3 Barriers to Writing Automation & some Solutions
At the high-impact R&D end of life sciences, investment in technology is consciously linked to commercial priorities including innovation, efficiency and speed to market. There is an appreciation of the value of automation in administering and reporting on clinical trials, for instance. Here, smart use of technology to accelerate what would otherwise be labor intensive manual processes ensures that data representation (in form of documents/reports) is robust, bears close scrutiny, and doesn’t tie up more skilled resources than is absolutely necessary.
Writing (Medical, Regulatory, Safety, Scientific, CMC) is an art of science. Here comes the conflict of automation which is seen as “inhuman”. But as requirements are multiplying every day, how can companies manage the load without increasing resources or resorting to outsourcing or offshoring ?
All Writing teams want to spend time on “science” or “innovative projects” and not seen as a ‘cost center’. With these objectives and workload increasing, a case for technology enablement and automation is strong. So, what is holding companies back from investing in writing automation?
Below are three of the most common perceived barriers to technology-enabled writing automation, and how and why they should be addressed at the earliest.
Look at most other industries, especially those that are highly regulated, and use of IT systems tends to be highly evolved. That’s because organizations have long realized the inefficiency (in cost, time and resources) of using people to manually input data into core business systems, and then physically re-enter the information into adjacent systems in other departments.
In pharma, by contrast, "EDMS" and "Word" are the only and dominant tools provided to Authors. EDMS (whether on premise or cloud) may provide some help like versions, tracking, collaboration, but doesn't address the bulk of manual heavy lifting that needs in Authoring. Same with WORD in spite of adding some plugins and other macros.
Some companies tried (and realized it didn’t helped) is Structured Content Authoring or XML editors. These are pretty good solutions from Tech point of view, but they are not intuitive to Writing world. Authors cannot relate (or may even get irritated sometimes) to terms these tools use like fragments, rules, components, variables, inheritance and so on.
In some cases, the issue is that Writing departments (whether medical or clinical or CMC) lack access to relevant technology expertise and knowledge, so they don’t have a picture of what’s available or what’s possible – including the scope for sourcing solutions and optimized business processes via cloud-based platforms and relationships with technology vendors. Meanwhile, larger companies which do have sufficient internal resources often believe that they need to build any tools themselves, something they may never get round to – especially if they haven’t tied down a proper business case & ROI
Given that some very intuitive and easy-to-integrate writing tools do exist out in the external market, with the precise purpose of assisting in improving writing efficiency, it seems surprising that sponsors do not make more use of them – especially as the time and cost savings associated with digital solutions are shown to exceed 60 per cent when compared with processes that rely on manual writing alone.
For reasons mentioned earlier, writing does not tend to attract big budgets. This means that any investment in Writing management IT needs to be tightly targeted, and seen to deliver improved results with greater efficiency. If companies choose not to invest in transforming Writing activity, they risk spending more than they need to, and consuming too much time of busy people who have other more critical tasks to be getting on with.
While large companies, may question the cost/benefit trade-off of creating new automation aids, their internal development is not the only option. Taking advantage of a pre-existing pre-tested tool that’s ready to go today and accessible on demand via a software-as-a-service delivery model, changes the economics considerably – especially if there is no associated support burden, because the vendor takes care of everything.
Companies’ inertia when it comes to trying new technology often also comes down to an aversion to change, of having to behave in different ways which may require resource retraining. Tools’ intuitive ease of use is paramount in overcoming this very real barrier.In Writing, it follows that tools need to be easy and intuitive. If users were able to author, verify all data needed at one place, cross-check source data, content impact, simple work-flow– this could be transformational in itself. For writing departments, this improved user engagement ought to result in more complete and more reliable documents, captured in a timely fashion and reducing the burden on authors to chase up right data or information or any lack of clarity.
Looking for discrete tools which are very easy to adopt and use, and which alleviate a substantial manual administrative burden – are a good way for companies to test the potential of writing automation and amass some experience.
Embracing greater automation is going to be essential as writing/reporting requirements continue to multiply and grow, placing an ever greater strain on resources. Automation offers a way to cope with rising demand, and to simplify demanding routine tasks, as companies expand their product mix and market coverage, while maintaining regulatory compliance.
Yet, to take full advantage of the opportunities, companies need to overcome their historical barriers to technology adoption – and there is no time like the present.
Labeling Regulations/Exceptions during Covid!
Several global regulatory and health agencies issued guidance with regards to the conduct of clinical trials during the COVID-19 pandemic. This swift action taken by the regulatory agencies was in direct response to global concerns around assuring the safety of clinical trial participants, maintaining compliance with GCP and minimizing risks to trial integrity during this unprecedented time.
ZERO Guidance or Regulations given by any agency for Labeling exceptions. That means whether your regional teams are disrupted because of Covid, teams cannot follow-up labeling changes on time or people doing WFH, or other changes, your labeling obligations remain SAME, if not increased more
Label compliance may not be high priority for your compliance teams or health authorities or some of you as there are other priorities. When dust settles, some of your Labeling gaps might pose major challenges and companies will have to incur extra costs to bring any label non-compliance to order. From studies in the past, for a business, the consequences are costly, with the average label change sitting at $350,000.
In addition, the risk of non-compliance is significant. From the potential regulatory fines and loss of brand reputation, temporary forced shutdown of a full production line and cost of re-mediating, not having a validated system and process in place could have a potentially catastrophic impact on business.
Digitization & Automation offers traceability that not only mitigates potential risks but also drastically improving labeling efficiency.
For existing labels, with the help of inbuilt translation engine, reverse translations can be done on existing regional/country labels and compared to either CCDS, USPI or SmPC. This will help identify existing gaps / violations faster without having to execute “special” compliance projects saving cost an reducing pain for the teams (as labeling teams don’t enjoy doing these tasks anyways)
For future labels, technology will help in achieving a comprehensive view of labeling operations and touch points in relation to the rest of the organization minimizing your attempts to resolve any issues in isolation. With Label Content digitization, changes and life cycle can be managed holistically, rather than managing with out-dated process of managing labels/documents following painful processes of maintaining versions, copies, track modes etc.
With the ever changing landscape of labeling technology, there are now solutions on offer fit for every type of organization at all budget ranges giving modular options. Yet, for many who get satisfied with an EDMS, the implementation of these newer tools/technologies is still accompanied with apprehension (for some lack of time and for others control issues). These automated solutions can end the recurring insanity of labeling challenges. Digitization & Automation will help future proofing operations within the overall labeling supply chain.
UDI & EUDAMED Explained under EU MDR
Unique Device Identification (UDI) intended to assign a unique identifier to medical devices within the United States, it marks and identifies individual medical devices throughout their distribution and product life-cycle. Initially, the UDI system was created, developed, and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement.
With certain exceptions, every medical device label needs to have a UDI mark and be composed of two parts:
Therefore, UDI = DI + PI.
In 2007, the U.S. FDA developed a labeling system that would uniquely identify every single medical device (MD) on the market. The Global Harmonization Task Force (GHTF) soon recognized the global relevance of such a system and adopted respective guidance that was last released in 2013 by the International Medical Device Regulators Forum (IMDRF), international cooperation of regulators made up of industry stakeholders and GHTF successors. (Interestingly, Medical device manufacturers experienced in the U.S. market have quickly recognized the similarity of the EU regulation as compared to the U.S. Food and Drug Administration’s (FDA) UDI guidelines.
Following the global trend in handling the trace ability of medical devices, the EU Commission has clearly defined the requirements for the implementation of a Unique Device Identification (UDI) System in the final text of the new EU Medical Device Regulation (MDR) 2017/745.
The EU UDI System, like the U.S. UDI requirements, will be implemented in phases, starting with the highest risk classes first, and lowest risk classes last.
EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission's Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC, and 2000/70/EC.
Under these Directives, Member States need to ensure that medical devices that are placed on the market and put into service comply with all provisions of the Directives, including the ‘essential requirements’, and that no obstacles are encountered for the free movement of approved devices. The Directives also require that data be stored in a database in a standardized format. The EUDAMED project aims to address the effective implementation of this provision of the Directives.
Following are the common elements between GUDID and EUDAMED but they likely need to be translated into 24 official languages of the EU:
Unlike GUDID, EUDAMED is adopting a risk-based approach for UDI submissions.
*These compliance deadlines are subject to change as the fulfillment of the requirements is dependent on the progress of the EUDAMED implementation and its availability
Measures to Overcome Low Stock Supplies in Clinical Trials Using IRT
Management of clinical supplies in clinical trials has become a major hurdle in this new era of clinical research. With the complex challenges that clinical trials shoot in terms of the design or the study population or the subgroup categorization has put the supply chain managers in a critical pose.
IRT shall ease the work of the Supply Chain Managers by taking prior measures of a few main factors that hamper the management of the clinical supplies at sites. The new designs in the clinical study conduction involve the multi-centers that are in National and International locality.
A few of the main factors to be considered to take appropriate measures are:
IRT measures to overcome the Low Stock Supplies at Sites:
Any challenge related to supplies in clinical trials can be faced with proper planning, assuming the risks & challenges in advance and, also maintaining continuous communication with the study team and sponsors.
Main Factors that Unify IRT in Clinical Supplies
IRT has created its footprint in the field of clinical research and has evolved drastically in such a way that it has bought a major difference in perspective of clinical trials over the decades. It faceted itself into the streams from only randomizing the subject and assigning them to a treatment group to managing the overall supplies required throughout the study through supply management.
Multiple factors fall in line to manage the supplies throughout the study, where few of them are the number of subjects expected to be enrolled in each site, the number of days the shipments reached the site physically, etc. These factors help the system to develop algorithms that will monitor the supplies existing at site, supplies required at site within a month, and many more. These algorithms are more essential for an IRT system to function in such a way that there is no low stock of supplies at site. Few main facets that enable the IRT to function effectively are discussed below.