Clinical trials are the sine qua non of modern medical research,
providing the testing ground for new therapies and treatments to gain
and maintain the trust of regulatory authorities, patients, and
physicians. However, the path from hypothesis to clinical application
is beset with obstacles that hamper speed to market, inordinately
increase costs, and make it difficult to comply with regulations.
Leading the challenge is the volume and variety of data created during
a trial's design, data collection, and analysis. Data is often
generated and moved via paper forms or input into multiple sources and
trackers. All this data processing means inefficiencies and the
potential for error. And because our trials are highly regulated,
we’re obeying every protocol every step of the way – creating dozens
of different flows, regulations, and outcomes that must be tracked.
Licensing off-the-shelf software comes with its own obstacles, which
is why custom software for clinical trials has recently been gaining
traction as a technology revolution. These tailor-made applications
use technology to rework every aspect of the process, from
streamlining data collection and analysis to improving recruitment and
retention, with the objective of complete process optimization.
Custom software development for healthcare
is poised to play a more significant role in shaping the conduct and
success of clinical trials. Improved workflows, reduced errors, and
the maximum possible use of data for clinical research are just some
of the potential benefits we may soon see by utilizing custom software
development healthcare. In turn, this could help to bring drug and
therapy treatments to market faster and safer. In this blog, we aim to
examine the future of medical research and its implications for global
health by exploring the ways that custom software development could
soon transform the way clinical trials are run.
In clinical trials, efficiency is vital – more than just a nice thing to have, efficiency is of paramount importance, as it can dramatically impact study outcomes in terms of cost-effectiveness. From the beginning of their conception to the final determination of either a novel medicine’s approval and market release or its rejection, all the steps involved in a clinical trial have a direct impact on the time it takes to bring forward a potential new medicine for those who urgently need it, as well as on the quality of the data produced and the precious individuals and organizations that generate it. This section will list why efficiency is of the essence in clinical trials, reviewing the importance of efficiency in innovation and clinical trials, intending to improve patients’ lives.
While this notion is not a guarantee of predictability or replicability, it is certainly a cornerstone of efficiency, and it has significant implications when it comes to achieving study endpoints such as capture of the patient population, cost-effectiveness and completion of the scheduled programme. Once this is partially understood, appreciating the transformative properties of efficiency will help to develop a clinical research sensibility.
Inefficiencies in conducting clinical trials carry a high financial cost. Delays, redundancies, and wasted resources all add up. Industry estimates suggest that, depending on the size and complexity of the study, each day of delay can cost anywhere from tens of thousands of dollars to millions per day. Direct research costs are only part of the equation. There are also opportunity costs associated with the delay in market entries and the subsequent revenue lost by the pharmaceutical companies and health practitioners involved.
Time is just as essential in clinical trials. Unnecessary delays in trials mean that patients are denied access to innovation for longer: the longer a trial, the longer the search for a new treatment gets held up, and the longer a new therapy is kept from a patient who needs it. Lengthy trials prevent the ongoing flow of scientific insights, too: fewer data means fewer answers and a slower pace of progress, which in turn has implications for future studies. In terms of patient access, speeding up trials ensures that patients get new treatments sooner and saves money for the overall system by reducing waste.
Data generated by clinical trials must be robust and reliable to make meaningful inferences about the effectiveness of the intervention, as well as to avoid patient harm. Inefficient data management that consists of manual data entry into Excel across many unconnected data sources is open to errors and systematic issues, which is of no use, compromises the integrity, and leads to challenges with the study results for regulatory review (for approvals) and in ensuring the safety of the data for patients. Reducing the time taken to both collect and analyze data requires streamlined data flows from real-world sources into the trial in the most efficient manner possible.
The reality of conducting a clinical trial is that there are so many complex challenges, from head office to side office, to patients, to regulatory bodies, to sponsors, that getting through them all, let alone the trials themselves, is a challenge – and I think one that is worth overcoming. It’s all about finding the right way forward. That way forward, if we manage it right, it improves not only the efficiency of trials but also the outcomes for patients, doctors, sponsors, and others.
The data that is generated, especially given the typically large number of subjects, is immense and diverse. It is logistically difficult to manage trial data efficiently using paper-based or disparate electronic records that have multiple points of data entry, therefore creating inefficiencies, data silos, and ever-increasing administrative burdens. Custom software used to support centralized data management can provide a harmonized way of capturing, reviewing, integrating, and analyzing real-time, critical data from the trial to increase the efficiency and consistency of data across trial sites and stakeholders.
Strict regulatory requirements are necessary for patient safety and data integrity, but challenges posed by regulatory burdens also lead to inefficiencies in trials. Compliance with various international standards and evolving regulatory requirements, such as the increased adoption of linked data, requires significant up-front planning, documentation and adherence during the entire lifecycle of a clinical trial. A custom software package with compliance tracking features can simplify regulatory requirements, automate documentation processes and include checks for registry compliance, mitigating administrative overhead for researchers and reducing the risk of compliance mistakes. Instead of spending valuable time on administrative tasks, scientists can focus on scientific pursuits.
Enrolling participants in clinical trials on time and in sufficient numbers is critical to keep the trial on schedule and optimize its statistical power and impact. Many trials are delayed because of recruitment challenges, including geographically dispersed trial sites, stringent eligibility criteria, patient reluctance to participate in clinical trials, and other factors. Patient recruitment analytics, outreach and engagement can provide powerful solutions to help address these recruitment challenges proactively, improve patient recruitment processes, enhance participant engagement, and improve the timeliness and cost-effectiveness of clinical trials. With the use of patient recruitment technology, researchers can find eligible patients more efficiently and engage with them more effectively, improving the enrolment and retention of trial participants and accelerating the timelines of trials while decreasing trial costs.
Innovative custom software solutions have enabled clinical trials to become a more efficient, and less painful process for patients. This section discusses the major features of such solutions and how they are used to improve every step of the clinical testing journey.
A key capability for transforming data management practices is the use of custom software solutions to replace paper or multiple disparate electronic systems. Custom database applications built through healthcare mobile app development help clinical trials become more streamlined by securely collecting and storing data centrally in real-time throughout the trial, regardless of the location of a trial site. For instance, advanced analytics capabilities in the software can help with the meaningful use of data and to maximize data quality so that robust analysis is always possible.
The ability of clinical trials to recruit and retain suitable participants is fundamental to the success of the trial, and custom software development for healthcare provides solutions that can greatly improve this area through a variety of methods. Patient recruitment modules can use algorithms and harness data-driven analysis to optimize trial recruitment. Features to personally message and interact with potential participants, along with patient engagement modules, can gather data and communicate ongoing support to trial participants to keep them involved – ultimately improving the trial's recruitment and retention rates. By improving efficiency through the use of software to manage these processes, recruitment times are greatly reduced while maintaining optimal sample sizes that are able to produce statistically meaningful results.
Customised IT-solutions enable compliance at every step of their trials through automation of regulatory document management, tracking and submission processes, while eliminating administrative demands and mitigating process-susceptible mistakes. In-built checklists for compliance, and audit trails for accountability, speed up interactions with regulators, and optimise chances of regulatory approvals.
Through custom software solutions, administrative workflows can be automated: for example, by scheduling, monitoring, and reporting the study’s daily activities, by setting up automatic alerts and reminders about upcoming deadlines or milestones, etc. This would save human resources currently dedicated to checking lists, issuing reminders, preparing reports, and doing many of the other typical administrative tasks. These precious resources can, in turn, be redeployed to scientific research or directly to patients. This fosters a healthier research environment, improves productivity, and boosts the likelihood of making a difference for patients.
Custom healthcare software product development offers real-time monitoring capabilities that enable continuous trial progress and patient safety assessment. Real-time monitoring helps assess trial progress and patient safety at every trial stage through integrated dashboards, which deliver instantaneous access to comprehensive, data-driven insights. Occurrences predict adverse events and make timely decisions with a deeper understanding of participants’ adherence to the trial; researchers can quickly detect adverse events, make timely decisions about protocol changes and early termination, and make necessary design adjustments. Advanced analytics support predictive modeling and trend analysis to enable researchers to make more informed design decisions and allocate resources to respond to changing data trends and achieve promising research outcomes. Overall, through real-time data analytics, decision-making becomes more accurate and safer and has a faster turn innovative therapies for patients needing them.
Selecting the right custom software provider is crucial for the success of clinical trials, ensuring seamless integration of technology to streamline processes and enhance efficiency. Here are key factors to consider when choosing a provider:
Choosing a provider with a proven track record in healthcare custom software development is essential. In healthcare in particular, specialized knowledge and experience in this complex environment can be crucial. In addition to the high safety standards required for pharmaceutical and healthcare solutions in general, specific regulatory frameworks in this industry mean that customers who have successfully delivered in the healthcare field are likely to be uniquely qualified to develop an effective and efficient solution. For example, your provider may have developed electronic health records (EHR), software that meets Health Insurance Portability and Accountability Act (HIPAA) compliance, or a clinical trial management system (CTMS) software that allows trial sponsors to manage the entire clinical trial process. Such expertise in the healthcare field typically translates into better solutions that are easier and safer to integrate into your organization and can help to ensure that the trial you run is conducted in full compliance with all regulatory requirements, helping to make healthcare research effective and safe.
A client-centric approach is paramount to understanding the needs and difficulties when it comes to dealing with the stakeholders, streamlining the clinical trial process from beginning to end, and reducing defections. A reliable software provider offers custom healthcare software development services that bring proactive orientation, active participation, and effective engagement as the provider takes the time to understand a client’s requirements and assess their needs by discussing and working closely with the team through the development process. The software is developed and equipped with all the technical details and specifications that would prominently cater to the various needs of research organizations or sponsors, as well as the healthcare providers’ workflows and operational preferences for delivering their most essential research. This becomes possible when the provider and key stakeholders maintain open and productive communication and a collaborative partnership from the beginning to search for the application.
The higher the track record of the software provider in delivering quality services, the better their chances of successfully implementing the solution; it is a key marker of success. Companies need to check the track record of the software provider vis-à-vis live implementations, as well as testimonials, references, and case studies related to the experience of providing services in the healthcare and clinical trial domain.
Often, a failure to plan and execute post-deployment support and maintenance will hinder software usability. A reliable provider offering healthcare mobile app development services should ensure your investment is sustained, delivering 24/7 support services for continuous clinical trial optimization in the long run. A well-established healthcare mobile app development services provider will instill confidence with well-rounded support services like help desk, proactive and reactive monitoring, root-cause analysis, systematic fixes, robust governance, and stay-in-touch technical support. Having clear service-level agreements (SLAs) that state response times and support protocols will help you plan your future requirements around support services.
Emerging as a new wave of technology, custom software solutions are
aiding pharmaceutical companies in increasing the speed of the
clinical trial process and medical innovation. By maximizing the
variable of time, custom software will optimize the trial process and
improve each step of the trial through data processing, regulatory
compliance, patient recruitment, and administrative efficiency. First,
through more properly formatted, onsite data management, real-time
monitoring, and adaptive design, custom software can balance trial
speed with accurate data capture. Second, patient communication
through optimized mobile applications and participant portal software
will enhance the trial experience for participants, improve remote
monitoring, and provide better patient insights.
Powered by AI and machine learning advances, integrating
custom healthcare software solutions
in healthcare studies would make clinical trials more inclusive,
precise, and rapid. Moreover, the technologies will empower
researchers to discover novel concepts, treatments, and therapies with
unprecedented certainty and control. Ultimately, successfully
integrating these technologies into the clinical trials industry means
radically improved treatments, health outcomes, and faster access to
those treatments. Custom software solutions can streamline other
healthcare areas, such as medical billing. Rather than cutting down
trees for paper, healthcare can capitalize on technology to deliver
digitally stored and customized bills to benefit everyone in the
healthcare ecosystem. Regardless of the future of healthcare
technologies, we can expect that researchers and doctors will continue
to harness newfound powers to understand previously unknown health
conditions and the innovative treatments needed to treat them. Moving
away from blocked or labored clinical trials towards more efficient
studies can hopefully be achieved shortly, ultimately bringing about
many positive and transformative changes for our medical research
industry.
