a BA in Behavioural Sciences, specialising in research methods and statistics.
Matan Topper-Erez
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