Is the success of clinical trials shaped by the technology patients use and could bespoke devices outperform consumer ones in delivering better data and experience?
Here in this comprehensive article for the summer 2025 edition of International Clinical Trials, Steve Sanghera, Co-Founder and CEO of Inventus, gives his verdict.
“The clinical trials industry is one of the largest and most influential in the world. It is the centre of excellence, bringing together leading experts dedicated to advancing life-saving solutions through improved drug development, manufacturing, preventative care and medical research, fields that collectively represent an investment of hundreds of billions of dollars annually.
However, none of this will matter if there is a lack of successful clinical trials. A key, but often forgotten, part of that is placing the right tools and technology in the hands of the participating patients and sites. This is where the creation of bespoke technology solutions and devices for clinical data trials takes the spotlight.
In the world of life sciences and clinical trials, the patient always comes first. Therefore, the beginning of the patient’s journey in the clinical trials space is when the technology is put in their hands to record their own data. This part of the clinical trials space is often overlooked. The point where the technology is handed to a patient taking part in a clinical trial is an ongoing issue and those working in the clinical trials space know the solution: bespoke technology that supports clinical trials to allow them to start and finish successfully.
An independent technology provider is needed, willing to create those bespoke technology solutions, a provider that now exists. Before touching on the merits of the bespoke technology solutions that now exist for clinical trials, it is important to discuss the context that prompted this vital change in technology. More often than not, a consumer mobile device was handed over to the patient, devices such as Apple or Samsung phones. It is clear how unsuitable they are for a clinical trial, as they can create many technical and supply chain challenges.
Consumer-manufactured products are not designed to meet the specific technical requirements or supply chain demands of clinical trials, differences in product life cycles being just one of many challenges. Clinical trial protocols require consistency, controlled software management and robust security, standards that are extremely difficult to maintain with technology built for the mass consumer market.
For example, Apple operates on a controlled IOS platform and no third party can obtain access to its operating system, other than Apple itself. For the technology placed in the hands of sites and patients, this is not ideal. It can cause issues for the design protocol. In the context of a highly regulated clinical trial, especially when it comes to capturing patient data, lacking control over the patient’s device presents significant challenges. Inability to modify software, apply timely security patches or manage mandatory updates can all introduce risk. Experts consistently highlight that the more uncontrolled changes within the deployed technology stack, including devices, the higher the likelihood of disruption or failure in a clinical trial.”
The sanctity of data
“Corruption of data, meaning that the data cannot be used in the clinical trial, is a huge issue for pharmaceutical companies and even a patient’s lack of understanding of the technology can eliminate them from a trial. The average loss to a clinical trial of a patient either walking away or the data no longer being valid is approximately $50,000[1].
It is unrealistic to expect manufacturers of consumer devices to tailor their devices or create bespoke ones for such a niche market – there’s no return on investment for them, as the overall numbers are tiny.
What it needs is an independent technology provider willing to take the risk, create those bespoke technology solutions needed for the clinical trials space – willing to be an original equipment maker (OEM) for the clinical trials space.
The average length of a clinical trial is more than four year and there are many that can last a decade. The consumer market will change its devices every year, but clinical trials don’t want that. They want consistency for good reasons. The bespoke technology that has been created for the clinical trials space has a simple replaceable battery, which is very important for longevity and its lifespan.
Over 42% of all faults on a mobile device are battery related[2]. The bespoke technology solutions created for clinical trials are designed to offer the latest technology combined with simplicity of design for patients to use. The bespoke technology solutions provide accuracy, consistency and validation, which is what the life sciences industry wants.
If bespoke technology solutions developed by the OEM are not being used, then the alternative is typically an adapted device or software, which raises the question: how can this approach offer the same level of performance or suitability?
Every component of a tech stack provided by a dedicated OEM, whether hardware, software, connectivity, device management platforms or warehousing, has been purpose-built to align with the specific design protocol of a clinical trial. In contrast, most other technology providers in the market typically offer adapted or repurposed solutions. The issue with this? The products and services have not been designed for any particular purpose or, more significantly, a designed protocol of a clinical trial.
A great example of a technology solution created by the OEM is connectivity. There is not an individual mobile carrier that covers the whole world. However, clinical trials are global, so connectivity is critical for patient and site experience. A clinical trial protocol was crying out for a consistent global platform; one provider, a carrier agnostic in all regions, which allows the best connectivity available to patients and sites. A Global Clinical Data Operator (CDPO) such as this is now becoming available. This means that clinical trial partners do not have to work with, manage and negotiate with multiple different carriers.”
What does the future hold?
“The technology created for clinical trials is very much phase one of the journey. Phase two will see new technology that will be built to create better data collection, focusing around connected health, patient recruitment, preventative health and preventative care. It’s certainly a very exciting time to be working in the clinical trials space.”
[1] sofpromed.com/ultimate-guide-clinical-trial-costs?utm_source
[2] sciencedirect.com/science/article/abs/pii/S0959652624040940?