Complexity around the management of labeling for clinical trials is not a new phenomenon, especially when you consider the need for most research to be done on a global scale – aligning not only to local language languages, but also local regulations and processes. In recent years, however, we have seen a surge in demand for supporting organizations capable of delivering agile clinical trials for all therapies in development so that drugs and devices can get to market faster and maximize earnings before patent expiration. An agile approach requires each stage of the clinical trial supply chain to function at speed, including label and booklet production. However, the requirement for localized labels with translated content is a significant logistical hurdle and can result in a bottleneck as translations are often the lengthiest part of the entire process when accounting for the use of translation houses alongside internal reviews. Barriers to the production of clinical trial labels and booklets at speed Agile clinical trial models tend to involve accelerated decision-making, parallelization of processes and changes to trial protocols at an unprecedented frequency. Consequently, labels and booklets need to be produced almost on-demand to reflect the latest changes. This is no easy feat for several reasons. Firstly, country-specific requirements mean clinical trial labels require localization to account for the different regulatory requirements, especially those relating to languages. When running a trial across many different countries, this means accounting for multiple official languages and numerous regional dialects to ensure compliance and understanding from patients. Furthermore, target countries are subject to change at short notice due to the availability of eligible patients, meaning the supply chain for any clinical trial needs to be able to quickly adjust and accommodate new regulatory and language requirements. Secondly, sponsors are moving away from the global hub model and increasingly introducing regional hubs to speed up delivery to trial sites while improving supply chain resiliency. The use of multiple distribution sites can introduce inefficiencies and additional risk unless robust systems and processes are put in place to minimize the duplication of effort and avoid inconsistencies in translations. Finally, the management of multiple assets also poses challenges as there must be complete consistency of translated phrases used throughout a trial. In addition, after the contents have been translated and/or other country-specific requirements are fulfilled, booklet and label designs suitable for one country may not be suitable for another due to available space for content. Finding a solution To effectively address these challenges, organizations require a clinical trials labeling solution and accompanying systems based on GxP (Good x Practice) compliance. The overall goal is the establishment of an end-to-end controlled and approvals-based process – from label and booklet design, data integration to print and finally label inspection – eliminating the potential for error. A cloud-based system is the most logical choice for organizations operating regional hubs, facilitating the sharing of critical data and helping to minimize the duplication of effort. It will integrate specialist functionality including translation management tools and
On Monday 28 March 2022, PRISYM ID/Loftware hosted a webinar exploring the transformation of the clinical supply chain over the past two years. The discussion between Simon Jones, PRISYM ID’s Head of Global Product and Bob Bowdish, PRISYM ID’s Director of Clinical Trials Sales for North America, examined how the supply chain had risen to meet the many challenges facing the clinical trials sector, enabling more agile methods of working. Over the past two years, the clinical trials industry has faced several challenges. These include a push towards adaptive trials, the need to accelerate the trials process for vaccine candidates, sustain studies when patients were unable to visit sites due to the pandemic and run efficient trials for costly and often complex set-ups that biologic therapies require. Simon Jones and Bob Bowdish explored how greater collaboration and innovation throughout the supply chain has facilitated a shift toward agile production, in the process overcoming historic bottlenecks in the production of clinical trial labels and booklets that are now being challenged by the industry. During the session, the audience was invited to participate in two polls, with the results revealing how agile working processes adopted during the pandemic were now being standardized and operationalized. The poll indicated that is the way the industry is moving, as nearly 40 percent of respondents reported that they were already making use of direct-to-patient supply and a further 38 percent are planning to. Perhaps as a result of Covid, is your organization currently using direct-to-patient supply models? Yes, we are today 16.7% Yes, we are relying on our service provider to achieve this 22.2% Not yet, but we do expect we will 38.9% No, not applicable to our organization 22.2% Simon recalled how before the pandemic, attempts to promote on-demand labeling and packaging, and therefore enable direct-to-patient supply, had been met with concerns about the availability of Qualified Persons to release the products for shipping. It was noted that a majority of those currently using direct-to-patient supply were reliant on service providers, potentially due to their ability to provide round the clock access to sufficient Qualified Persons. The audience was also asked about their usage of just-in-time and on-demand supply models, revealing that almost three-quarters of respondents were already using these methodologies to some extent or were planning to do so soon. Is your organization currently using just-in-time or on-demand supply? Yes, it is our preferred model 10.5% Yes, but only for select studies 36.8% Not yet, but it is planned 26.3% Not applicable to our organization 26.3% At the end of the session, Simon and Bob answered questions from the audience, including on the ease of implementing labeling applications in a GXP environment. Want to find out more? Take a look at our report on ‘Embracing Agile Production Methodologies in Clinical Trials’, or watch the recording of this webinar to find out how clinical trial specific labeling applications are supporting service partners in bringing more agility, flexibility, and value to sponsors.
Q1). WHAT’S HAPPENED IN THE LAST COUPLE OF YEARS IN THE CLINICAL TRIAL SECTOR? Simon Jones: It’s been a challenging two years with quite a lot of change – mostly driven by the pandemic which put additional demands on the industry. As a result, the clinical trial industry pulled together in response to the need to produce vaccinations and support clinical trials that were already underway, where patient safety remained critical during periods of lockdown. However, it’s not just Covid-19 that has caused challenges over the last couple of years. Another catalyst for the change has been the significant uptake in biologics trials, in terms of volume and geographical reach. The accompanying cost to manufacture clinical trial medication and source comparators may require changes to traditional supply models. Another thing that our customers have found challenging is continuing regulatory changes. Of which the most significant has been the introduction of EU clinical trial regulations which has influenced how clinical trial supplies are being handled. Bob Bowdish: Covid showed us what is possible in terms of shorter clinical development timelines. Sponsors are choosing service providers that can help them reduce the number of parties involved in the trial process. CDMOs are responding by adding additional service lines. Q2) HOW HAS THE INDUSTRY RESPONDED TO THESE CHALLENGES? Simon Jones: It’s been tough, but the industry has performed very well thanks to a significant level of collaboration between pharma sponsors and their service provider partners, and I think the changes that we see here have also had an impact on how packaging and labeling have been performed. The drive to perform Covid vaccination trials quickly led to a step-change in terms of the need for trials to be faster and more adaptable. The last couple of years have seen a big change in the growth of adaptive clinical trials and industry initiatives like decentralized clinical trials have come into their own. Additionally, it was clear that sponsors both collaborated more and relied upon their service provider partners more than ever before. As a result, we’re now seeing a level of transformation amongst those service providers where they are looking to standardize or operationalize some specific supply chain initiatives that they may have put in, in response to the pandemic and which they now want to keep. Bob Bowdish: Covid, lockdowns and patient safety concerns put existing clinical trials at risk. Sponsors began leveraging service providers to utilize direct-to-patient supply for the first time. One large biologic sponsor literally picked up the phone and called shipping companies that could come pick up kits and take them to patient’s homes. Another rare disease sponsor had only one patient in a country and had to make arrangements to get kits to them. Also, supply chain issues such as shortages with glass vials or sourcing comparators required sponsors to reach out to service providers that they had not worked with in the past. People were quite resourceful
AstraZeneca, a global leader in pharmaceuticals, worked with Loftware to upgrade its Artwork Management solution in order to support the company’s corporate strategy, ensure business continuity, and minimize risk. As the organization’s packaging components include cartons, leaflets, foils, and labels—each of which must comply with global regulations and good practice guidelines— it was important to identify a solution that could maintain accuracy, while also reducing the amount of time needed to complete changes to packaging artwork. With more than 1,000 users involved in its Artwork Management process, AstraZeneca also wanted to adopt a process-led solution that could enable customization and accommodate easy onboarding of new sites, partners, and customers. They selected Loftware Smartflow because of its centralized and flexible approach that includes configurable workflows to support business procedures. The result was an impressive 60% reduction in artwork lead time while boosting accuracy, transparency, and efficiency. Read on for three benefits that AstraZeneca saw after implementing Smartflow: #1 Accelerating the speed of change. One of AstraZeneca’s primary goals was to improve collaboration and effectiveness across their Commercial, Operations, and IT departments. To achieve this, they needed required a solution that supported the fast on-boarding of new entities and end users. Smartflow’s secure and intuitive design empowered AstraZeneca to quickly adopt the solution and incorporate it into daily activities. #2 Driving continual improvement with Artwork Management. Custom reports in AstraZeneca’s previous system could not be modified to meet current needs, thereby limiting their visibility of current operations. As such, they were keen on Smartflow’s ‘control tower approach,’ which utilizes data to measure efficiency and quality of processes across all operation sites and departments. #3 Supporting accuracy and compliance. Accuracy and regulatory compliance are critical to the successful production of artwork packaging in the pharmaceutical industry. Smartflow supports AstraZeneca’s ability to meet global regulations with audit tracking of changes, version control, and a centralized Digital Asset Library (DAL) that stores digital content for the multiple artworks associated with each product. Results? Moving to Loftware Smartflow allowed AstraZeneca to provide a system of transparency and accountability, while simultaneously speeding up the company’s artwork change process. Read our full case study to learn more about how AstraZeneca improved its Artwork Management processes with Loftware Smartflow, and how those same benefits could translate to your organization.
For a global pharmaceuticals manufacturer, packaging is mission-critical. After all, without it, drugs don’t move. In the tightly-regulated market for prescription and over-the-counter drugs, the accuracy and ability to manage the ever-growing quantity of content that needs to fit on a label is paramount. Pharmaceutical manufacturers must comply with the increasing number of global and regional regulations, which adds levels of complexity to the process of managing labeling. Labeling errors can result in costly recalls and significant fines, as well as damage to the company’s brand and reputation. For all these reasons, plus the need to meet various supply chain deadlines and factor in brand and translation requirements, developing new packaging artwork for a new drug or treatment can be a complex process. The trouble with spreadsheets This challenge is further exacerbated by the fact that many pharmaceutical manufacturers today still use spreadsheets (notably Excel) to manage their packaging and artwork processes. Extensive use of outdated technology of this sort often results in manual, time-consuming processes prone to errors and inconsistencies, which typically hold companies back when they’re creating product label and packaging designs. Spreadsheets are relatively easy to access and most workers have a basic understanding of how to use them, but that’s where their advantages end. At its heart, Artwork Management is about managing workflows, enabling collaboration, and ensuring good content management, but you can’t store images in a spreadsheet. At most, you can put in a note as to where they should be found in a directory. This works until someone moves a piece of artwork without updating the directory, or vice versa. This happenstance is more likely than not, as 88% of enterprise spreadsheets are known to contain errata. Second, there’s no good way to store annotations or conversations. To be fair, a collaborative solution such as Google Sheets lets different users type in comments on various action items, but no one wants to read any comment, no matter how constructive, if it’s squashed into a little cell in a spreadsheet. Not to mention, it is very difficult to find a particular comment in the middle of a vast spreadsheet with multiple lines and dozens of pages. Lastly, and most importantly, there’s no good way to implement version control on a spreadsheet. There’s a lack of structure and accountability. Effectively, there are only two ways – emailing every team member a new version of the spreadsheet whenever you make a change, or collaboratively making changes in a cloud spreadsheet. Both ways are bad. One can make changes in the cloud, but it’s hard to see who made those changes, what changes were made, or when they were made. If the changes are wrong, then it’s hard to roll them back. Email is a complete non-starter – people will lose the email thread, lose the files, and work off incomplete or wrong-version documents without noticing that they’re out of date. This kind of logjam isn’t just an obstacle to efficiency. Rather, it creates the very real danger that