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Today, an up-to-date data management system is a must for any modern hospital or biotech company. The vast amounts of data and paperwork produced in traditional medical treatment, research, and development institutions, not to mention the vital importance that this information makes it to the right place, pose serious management challenges for employees. Modern software systems, however, offer sophisticated tools for efficiently managing hospitals and biotech, making processes as straightforward and streamlined as possible for their employees. Many of these solutions have also expanded beyond simple billing and general hospital management and have become vital to medical research, offering an array of sophisticated tools for storing vast amounts of data in single, quickly searchable databases, allowing ad-hoc statistical reporting(1).With the ability to support any sector or level of hospital or biotech management and expand and improve quality control and research potential, the question hospitals and biotech companies now face is not “do I need a hospital/research/biobank/trials management system?” but rather, “where should I get one?”
What may start out seeming like a simple question raises a lot of new ones. Hospitals with a focus on clinical research and larger biotech companies seeking new software solutions typically consider two main choices: 1) task the local IT department with building a customized solution for their research team or 2) look outside for a suitable software solution developed by professionals in medical research IT. Naturally, both options carry their own set of pros and cons that depend on a series of factors. These important considerations include costs (short-term and long-term), time until execution, long-term sustainability, quality of tech support, synergy with hospital/company needs and SOPs, and implementation of up-to-date tech developments and software tools. The relative importance of these factors depends on the resources of the specific hospital or biotech company looking for a new solution and their particular software needs. Keeping these in mind is important when exploring the specific costs and benefits of building software in-house versus purchasing a professional software solution developed by experts.
Home-Grown Software Solutions
Hospitals and large biotech companies that task their own IT departments to build their software system can develop a highly customized solution that supports existing processes. It is important to note the value of an in-house development team with a nuanced understanding of the local institution, internal processes, and needed specification as well as the motivation to develop the ideal solution for the hospital or company they work for (2). The resulting software is typically designed to support the existing status quo of processes and procedures within the hospital or biotech company. This means that doctors, nurses, and researchers can continue to do their work exactly as they have been doing it, but with support of software tools, rather than learn new processes and adapt their work to a foreign software system (3). Making use of a customized solution can save time for healthcare professionals and researchers, allowing them to continue their valuable work while shortening the adjustment period and therefore reducing room for error in their work.
However, the level of software customization and the availability of local tech support come at significant costs. Large hospitals and biotech companies building their own software systems must employ a substantial technology department, which becomes quite expensive. In most cases, an existing IT team is too small to effectively develop, maintain, and continuously update a new software system (3). Additionally, the quantity and frequency of requests and priority demands from employees using the software create a task overflow for the IT team drawing their resources away from the work they are already doing (4). This means that many large hospitals and biotech companies must begin vetting an experienced team of professionals to expand their IT department before building their software solution, a process that alone can take months and which results in further financial costs in the form of salaries and the essential hardware and office supplies for the new employees (2).
In addition to the time and money spent expanding the existing IT department, there follows the period of developing the software itself until it is finally executable, which can take many months or even years. The total time until implementation, starting when a hospital or biotech company decides to build its own software solution and ending when itis fully functional, can be quite significant and is difficult to approximate because it varies so widely case by case. Then, even after the new software solution is built, the expanded IT team must keep it up-to-date, incurring significantly more long-term costs than if a hospital or biotech company were to purchase a professional software solution from an external vendor (4).
Professional Software Solutions
Another option for biotech companies and hospitals is to purchase an expert software solution designed by professionals. These tried and tested software systems are generally more reliable than those built in-house and include up-to-date features and functionalities that incorporate the latest technological developments and support best practices in medical research (3). Hospitals and biotech companies that purchase these software systems often find much more advanced and professional solutions and tools that adhere to the highest regulations and that have undergone thorough verification.
In addition to the level of expertise found in the solution itself, using a proven software system also means that hospitals and biotech companies do not need to wait long before its implementation (3). This allows hospitals and biotech companies to continue focusing their resources on their core work. Another benefit of purchasing a professional software system is that outside vendors offer constant tech support to hospitals and biotech companies, eliminating downtime caused by, for example, technical issues arising while in-house employees are off on holiday. Moreover, most IT providers offer comprehensive support for their products, which includes a full-time emergency contact who is available even at night and on weekends (4). This ‘round-the-clock tech support offered by most software providers, together with the relatively swift implementation of software itself, and its set of tested tools make purchasing an expert software system a more reliable and easily implementable solution.
Of course, a proven and quick-to-implement software system comes with its own costs. Firstly, the initial purchase of such a software can potentially be more expensive than building a solution in-house, depending on the scope of the solution (however, this path leads to many more accumulated costs in the long run, as discussed above) (2). Purchasing a professional software system is generally more relevant for hospitals and biotech companies with large budgets available and is less of a viable solution for those unable to make this kind of investment.
Another consideration for biotech companies and hospitals is where to purchase this software. The global market is full of software solutions specialized in different fields of medical research, each with their own unique collection of features, functionalities, and service packages. The organization culture of a software provider is also an important aspect to consider, as its team will ideally be working closely with its software clients for years to come (4). Because a purchased IT solution is not designed with any particular hospital or biotech company in mind and since IT affects so many aspects of their work, a significant amount of time and effort should be spent finding the right vendor. Data security is a further concern for hospitals and biotech companies using third-party software systems, as this creates more of a liability, especially regarding private patient data and product-related information. With the arrival of new GDPR regulations, it is important for hospitals and biotech companies to question how vendors protect the sensitive data of their clients (4).
All things considered, purchasing a professional software system could be the best solution for hospitals and biotech companies with funds to match the initial cost and with the time to find a fitting vendor that upholds high standards of data security. Still, very few off-the-shelf software systems offer the flexibility and customizability to rival solutions built in-house. However, such solutions do exist.
The CentraXX Solution
Combining elements of a customized solution and the benefits of a time-tested software built by experts, the CentraXX solution by Kairos brings together the best of both worlds. Over 10 years of experience in the field of medical research IT, Kairos has developed a flexible software solution that offers a wide array of proven tools and modules in a highly customizable package.
With the benefit of a professionally developed solution, CentraXX offers a variety of expert features including advanced data protection and de-identification mechanisms, interfacing to EMR’s and other third-party systems, GCP adherence, an integrated workflow engine, and a Meta Data Repository to harmonize datasets. The addition of the CentraXX Patient App helps hospitals and biotech companies comply with GDPR regulations, allowing patients transparent access to their structured data and bringing informed consent management to a new level.
The highly developed and specialized features that CentraXX offers are prime examples of the benefits of professional software solutions. However, unlike most professional off-the-shelf solutions, CentraXX’s broad array of expert functionalities are highly flexible, leaving much room for adjustment and customization to the specific needs and SOPs of hospitals and biotech companies.The analytics component of CentraXX for examplesupports the customized creation of reporting templates to query and compute all data in CentraXX. Perhaps most important for system customization is the fully integrated workflow engine. Using this tool, local CentraXX administrators can design documentation tasks in customizable system dialogs, spread across multiple user groups, thus orchestrating complex processes according to specific SOPs, making entire research projects more transparent and cost-efficient.
By PD Dr. rer. nat. Christian Stephan/Amir Sohn Firestone, Kairos GmbH