Technological innovations are disrupting industries all over – including the healthcare and medical sectors. These emerging technologies could create opportunities for growth and transformation in medical research, particularly in clinical trials.
There are plenty of benefits to the introduction of new technologies in medical research and development. However, these mechanizations are not without their challenges and limitations. Still, tech-enabled contract research organizations (CROs) are taking calculated risks to power the next generation of medical breakthroughs.
CRO: A Quick Rundown
A CRO is a contract research organization, which supports different biotech, pharmaceutical, and drug developer companies by providing services for clinical research. These companies will outsource certain services or tasks to CROs to improve the efficiency of their research and trials.
There are large CROs that can handle a series of services, while smaller, “niche” CROs usually specialize in specific services for clinical research. Their clients – also called sponsors – range from biotech startups to major pharmaceutical companies.
These services include preclinical research, biopharmaceutical development, biosimulation tests, and data management. A CRO can also handle site selection, patient recruitment, pharmacovigilance, and regulatory compliance.
Technological Breakthroughs for CROs
New technologies transform industries every day, and clinical research is no different. Here are some technological breakthroughs that have opened up opportunities for CROs to further improve and evolve their services.
#1 — Tech-enabled patient recruitment & management
One of the biggest challenges for clinical research organizations (CROs), sites, and sponsors is patient recruitment and management. Traditionally, patient recruitment relied heavily on manual processes such as flyers, newspaper ads, and referrals from physicians. However, with the emergence of new technologies, CROs can now leverage digital channels to reach a wider pool of potential study participants.
One of the key technological breakthroughs in this area is electronic data capture (EDC), which is the process of collecting clinical trial data electronically instead of using paper forms. EDC systems can streamline the data collection process and improve the accuracy and completeness of data. With EDC, CROs can remotely collect patient data, manage data from multiple sites, and ensure data integrity throughout the trial.
In addition to improving data collection and management, EDC can also be beneficial for sponsors running clinical trials. With real-time access to trial data, sponsors can make faster decisions, identify issues early on, and adjust the study protocol as needed. EDC can also reduce the time and cost of clinical trials, as well as improve patient safety by minimizing errors in data collection.
Moreover, CROs can leverage other technologies, such as social media and mobile apps, to improve patient recruitment and engagement. For instance, social media platforms can be used to target specific patient populations, while mobile apps can help patients stay engaged with the trial, track their progress, and receive reminders for appointments and medications.
Technology-enabled patient recruitment and management have opened up new opportunities for CROs to improve the efficiency and effectiveness of clinical trials. However, CROs need to be mindful of the challenges and risks associated with these technologies and implement them thoughtfully and ethically to ensure that patients are protected and that the integrity of the trial is maintained.
#2 — Decentralized and remote trials
Traditional clinical trials are highly centralized and follow antiquated conventions. However, next-generation clinical trials are disrupting these conventions and evolving alongside technologies such as telemedicine and mobile access.
This has given rise to hybrid and remote trials, which both make use of remote trial access that allows patients to participate in studies even if they are not on-site. These trials break down barriers to participation, such as travel and transport, and also allow CROs and sponsors to reach populations who would otherwise be unable to enlist.
#3 — Wearable technology
Many people are familiar with Fitbits, which track health metrics such as heart rates. But more and more “smart medical devices” are emerging, which CROs and sponsors can use to improve data collection for clinical trials.
Besides smartwatches that monitor heart rhythms, there are now wearable ECG and blood pressure monitor with sensors that detect cardiac activity. Then there are biosensors that collect data regarding movement, respiration, and temperature.
Wearable health tech can help people manage their health, but it can also allow CROs to enroll participants who may not have geographic proximity to report to a clinic in person. This widens their potential pool and provides more data that could lead to further progress.
#4 — Biosimulation
Biosimulation isn’t strictly new, but it’s risen in popularity. It uses mathematics-based computer simulations to replicate biological processes and systems. This allows researchers to gather and analyze data regarding biological systems without having to conduct tests on living organisms.
In terms of clinical trials, researchers can use biosimulation to replicate a human’s reaction to a certain treatment, which can help determine a certain drug’s safety and efficacy. It can also allow researchers to assess dosages for different demographics, drug interactions, and potential risks.
For CROs like BocaBiolistics that have their own biospecimen repository, they can provide samples for researchers to use in their biosimulations.
Using biosimulation versus in-human trials allows CROs to lower R&D costs, accelerate development-to-market times, and advance their understanding of diseases and biological processes.
Challenges for CROs Adopting New Technologies
While technology has revolutionized the clinical trial landscape, it still has its challenges, risks, and limitations. Mechanization is not omnipotent and all-powerful, and there are very real concerns that come with the use of these innovations.
#1 — Patient compliance
Plenty of these breakthroughs – such as decentralized clinical trials – require strict and transparent patient compliance to be successful. Trials that involve self-reporting and remote tracking cannot directly monitor a patient’s vitals and reactions, which means they rely on the honesty of these reports when collecting data.
If patients do not regularly submit their metrics and performance indicators, it would compromise the data and, therefore, the validity of the research. CROs will expend extra effort validating the data they collect and ensuring full patient compliance with the study’s process.
#2 — Accessibility
New technologies may enable CROs to connect with underserved populations, but that hinges on these populations being able to access these technologies – something that isn’t always possible. For example, not everyone has reliable internet or a smartphone that can run relevant applications. They may also not be aware that these studies are even taking place and that they’re eligible to participate.
There’s also an inherent distrust of medical research within these minority communities due to historical discrimination and exclusion. It’s essential for CROs and sponsors to build bridges to overcome these reservations and provide access to potential participants so the project developers can further their research.
#3 — User Adoption & Training
The success of technology adoption in clinical trials largely depends on user adoption and training. User-friendly technology is critical to maximizing user adoption, with intuitive software interfaces and navigation essential. Additionally, CROs should provide comprehensive and ongoing training to employees, covering the purpose of the technology, how it fits into the clinical trial process, and its benefits. Proper training and user adoption of new technology can reduce errors, improve efficiency, and enhance data accuracy. Insufficient training, on the other hand, can lead to low adoption rates, errors, and reduced efficiency. By prioritizing user adoption and training, CROs can fully embrace new technology and maximize its benefits, leading to better outcomes for clinical trials.
#4 — Associated costs
Ideas are free, but technology doesn’t come cheap. A CRO will need to be aware of the associated costs with using these technologies, including acquisition, maintenance, and execution. Take biosimulation, for example – what is the cost-benefit of using tech-powered trials versus in-human tests? Is it worth executing these trials in a simulated environment first before validating the results with controlled personal use?
New Opportunities: Can CROs Integrate AI into Workflows?
One hot technological innovation that’s revolutionizing different industries is AI – artificial intelligence. It’s become particularly prevalent in creative fields such as writing and digital art, with programs such as ChatGPT and DALL-E changing the landscape. But is there potential for AI in other fields, such as clinical research?
AI is already present in biosimulation trials, but its use can extend further. CROs can create “Synthetic Control Arms (SCA),” virtual representations of patients from different demographics based on scraped historical data. They can use AI to speed up administrative duties and paperwork. IQVIA, for example, features its Clinical Data Analytics Suite (CDAS) to allow sponsors to get more value out of their data. It uses AI and machine learning to generate actionable insights that improve outcomes for patients, sites, and sponsors alike.
Now, who knows what further AI breakthroughs will come in the future as the tech industry looks to improve that technology in the name of human progress?
CROs Powered by Technology
The advent of new technologies brings with it advancements to existing conventions alongside challenges to the execution. This is true for all industries, including clinical research. But CROs shouldn’t feel daunted by the emergence of new technologies – rather, they are something to embrace, integrate, and innovate in the name of progress.
Vial is a next-generation, tech-powered CRO that’s committed to executing clinical trials that lead to breakthroughs in biotech. Here at Vial, we’ve developed our own technologies to improve clinical trials, such as ePRO (electronic patient-reported outcome), EDC (electronic data capture), and eSource (electronic source).
If you are a sponsor of a clinical trial and want a demo of our different resources, contact us today!