If you are a business development manager for a localization company, focussed on winning new life sciences clients, what level of expertise and knowledge do you think is important to possess when talking to a new prospective buyer of your services? If you are a project manager in this field, how much knowledge is enough in order to take good care of a client, to ensure they receive the deliverables they are expecting? Admittedly, working on projects or winning deals with companies in this market can be more challenging than others, as there is so much information to take into account. You need to know your stuff, but are not expected to be an expert; just have sufficient knowledge, resources and experience at your fingertips to do the job well. Building a network of good contacts who can offer specialist advice is also advantageous. Some of the challenges below could be ones you have come across in the past, or may face in the future, so I hope they will resonate with you. Rest assured you are not alone in those tricky “client-management moments”!
In-Vitro Diagnostics and the Regulations
Presently in vitro diagnostics and medical devices are subject to the following directives: Medical Device Directive (MDD), In Vitro Diagnostic Medical Devices Directive (IVDD), and Active Implantable Medical Device Directive (AIMD). May 2017 saw the publication of the new EU medical device and in vitro diagnostic medical device regulations, which will affect device manufacturers as well as any organization that is offering services and therefore forming part of the supply chain. So translation companies need to be aware and take note! They must also demonstrate a genuine interest, as it affects their clients, so it is wise to keep up with industry activities and developments. Translation clients will need to prepare and plan ahead to ensure they remain compliant and therefore may need assistance in updating texts in each of the languages they work in. As a project manager or account manager, are you being proactive in asking your clients if they will need to update texts, product packaging and labelling, IFU’s (Instructions for Use) and user guides? Aside from giving them full support, there may be opportunities for bringing in further revenue due to these changes. Being proactive can reap rewards as well as supporting your clients in a positive way.
Contract Research Organizations
Many interesting and challenging points will arise when working with a CRO (Contract Research Organization) or bidding to win a contract with one of these companies. They will often be looking to outsource translation projects on behalf of one or more of their pharmaceutical clients, and will be responsible for evaluating and selecting the most suitable resources to do the job and do it well. They will ask you many probing questions to filter out those who make the shortlist, such as:
- how you manage risk
- what percentage of your revenue comes from life sciences and of that, what comes specifically from pharma and other CRO’s
- how you ensure clinical terminology consistency and scientific accuracy
- how your quality management systems are structured
- version control of documentation
- file security
- resources’ specialization
- what your biggest challenges are at the moment and in the foreseeable future
Of vital importance to a CRO is your demonstrating knowledge and a proven track record in the language demands of documents such as QRD (Quality Review of Documents) templates for pharmaceutical companies, who must have everything approved by the European regulatory bodies. Once you are working with a CRO, you may find it challenging when faced with queries that require answers from the end client, but your contact is in between you and them. Messages can get filtered or delayed, when time is of the essence and you need to complete your work on time. In-house training programs for production staff are a must for anyone looking to work on CRO or pharmaceutical clients’ projects. There are to be no mistakes made or questions asked that could appear to give the impression that not enough knowledge is there to do the work well. Senior production managers must ensure all staff is up to date with the relevant knowledge and resources, such as that from the European Medicines Agency which offers information on clinical data, EU clinical trials register and recent news.
Pharmaceutical clients and their specialized needs
Dealing direct with pharmaceutical clients has its rewards and its challenges in equal measure. On the up side, once you are working with a client, and delivering translation work that is up to scratch and of high quality, your client is unlikely to switch vendors and risk training up a new set of resources. Pharma companies can spend big when they have a requirement, and often need their documentation in 24 languages, which multiplies the workload more than other types of medical organizations who may only work in a few. On the reverse of that, they are the most demanding of life sciences clients, and rightly so, with their huge investments into research and development, often racing to secure a patent for a product before a competitor. They need to rely 100% on their translation partner to deliver on time and to a high standard. Certainly worth the effort I would venture.
To sum up, and based on my experience selling into these markets for over ten years, I would conclude that working with clients and looking to win new business is challenging but very rewarding. Life sciences clients are, generally speaking, loyal to their translation partners, as a sharing of knowledge and product development is present and the two parties grow together with the experience. On the challenging side, trying to win business from a company who already works with another translation agency can be more than a little tricky! When you win your new clients, work hard to keep them by staying up to date with all their news and industry developments, as well as delivering the quality they expect plus a little bit more. You can’t go too far wrong.