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Clinical trials are a foundational factor in modern drug development. This research helps biotech and pharmaceutical companies guarantee that investigational new drugs are safe and effective treatments across modalities.
Today, biotech organizations are increasingly focused on bringing cutting-edge therapies to market, often for underserved patient populations, such as those with rare diseases.
According to recent data, biotech organizations accounted for less than 10 percent of drug approvals in 2015; however, today they account for over 30%. This illustrates the increasingly important role biotechs are playing in the development of critical drugs and therapies.
Simultaneously, biotechs are facing mounting funding pressures and changing patient expectations. These factors have forced them to rethink how they design, package, and deliver studies that bring crucial medications to market, which challenges the traditional clinical trial model.
In recent years, we have learned that decentralized clinical trials (DCTs) can help overcome many of the hurdles. This model offers greater flexibility through reduced site visits, lower site-management costs, minimized site-related delays, and real-time data capture enabled by digital tools.
Yet, with these benefits come new operational and regulatory complexities, particularly for biotechs who often need support managing their clinical infrastructure. This is where contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) come into play.
CDMO/CROs can help biotechs navigate the transition from traditional clinical trials to DCTs by providing expertise across the entirety of the drug discovery and development process, through clinical trials and into commercialization.
DCTs offer several benefits for biotechs compared to the traditional clinical trial model. First and foremost, biotechs can expand patient access, which means there are far fewer barriers preventing patient participation. This is a game-changer for patients who live far from large, urban medical centers where clinical trials are typically held, and for patients with rare diseases.
DCTs also offer clinical trial operators improved efficiency throughout the process. When biotechs can reduce the need for site visits and the administrative oversight that requires, timelines for getting a drug through the trial and into market shorten as coordination is simplified.
Much of this is enabled by recent technological innovations, including artificial intelligence (AI) and machine learning (ML), which allow for faster and more consistent data capture.
Finally, for smaller biotechs that are still establishing their processes, DCTs also provide budget flexibility. They can save costs on site management, travel arrangements, and logistics, which can then be reinvested into what really matters: science and innovation.
While recent studies show several key advantages for biotechs in adopting DCTs, there are still significant barriers to widespread industry adoption.
A common challenge is collaborating with multiple vendors throughout the process without a central administrative location. Biotechs may work with separate vendors for handling patient information, interactive response technology providers, courier services, distribution centers, and medical adherence.
If there’s a lack of integration across all parties, such as when each vendor has their own software or ways of communicating key information, there’s a risk of vendors receiving inaccurate information or not enough data visibility to make informed decisions about moving the drug candidate forward. For some biotechs, these challenges require alternative solutions, like partnering with a CDMO/CRO with end-to-end capabilities and services.
While next-generation technologies, such as AI/ML, have made remote monitoring and data capture more consistent and reliable, biotechs are still figuring out how to integrate them across operations.
With more technology in the mix, better connection is required. This can be a massive undertaking when one trial requires multiple data systems, such as electronic health records, eConsent platforms, and wearable devices.
This example clearly highlights some of the operational complexities that can hinder DCT trial efforts. Required activities like packaging materials, proper labeling, and facilitating direct-to-patient shipments all require robust logistics management. Clinical trials are always complex, but DCTs demand additional coordination to ensure success.
For small biotechs that are early on in establishing their presence throughout the industry, these challenges can feel intimidating, sometimes even impossible, to work through. However, partnering with a company that offers integrated CDMO/CRO services under one roof can dramatically change how biotechs approach DCTs.
With all-inclusive oversight throughout the entire drug development, manufacturing, and commercialization process, data moves seamlessly from stage to stage, reducing fragmentation and inconsistencies, strengthening decision-making, and reducing timelines.
For example, a biotech was recently conducting a global Phase 3 pediatric study involving a temperature-controlled investigational medical product solution that was packaged in bottles with multiple ancillary supplies. Because patients required enough materials for three months, the study required frequent medication allocation and coordination across all trial participants.
By partnering with a CDMO/CRO, the company was able to implement a clinical site-to-patient model that provided greater flexibility to patients and their families. They could choose whether they wanted to take home the required materials during the first visit or have them delivered directly to their home. This ultimately reduced the need and burden of transporting temperature-controlled supplies independently.
This example shows the positive impacts of partnering with an integrated CDMO/CRO while navigating the complexities of DCT. First, CDMOs consolidate manufacturing, packaging, labeling, and logistics, creating support for both hybrid and fully decentralized trials.
Second, the right partner offers the specialized expertise needed to execute direct-to-patient services for temperature-controlled therapies safely and reliably. Finally, CDMOs strengthen operational continuity by managing global networks, coordinating across sites and couriers, and preventing disruptions before they jeopardize study progress.
Ultimately, the future of DCTs will depend on collaboration between organizations, clear regulation, and a deep commitment to expanding access. Both biotechs and CDMO/CROs must work as a unified ecosystem by aligning trial design, logistics, and data oversight to make the decentralization of clinical trials a truly sustainable option.
Regulators like the FDA are increasingly supportive of these models, but they continue to stress the key factors that must be taken into consideration: data integrity, patient safety, and strict protocol adherence.
Above all, biotechs and companies working to get their drugs into the hands of patients should recognize DCTs as an opportunity to expand access, enabling participation from patients who have long been excluded due to geography, mobility constraints, or lack of resources. These models will shape a more inclusive, efficient, and resilient future for clinical research.
