Lean implementation is a transformational process and should support organizational development alongside process improvement. Non-quality in clinical trials (e.g. late site activation or inaccurate data) can be costly and disruptive.
In this Q&A with Welocalize Life Sciences Senior Director of Global Client Services Consol Casablanca, we discuss why the cost of getting things wrong is perhaps the biggest area of cost and risk improvement for many organizations.
Welocalize Life Sciences: What is the lean concept?
Consol Casablanca: Waste is anything that does not add value; it only adds time and cost. Lean methodology consists of eliminating waste from processes so that they are efficient and effective. It’s based on two concepts: Doing it right the first time and Just-in-Time (JIT). Doing it right the first time means if there is a problem, work stops until the problem is resolved. The principle that underpins JIT is that production should be ‘pulled through’ rather than ‘pushed through’. This means that production is specific to customer orders, so that the production cycle starts once a customer has started a project—no more, no less; no sooner, no later.
WLS: Why should companies implement lean methodologies?
CC: Lean methodologies allow companies to: accelerate the transformation process; become more client-oriented; develop employees through empowerment; and create an efficient system of continuous improvement. The implementation of lean methodologies is a key factor for providing better service to our life sciences clients. Through lean, we have been able to eliminate waste from our processes, thus creating robust and efficient workflows. These improved workflows enable us to provide greater quality across the entire process with faster turnaround times. We are continuously improving our processes and creating new workflows that are adapted to our clients’ needs.
WLS: What are some challenges sponsors or CROs face when conducting clinical trials?
CC: There are several challenges sponsors and CROs face during the global clinical trial process. Here are just a few:
- There is an increasing demand for clinical trials being carried out in Asian countries, however there are limited resources for some regional/local languages.
- Ethics committees/Institutional Review Boards not accepting translations of Patient Information Sheets/Institutional Review Boards because of low legibility, causing a delay in the start of the clinical trial in that country or site.
- Different documents need to be translated or can be kept in English depending on the target country.
- Patient-reported outcomes need to be perfectly understood in the same way by patients in different countries in order to be able to pool the data across countries.
WLS: How can Welocalize Life Sciences help with these challenges?
CC: With offices all over the world, Welocalize Life Sciences has easy and quick access to almost all possible target groups. Through standardized but flexible translation workflows we can guarantee quality translations even into languages where finding qualified resources seems impossible.
Thorough pre-production, expanded clinical investigation term data bases, translation memories of thousands of approved translated segments, support to translators throughout the life cycle of the projects and innovation in technology are only a few of the steps we take to guarantee high legibility in our translations.
To manage and eliminate non-quality in clinical trials, Welocalize Life Sciences implements lean methodologies. The result: Risk mitigation and improved efficiencies and quality.
WLS: Any additional input or advice?
CC: In addition to eliminating waste from our processes and creating efficient workflows, Welocalize Life Sciences works with qualified, experienced medical translators to doctors and healthcare professionals that provide advice and support in all regulatory and legal matters. Moreover, our production team is highly experienced and up to date with all new regulations and industry trends. Implementing lean methodologies, working with subject matter experts and client-focused processes are all key factors for providing better service to our life sciences clients.
Consol will present at the Life Sciences Business Round Table at LocWorld Barcelona, June 14, 2017. Attendees will benefit from this session in multiple ways. She will show how to identify non-quality costs in order to reduce them by implementing corrective measures. Find out more or register at LocWorld.com.