Regulatory Database Crawler – Problem and our Solution
The lexoro Database Search Solution with its crawling technology is a powerful tool. Where there is a tedious standard task for searching databases for risks, incidents, or adverse events on the non-digitized side, there is an easy to use, high-quality, and fast automation solution to conquer these problems through digitization. Why not use it?!
In this article we go a bit more into detail, which problems there are, where the core of all of this lies and what the lexoro Database Search Solution is capable of when implemented into your system environment and internal workflows.
1. The Problem
The Pharmaceutical and Medical Device industries share several products, processes, but also problems and pain points. To get to the root of the question what exactly the core of all of the common pain points is, it is important to understand the overall problem of these two industries. The first fundamental issue deals with time to market for drugs and medicines. According to a study by Joel Lexchin from York University Faculty of Health that investigated the time to market for drugs in Canada, it takes a drug – on median – 11.80 years to be available for patients on the open market. This means, that there is a lot of time and money invested in the development, the clinical studies or trials, and registration processes. Consequently, a main task or challenge for the pharmaceutical industry is posed by and will be the data gathering and information acquisition to accelerate the overall time to market workflow. As defined by several experts within Bayer AG, Springer, Pharmaindustrie-online.de, or other industry-focused companies and institutions, major trends and expectations tend to the increased importance of data and information with the “relevance of the application of Big Data technology in the pharmaceutical business today [being] extremely relevant” – as stated by A. M. Izmaylov in the publication Big Data Applications in the Pharmaceutical Industry.
When looking at the – in many aspects – similar Medical Device industry, the time to market (TTM) is not that long when compared to the Pharmaceutical industry. With three to five years between first concepts to placing the device on the market, the TTM is short – especially in a medical environment. The fundamental issue relies in regulation and registration. The Medical Device Regulation (MDR) that came into force in 2017 has had substantial effects on the whole industry. Regarding this topic, BVMed-CEO Dr. Marc-Pierre Möll has said: “If we do not take political action, we will jeopardize healthcare and lose an estimated 10 percent of companies in Germany and Europe, especially small and medium-sized ones, 30 percent existing products”. According to Dr. Van Norman this statement symbolizes the dramatic developments, that the MDR has caused within the Medical Device industry.
In summary, both the Pharmaceutical and the Medical Device industry suffer from similar issues and problems. Long times to market – induced by heavy regulatory requirements – with a necessity for either more experts or faster processes to accelerate the development and registration parts until placing the product or drug on the market. This consequently leads to workflow optimization – again induced by the trend of Big Data and the faster and better acquisition of information. The journey from data to improved time to market is illustrated in Figure 1.
2. The Solution
As many of the time to market and registration challenges of the Pharmaceutical and Medical Device industries can be connected to the lack of data that can be improved by high quality and fast information acquisition, Lexoro provides the ideal solution for various problem settings.
Since just the terms data or information are too broadly diversified, Lexoro has defined four main processes – two pre-market and two post-market each – that can have a significant impact on registration and maintaining processes. Pre-market signifies the actions and tasks to secure regulatory requirements to secure the initial registration. Post-market determines processes and obligations that help and assure to keep the product or the drug on the market.
All these required processes for both industries are building on a solid fundament of relevant data and information that have to be evaluated according to relevance and have to be summarized and filled in reports and documents to be approved by the Notified Body in various countries.
The lexoro crawler takes over the monotonous searching and collecting of these data in databases with its unique crawler technology based on Robotic Process Automation (RPA).
To optimize the Clinical Evaluation, Post Market Surveillance, Benefit Assessment, and Pharmacovigilance, lexoro has automated the acquisition and extraction of regulatory relevant information from several databases. Thanks to the crawler technology the highly paid experts from both – Pharmaceutical and Medical Device – industries are relieved of this tedious standard task that has to be performed sometimes several times per week in order to achieve regulatory-fitting results. This allows for an automatic, consistent and standardized workflow to search databases for highly competent and highly paid experts within the companies.
The process sees exactly one manual step for the regulatory departments employees which is the design and creation of a viable search strategy that the lexoro crawler can work on in medical and regulatory databases. Typical criteria are unforeseen incidents, side effects of drugs or complaints for different product types or drugs with combined medicines. After the upload via document or entering the search data into the form, the crawler automatically searches for hits and incidents based on the search strategy – all in minutes and 100% error-free due to the RPA technology. After the search process has finished, the results are displayed in an easy-to-read list that can be exported or directly be checked which hits are relevant and which are not.