As the pharmaceutical industry squares off against the challenge of globalisation, there is a greater need for content than ever. Driven by forces from both the clinical and commercial sides, pharmaceutical companies are experiencing rising costs and competition. Ultimately, to enable businesses to compete on a global scale, technology needs to keep pace with the volume and types of content needed.
Driving Forces for Globalisation. As the pharmaceutical industry squares off against the challenge of globalisation, there is a greater need for content than ever. Driven by forces from both the clinical and commercial sides, pharmaceutical companies are experiencing rising costs and competition—when conducting clinical trials and commercialising existing medicines into new markets.
This has led to an increased need to move fast in global markets to keep up with competitors. As a, result, pharmaceutical companies are faced with an enormous, language-dependent content management challenge. The increasing regulatory complexities for launching products and conducting clinical trials on a global scale has become a burden to life sciences organisations. There are diverse sets of regulatory challenges and cultural nuances that come along with each new geography that need to be taken into consideration when conducting a clinical trial.
As pharmaceutical global content needs expand, labelling and packaging is one area to pay close attention to, as indications must incorporate the appropriate language. Education is another area—both for patient recruitment and for clinical investigators —ensuring regulatory compliance across various markets. Asia in particular is a growing sector where it is increasingly important for pharma companies to be armed with the right content to educate patients and physicians, keeping in mind the local and cultural nuances. As pharma’s global content demand rises, the process of creating and localising this information must be managed efficiently and cost effectively.
The growing need for global content is much more complex than it may sound: content needs to be compliant with all local regulatory agencies, which differ from country to country. As a result, content must be laid out in a structured format and comply with specific requirements and timelines. Managing this full process—translation from a single source that is done accurately and complies with regulatory standards and then managing and maintaining updates and changes in multiple languages—is no small endeavour.
However, making sure clinical trials meet timelines and budgets is business critical. Language can be a barrier in conducting a clinical trial. Supporting documentation not only has to be accurately translated to support global trials but also accurately reflect the content and nuances of the local in which the trial is conducted. This can impact investigator and clinical staff training, site monitors and patient recruitment.
There is no room for error, as inaccuracies and delays can impact the medication a patient takes. Or, if a physician is not trained in the right language, recruitment timelines will expand. When a form is inaccurate, the patient will need to resign. Kits sent out for randomised studies must be labeled correctly too. When a trial spans several patients, years and countries, there is a significant amount of complexity involved. As trials change with protocol amendments—perhaps altering the parameters or dosage – this requires new labeling. Considering that it costs US$2.56 billon to bring a drug to market, according to Tufts Center for the Study of Drug Development, each day a clinical trial is delayed has the potential to cost millions in revenue.
From clinical development to commercialisation, all content must meet regulatory standards. Today, a launch can happen across global markets simultaneously, instead of rolling out in each market individually. Due in part to this increase in speed and reach, the world prescription drug market is expected to grow to over US$810 billion in 2017, up from US$780 billion in 2016.
Simultaneous market introduction into multiple countries adds enormous complexity and pressure for local affiliates to ensure localisation and accurate document control and translations. There is a short window where an enormous amount of content needs to be produced in a language and formatted to meet local regulatory agency guidelines, all while adhering to strict timelines.
Life sciences companies will continue to look to emerging market regions for new sources of revenue. Localising for new markets demands rigour and brings with it the added risks of legal and regulatory penalties if done poorly. Today, however, website localisation, mobile localisation and the support for local language social networks are now a necessity. Health professionals and patients have come to expect life sciences organisations to support their native language. After all, we are all consumers and have become accustomed to the on-demand experiences we have with brands. In a digital age, we can often receive the information we need instantaneously, via the channel we prefer, in the language we speak. Life sciences should be no exception, but there are several barriers to meeting this demand—regulations being one of them.
Because regulations are a fact of life, developing standardised global website templates and frictionless translation workflow are essential to successful global content management. Modern technology platforms combine web content management with digital media management, targeting, testing, personalisation and localisation for high impact digital experiences. With this in mind, it is paramount that clinical products—and all related promotional materials, documents for educating sales professionals—are globalised, localised, personalised and comply with all local regulatory labeling requirements, which are often stringent and vary across countries.
With the potential negative consequences in mind that can result when localisation and translation goes wrong, it’s important that pharmaceutical companies have a sound strategy in place for global content, incorporating both technology and services. When it comes to global health, life sciences organisations can’t afford to have any language barriers. Billions of dollars have been invested in entering new markets and patients’ lives are at stake. However, these resources will not be utilised effectively without getting the basics right. To successfully break into a new market, there needs to be a way to manage structured content and streamline the process of translation.
Streamlining and optimising regulated global content delivery is the key during this process. With powerful translation memories, translation management systems and customisable workflows, organsations can ensure quality and consistency while lowering translation volumes and costs. This can be accomplished by employing technology solutions that are purpose built to supply flexibility and control at scale.
A good first step is incorporating a technology platform that automates manual processes. This way, organisations can centralise all translation efforts, streamlining and controls translation projects to deliver quality translations on time and on budget. To ensure that things do not fall off during this process, make sure you are keeping the pace with the volume of content you are producing and that there is complete visibility and control over all documents and labels. Systems that are designed to work the way you do will enable you to scale as content and language demands increase, automate manual processes and reduce the cycle time and cost of language updates.
Ultimately, to enable businesses to compete on a global scale, technology needs to keep pace with the volume and types of content needed. This enables the ability to produce, update and automate critical business processes that can create, manage, translate and publish content, providing complete visibility and control of all document and label versions. As a result, the business can scale appropriately as content and language demands increase. Technology on its own cannot solve this massive global content challenge. It can, however, power automation and work successfully when the right processes are in place to streamline operations. This combination of capabilities mixed with the right people that understand the industry and language in that specific market, make truly removing language barriers possible. It’s important to note that technology is a key piece to the puzzle, but the human element—especially in such a complex, nuanced and critical industry—is always needed. Best in class organisations today are adopting this approach, ensuring they can embrace globalisation as efficiently and effectively as possible—meeting regulatory guidelines and ultimately, bringing new products to market for patients in need worldwide.
Kaarin Gordon currently leads the global Life Sciences practice at SDL and helps leading pharma, medical device, and CROs more effectively develop, manage, translate, and publish global content. She has spent 20+ years focused on developing solutions for healthcare and life sciences and has extensive experience in the localisation industry working with both translation services and related technologies.
