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The global pharmaceutical industry has marked impressive growth over the past couple of decades, with the total revenues worldwide breaking the threshold of 1 trillion US dollars for the first time in 2014 and continuing their steep progress ever since. While China is growing fast, the US and Europe are still the key players with leading pharmaceutical companies dominating the market.
Given the size but also the significance – for the human life – of the industry, maybe it does not come as a surprise to hear that there are tens of thousands of drugs that never make it to the shelf – only a couple of dozens of new drugs receive approval for market every year. However, the following figures cannot but leave us aghast:
- only 1 in 5,000 drugs complete the journey from inception to market
- this journey lasts on average 12 years, and
- costs on average £1.15 billion ($1.48 billion)
Given the length of this journey, two things are readily deduced:
- there are many stakeholders, from universities and other educational institutions and research bodies to financial organizations and national and international authorities,
- there are numerous processes, with one or more stakeholders interacting in each process.
Localization strategy model No1: Outsourcing localization to CROs
With some of the biggest pharma companies investing up to 20% or even more of their revenues in R&D, contract research organizations (CROs) have emerged to support the industry, providing contract services for the whole spectrum of processes, from clinical research strategy and clinical trial design to regulatory submission, commercialization and post-market surveillance, and aim to reduce costs and shorten time to market. Except for activities targeted to the domestic market, CROs also support the pharma companies in their quest to pursue licensing approval in different countries and thus enter new markets. One of the additional tasks they undertake as part of the latter is the translation/localization/adaptation of the relevant documentation, which can range from PILs, SPCs, CRFs, ICFs, PROMs, SUSARs to QoL scales, protocols, labeling etc.
Localization strategy model No2: Handling localization internally
There are however pharma companies which choose to run translation projects on their side, despite of whether they outsource other services to a CRO or not. And although having the budget to outsource may be considered an asset in some companies, other companies may own all or parts of the process, including content localization, and view this as a luxury.
How to choose the localization strategy that is right for your company?
There is no right or wrong option here, as the scale of the research and the set-up of the company plays a huge role in the option to be selected, and both options have two sides which weigh differently depending on the setting, and this is how the localization business and translation agencies find themselves working for both pharma companies directly and for CROs. While one might think that process-wise the differences between the two setups are from negligent to minimal, when it comes to translation, it seems that price, speed and occasionally quality levels are the aspects that are affected more when outsourced to a CRO as part of the overall package of managed services, and let’s see why.
CROs have a rich offering for the whole journey of a drug, and some even have internal localization departments or managers, still the translation task per se is outsourced to multilingual translation companies who have the relevant capacity and resources, often themselves outsourcing it to smaller specialized in Life Sciences companies or teams of linguists. It is therefore clear why this is usually pricier and lengthier, but if it saves you time and resources otherwise, and the post-translation steps in the process are handled by your CRO and are still on schedule, it is probably fine, isn’t it?
How is translation quality affected?
Quality in translation should not be a process, it should be a mindset fully integrated in the entire production model, starting from the resourcing strategy, the selection and evaluation criteria, to the project management philosophy, identifying and making available all relevant reference material, such as appropriate templates and proper terminology resources and coding conventions (eg. MedRA, WHOART, COSTART) and effectively handling the query process amongst many languages, and all the way to the final deliverables, applying automated and manual quality checks along the way. And of course, the definition of quality and hence its measurement and assessment varies depending on the purpose. When it comes to CROs, quality is indeed of paramount importance, but quality processes pertain primarily to their core services. However, this is why they outsource this to the experts, translation agencies! And this is the a-ha moment!
Checklist for pharmaceutical companies using CROs
If you are a pharmaceutical company using a CRO for part of your drug development journey, and translation is included in this offering, good for you. You have a knowledgeable partner to support you throughout this challenging process. The same goes if you are considering to on-board one. Investing in know-how and experience, assuming you have the budget, could be a step towards faster commercialization. In this case what you may want to know about your CRO regarding the translation of your documentation is:
- What is their resourcing strategy when it comes to translation?
- Who owns the project management and quality assurance part, their in-house loc dept/manager, if there is one, or their partner for translation?
- What channels of communication can they set up – if you want to be involved – between you and their partner for translation?
- Is there a long-term quality evaluation process and can you be involved in it, if you want to?
- What is their emergency response scenario? Remember here you need to agree on a common definition of ‘emergency’
Checklist for pharmaceutical companies handling localization internally
If you are a pharmaceutical company which prefers to own the localization stage – whether you are using a CRO for other services or not – then here are some thoughts you might find useful:
- Decide (up) on your translation & localization strategy; will you be using one translation partner for all languages? In this case, you might be looking at a higher budget which however will include a bundle of linguistic services, not only translation, but you will be saving time for your team. Will you be grouping your target languages to regions and selecting a partner for each set? In this case, you might be able to strike better deals, but besides adding management time to your team, you also need to have a sound pre-qualification and selection process and hold candidates to the same standards. This gets even more challenging when deciding to use single-language partners, though in this case the main differentiator and incentive would indeed be specialization and experience. For more detailed information on how you can select a vendor keeping to the localization strategy you have decided upon, you can download our white paper for Writing Effective RFPs for Translation and Localization Services.
- Make a list of all the document types you will need localized and determine the workflow, eg. translation, editing, back-translation, reconciliation, cognitive de-briefing etc. This way you know what you are asking for and you can evaluate the proposals of potential translation partners more objectively.
- If instructions or process or product is too complex, why not schedule a live webinar for training?
Although, it’s good to have your process set, there may be points you are uncertain of. In this case, it’s better to turn to your translation & localization partner for consult, as they may be able to share best practices from other set-ups and workflows they may be working on or even willing to set up a new customized process that would meet your particular needs.
While there is no right or wrong option when it comes to forming your company’s translation strategy within the pharma industry, it is important to be aware of the variations between setups. This way you can better evaluate which one best fits your given workflow, taking into account your priorities, capacities and limitations.
If you want more information, you can get in touch with us; we are always glad to help!
Glossary of acronyms:
CRO Contract Research Organization
MHRA Medicines and Healthcare products Regulatory Agency
EMA European Medicines Agency
FDA Food and Drug Administration
ICSR Individual Case Safety Report
SUSAR Suspected Unexpected Serious Adverse Reaction
CRF Case Report Form
ICF Informed Consent Form
PROMs Patient Reported Outcome Measures
QoL Quality of Life
PIL Patient Information Leaflet
SPC Summaries of Product Characteristics