The life sciences industry is both complex and challenging, and project management (PM) in this sector is appealing to those who wish to work in an area that demands the highest standards of efficiency, quality and linguistic expertise. Providing high quality material is of critical importance in an industry where the stakes are high and errors are particularly costly. This is the industry for project managers who thrive on the challenges of balancing high quality deliverables, complex workflows, tight timelines, even tighter budgets and customers with a multitude of expectations.
Professionals might say that these limitations are the same in any area of the translation industry and that, for instance, PM for software or marketing clients poses similar challenges. However, project managers with experience in all these sectors will disagree and highlight the budget, timelines and, above all, workflow challenges created by the fundamental need for high quality deliverables, which are not present at the same level in other industries.
Project managers have the challenging task of working with material where accuracy is crucial. They bear the ultimate responsibility for the quality of the content and must ensure that it is presented and delivered in compliance with the vast array of regulatory standards. This is in fact at the heart of the complexity of project management in life sciences. A strong understanding of how regulatory standards are applied is expected from all those involved, from initial conception through to the release of a medical product on the international market. It is essential that the client and the project manager work together cohesively, ensuring a shared understanding of what is being undertaken, as well as an awareness of the difficulties faced by each party in seeing the project through to its completion. The process involved in developing a product can be intense, especially as life sciences regulations are considerably strict. For this reason it is challenging for a language service provider (LSP) to maintain a reputation for the highest quality and timely deliverables while still offering competitive pricing. Ultimately, to be successful within this industry, LSPs must have a strong quality management structure.
In an industry of continued research, development and change, it is vital that LSPs keep up to date with life sciences regulations. Despite the utmost care being put into a deliverable, project managers will expect their work to be thoroughly reviewed by the client, and are painfully aware that anyone, despite their expertise, can make a crucial mistake.
Past experience of quality issues and resulting implications can often lead to project managers being overly vigilant in assessing if instructions have been precisely followed. Despite being aware of previous quality checks, project managers often develop a sense of paranoia that leads them to have the product output rechecked prior to delivery.
The expectations on quality deliverables are so high that the review of work by the client can sometimes be onerous. This results from the fact that the life sciences industry is one of specific regulations and terminology that apply to a range of documentation. It places significant demands on project managers who must thoroughly understand not only the expectations of the business and the requirements of the client but of the industry itself.
When negative feedback is encountered, establishing the person responsible for the error is of secondary importance to returning the reviewed work in an appropriate time period and with the expected quality. Discarding a specific resource or removing staff from future projects with a client is not unusual. While this decision can be costly with regard to time, effort and money, it is of greater value in the long term in order to maintain the client. The smallest errors can cause delays in product submissions or releases, with serious consequences to the client’s budgets and timelines, as well as creating mayhem in sales to salvage the client relationship.
Project managers have to deal with a number of situations that forces them to develop and excel in a variety of skills. One of them is the ability to keep the collaboration of freelancers who are knowledgeable enough to work on highly technical material. They have to use all their negotiation skills to maintain the relationship, particularly in an industry where it is frequently required to work with poor source material, as is the case of documentation being provided in low resolution scanned PDF files, as shown in Figure 1.
Freelancers not only have to provide the translation in a format close to that of the source but, above all, they must ensure complete accuracy with the terminology used and the numerical data where room for deviation is not allowed. An added difficulty is that project managers usually do not provide freelancers with prepared files. The automatic conversion of documents such as the above would produce mainly gibberish due to poor resolution. Hence, it is faster to translate these from scratch, which also prevents missing data errors introduced during file conversion.
Another typical demanding task is the translation of handwritten medical text. As shown in Figure 2, legibility of the handwritten source is one of the many difficulties in life sciences work. Project managers have the tough task of negotiating rates to meet markup, all while maintaining the reliability and continued involvement of high quality freelancers. They are also required to work with difficult source material where at times translation tools cannot be applied. In the case of scrawled handwriting, knowledge of the terminology is key to understanding the handwritten text. This type of task is particularly inefficient, and at times LSPs additionally are asked to provide the translation in a handwritten format written as closely as possible to the source sentence. Given the current technological landscape, this seems a Stone Age reality. Nevertheless, this is often what clients need for clinical trials.
An alternative to this is also another time consuming and costly task, which involves the scanning of thousands of pages and the training of freelancers to discern which sections require translation. The translation is then directly inserted into the PDF file using text boxes. It is easy to guess that these are tasks linguists do not enjoy, while project managers prefer not to outsource them but instead to keep them in-house to manage costs and time.
The examples mentioned previously represent some of the multitude of different deliverables required by life sciences clients. From an LSP perspective, the output is time consuming, prices are low and quality needs to be high nonetheless. However, the benefit is that the life sciences market is ever expanding and the possibilities of increased revenue are very high.
Clients need to work with LSPs who understand the industry and who are au fait with current life sciences regulations — in other words, LSPs that do not require training and are familiar with expectations in terms of quality and submission approval, as well as being aware of the costly impact of noncompliance. Clients consequently prefer LSPs that are International Organization for Standardization (ISO) certified and operate under a strong and transparent quality assurance process. Being ISO 9001 or EN15038 certified is a strong selling point for attracting business, given that life sciences companies appreciate LSPs with a regulated internal structure. The same applies to LSPs that follow the International Society for Pharmacoeconomics and Outcomes Research’s linguistic validation methodologies, which is seen as a strong endorsement for the quality of the services provided.
Clients themselves will regularly audit LSPs, where every aspect of a pro- ject will be investigated and assessed: the tracking of documentation, the implementation of corrective actions due to negative feedback, the follow-up process on reviewed material, version control of documentation, the qualification standards of project managers and resources, storage of certificates on reviewed and final products, how confidential material is handled and so on. However, life sciences clients do not easily change LSPs given the time consuming process it requires to establish a new relationship and clarify operational processes, as well as gain confidence in the new vendor.
In this environment, translation technology can often seem of lesser importance. It is a basic requirement that LSPs provide translation technology tools that assist a client in reducing costs, turnaround time and, more importantly, that it will improve the quality of the deliverable. However, current translation tools do not fully support all the review and update requirements from life sciences clients, and the use of tools such as machine translation (MT) are not widely accepted and even point blank refused. Although clients may be aware of the cost benefits MT could offer in the short term, its use would be more costly in the long term due to the level of review required. Quality is a factor that must be applied in every step of the localization process of a medical product and shortcuts are not necessarily welcomed.
Project managers from the client side have the complex job of working with many agencies, such as: the European Medicines Agency, Pharmaceutical and Medical Devices Agency (Japan), China Food and Drug Administration or the Food and Drug Administration (United States), often concurrently. Despite the increasing global alignment between these organizations, each works under its own set of procedures. Timelines, quality and budgets are three areas of concern that most significantly impact the work of project managers, and these are essentially a question of risk management. A successful product submission will require a combination of procedures in risk assessment, confrontation, intervention and management evolution. These aim to facilitate the understanding, communication and management of a project, tackling such issues as foreign currency risk, patient safety, epidemiological studies or product liability, among many others. Limitations are imposed in any area of research and development, be it in the research, technical, safety, medical, regulatory and commercial sectors, and all of these limitations relate to budgets, quality and schedule. Here project managers can be considered efficiency experts who need to make the best compromise through risk analysis and decision making.
These are exacerbated by the long project life cycles typical of the life sciences industry, with new technologies and areas of application constantly being developed in response to the evolving nature of clinical research. There is a scarcity of available capital, timelines are increasingly pressurized and there is a greater demand for outsourcing, which is divided among multiple LSPs due to the level of market expansion.
Projects must remain within budget, given the demands on available capital. Only what is within the original scope of work should be performed, and always within the requirements of quality and safety. The projects are needed on time — not necessarily earlier. Clients value reliability above all else, which is to some extent opposite to the standard LSP practice of fast turnaround times. In today’s challenging economic environment, being within budget can at times require a Herculean effort due to the ever decreasing budgets available from global manufacturers. Nevertheless, adherence to strict quality guidelines, as determined by the international bodies, must be kept.
Products in life sciences require localization across a diverse range of application areas, including diagnostic products, medical devices, pharmaceuticals, biotechnology and consumer health information. What determines whether a product requires localization can be related to epidemiology — the patterns of health and disease in a particular population — and the need to increase international market share.
When a product is approved for international release, issues will arise such as consumer safety, liability protection and regulatory compliance. Consider, for example, Europe, which has the Medical Device Directive, the In Vitro Diagnostic Directive and the European Medicines Agency, and each has its own set of regulations. Furthermore, Europe covers over 20 languages, including Braille, which has variations between countries, implying that the Braille cell needs to be standardized to accommodate international release.
Consequently, for products to be internationalized, there needs to be acute understanding of the safety regulatory requirements, of the market differences in advertising standards and of web and software functionality, for example. Stakeholders should realize that documentation needs to follow specific template designs and layout requirements, or that graphics have to follow a specific layout and text layering. It is an all-encompassing product release that inherently requires accuracy and utmost quality, driven primarily by the nature of the product.
As in any other localization project, files are assessed and prepared for localization, and leveraged against translation memories. However, life sciences content can go through a heavy workflow in which the standard translate-edit-proof cycle is not enough to guarantee regulatory compliance. Backtranslation and reconciliation steps are fundamental to ensure the expected quality. As an example, a typical workflow for a 100 word label would easily involve the steps illustrated in Figure 3.
This workflow is followed by an in-country review and it is likely that there will be a further request to implement the resultant feedback, which will in turn imply a similar though shortened workflow to be applied. As in this example, these ten steps multiplied by the 20 and more languages handled by the European Medicines Agency, followed by the in-country review, provide a snapshot of the complex world of project management in the life sciences industry.
It is easy to appreciate why this may seem like an overly onerous process, but the delivery of quality material in a timely manner is critical to maintaining a positive and continued client relationship. After all, this level of quality control is not excessive in an industry that requires such a high level of documentation tracking, and where errors can be particularly costly.
Verification testing is also required on documents and labels for print fidelity. Software and web applications need to go through the standard bug tracking or regression testing. On consumer device software, the consistency across components needs to be tested (device and software user interface, online help, user guides or marketing materials), including testing on native operating systems, all of which need to be tracked and documented.
In the midst of these complex workflows comes the need for strict confidentiality that must always be supported by nondisclosure agreements and certificates of accuracy. Freelancers often request to be paid for providing certificates and while it can be considered an entitlement, LSPs generally do not get paid by clients to provide this. Instead, it is part of an LSP customer service, and for clients it is of the utmost importance to have these certifications for regulatory compliance.
Life sciences is a vast industry difficult to capture succinctly. It is an industry where to be successful and retain client satisfaction, one can only accept the best from all those involved in the product development process. Quality in life sciences is nonnegotiable.