Decentralized clinical trials: A game changer for biotech drug developers
Clinical trials are the foundation of modern drug development, helping to ensure investigational new drugs (INDs) are safe and effective for human use. Without them, FDA approval of new biopharmaceutical products would be impossible. However, biotechnology companies today face growing challenges—from investor funding constraints to shifting patient expectations—that threaten the traditional clinical trial model. Thankfully, change is underway.
Decentralized clinical trials (DCTs), in particular, have gained significant traction in recent years, offering more flexible and patient-friendly approaches by relocating certain activities away from traditional trial sites. While remote and hybrid models have been explored for more than a decade, their adoption accelerated during the COVID-19 pandemic—showcasing that decentralized elements can improve access and efficiency, as well as enhance patient retention.
For biotechnology companies—particularly those developing treatments for rare diseases or serving geographically dispersed patient populations—decentralized clinical trials (DCTs) offer distinct advantages.
Benefits of decentralized clinical trials for biotech companies
Conducting clinical trials presents unique challenges to emerging biotechs. Many of these companies focus on rare diseases, defined in the U.S. as conditions affecting fewer than 200,000 people, and these limited populations complicate patient recruitment and trial execution.
Additionally, smaller biotech companies typically don't have the big budgets for blockbuster drugs that their larger counterparts do. And for certain biologics—particularly autologous cell and gene therapies—using a patient’s own cells or genetic material adds complexity to trial logistics.
In light of these constraints, DCTs can provide significant value by addressing both operational and resource-related challenges. Below are some of the most important advantages they offer:
- Reduced need for site visits, making it easier for patients to participate and thereby improving recruitment and retention rates.
- Lower costs associated with site management, travel reimbursements, and administrative overhead—helping companies stretch limited budgets further.
- Minimized site-related delays and increased automation of data collection and patient monitoring—ultimately accelerating trial timelines.
- Greater operational flexibility and reduced logistical complexity through virtual visits, remote monitoring, and at-home sample collection.
- Technology-enabled real-time data capture through digital tools like wearable devices and mobile apps—enabling faster, more informed decision-making.
Key considerations for biotechs adopting DCTs
While DCTs offer numerous advantages, they also introduce operational and regulatory considerations that require thoughtful planning—particularly for companies building out their clinical infrastructure. With the right coordination, these challenges are manageable and often well worth the effort.
For example, elements such as direct-to-patient drug delivery, in-home health services, and remote sample collection require careful logistical oversight. Regulatory compliance is another essential factor, including adherence to data privacy laws and Good Clinical Practice (GCP) standards.
Because DCTs rely heavily on digital platforms, ensuring data security and system interoperability is also critical. Platforms must integrate with systems like electronic health records (EHRs) and electronic data capture (EDC) tools to maintain visibility, efficiency, and confidentiality across trial sites and participants.
Although implementing these systems may seem daunting, experienced partners can simplify the process—helping biotech companies adopt decentralized models confidently and effectively.
Innovations paving the way for clinical trial improvement
As DCTs gain momentum, a range of innovations is helping to streamline operations and improve trial execution across the industry. These tools and technologies are particularly valuable for organizations operating with leaner infrastructure or managing complex clinical needs—common scenarios in early-phase development.
- Integrated packaging and labeling solutions help streamline processes, ultimately saving time and reducing costs. Innovations like tamper-evident cartons protect the safety and integrity of sensitive biologics.
- Cold and ultracold supply chain management ensures the safe and efficient delivery of temperature-sensitive therapies directly to patients' homes. Many offerings range from ambient to ultracold conditions.
- Direct-to-patient services deliver your investigational products and ancillary supplies directly to patients’ homes and must be supported by global logistics, risk management, and coordinated communication.
- Smart packaging solutions support medication adherence by monitoring patient dosing patterns and ensuring protocol compliance in decentralized clinical trials, which often involve limited in-person interactions.
- Real-time tracking solutions safeguard the integrity of clinical trial materials by monitoring shipment conditions—such as temperature and location—to proactively prevent excursions and delays.
The future for decentralized trials
Decentralized and hybrid clinical trial models are becoming increasingly important in biotechnology research, offering efficiencies that help streamline operations and accelerate development timelines. As the industry continues to evolve, the adoption of these models is expected to expand, improving patient access and enhancing trial flexibility.
CDMOs are key partners in enabling this shift. Their expertise in cGMP-compliant manufacturing, direct-to-patient services, and temperature-sensitive logistics helps ensure INDs reach patients safely and reliably. With scalable, adaptable solutions, CDMOs also support evolving trial designs, enabling sponsors to maintain both quality and compliance as studies progress.
Download our case study to see how Thermo Fisher Scientific’s direct-to-patient services ensure safe and secure medication delivery for patients in decentralized clinical trials.
