Building Operational Visibility in Clinical Trials: Q&A with Deepak Prakash

New technology provides members of the industry with the ability to collect and sort data at a significantly higher scale than ever before. While this provides many opportunities, it’s also possible for key data to get lost in the noise.

These same new technologies also allow for more complex systems and designs to be created. As a result, the industry is expected to do more and go further than in previous years.

Deepak Prakash, VP of healthcare at Identiv, spoke with Pharmaceutical Executive, about how all of this is impacting clinical trials. According to him, modern trials are able to use these new tools to sort mountains of data and predict potential problems with more accuracy while the trial is still being designed.

Pharmaceutical Executive: Why is operational visibility becoming a limiting factor as trials scale?
Deepak Prakash: Operational demands in clinical trials have outpaced the systems used to manage them. Studies now span multiple countries, decentralized patient populations, and tightly coordinated workflows across sites, labs, and logistics providers. Protocols are more sensitive to timing, handling conditions, and data accuracy at every step. Much of the underlying infrastructure, however, still depends on disconnected systems, manual data entry, and point-in-time updates.

That creates the real visibility problem. Key signals – whether a patient took a dose, where a sample is in transit, whether it remained within required temperature ranges, or how a site is performing – are captured intermittently. Records reconciliation is often an additional burden on time and cost.

That lack of continuity makes it harder to detect issues early or understand how they propagate across the trial. At that level of complexity, the impact extends beyond efficiency to data integrity, trial outcomes, and operational consistency.

PE: How has RFID and Bluetooth-enabled tracking become foundational to scalable, modern trial execution?
Prakash: The shift isn’t about collecting more data; it’s about capturing it differently and efficiently.

RFID and Bluetooth-enabled technologies attach data directly to physical assets, allowing packages, samples, and devices to carry their own record of location, status, and condition as they move through the trial. That creates a continuous view of activity across workflows that were previously fragmented. Instead of reconstructing events after the fact, teams can observe what’s happening as it unfolds and respond in real time.

This ultimately changes how systems operate. Manual reconciliation decreases, data becomes more reliable, and information begins to align across sites, labs, and sponsors. Because that same infrastructure supports multiple workflows, it allows trials to scale in complexity without adding operational burden.

PE: How are connected supply chains reducing disruptions and drug waste?
Prakash: Nowhere is the impact of continuous visibility more immediate than in the supply chain. For therapies that depend on strict environmental controls, even small deviations in timing or temperature can lead to loss, contributing to an estimated $35 billion in annual losses tied to failures in temperature-controlled logistics (IQVIA Institute, as cited in the 2019 Biopharma Cold Chain Logistics Survey, p. 3). Traditional checkpoint-based tracking leaves much of this risk unobserved in transit.

Continuous tracking introduces a renewed level of control. Product condition and location can be monitored throughout the journey, making it possible to identify issues as they develop and intervene earlier.

This is largely visible in the pharmaceutical cold chain, where monitoring is moving to the item level. Sensor-enabled labeling combined with cloud-based systems allows each unit to be tracked and evaluated individually. In practice, this includes work with Identiv’s partners such as Tag-N-Trac, where continuous condition tracking helps maintain product integrity across the full distribution lifecycle.

As a result, supply becomes more closely aligned to patient demand, disruptions are easier to manage, and losses tied to spoilage or misalignment are reduced.

PE: Where is real-time tracking strengthening sample integrity and supply chain coordination?
Prakash: Sample handling introduces a different kind of risk. Biological materials are highly sensitive to time and environmental conditions, yet their movement and documentation is fragmented. That leaves limited visibility into how samples are handled between collection and analysis.

Real-time tracking adds continuity to that process. Location, condition, and chain-of-custody data create a verifiable record of how each sample moves through the system.

This shared view improves coordination across trial sites, labs, and logistics providers, while also changing how issues are addressed. Rather than identifying problems after sample integrity has been compromised, teams can intervene during transit or processing and shift toward more proactive management.

PE: How are digital labeling and packaging improving usability in decentralized trials?
Prakash: As trials extend beyond traditional sites, core study activities align better with patients, increasing their direct role in participation and data capture. That drives clarity and usability, central to both adherence and data quality. When instructions are difficult to follow or easy to misinterpret, variability increases.

Digital labeling and smart packaging address this at the point of use. Packaging can capture dosing behavior and environmental conditions, whereas labeling can deliver instructions in more accessible formats – through audio, translation, or enhanced readability.

These changes reduce reliance on manual reporting and make interactions with therapies more intuitive. More consistent patient behavior leads to more reliable data, which becomes increasingly important as trials become more distributed.