How Can Smarter Sample Collection Empower Patient-Centric Trials?

Today’s clinical trial models must balance scientific rigor, regulatory compliance and patient convenience. One promising approach is decentralized sample collection, including home nursing visits, which helps reduce patient burden. At the same time, it upholds high data quality and maintains Principal Investigator (PI) accountability.

Home visits can be a powerful way to reduce barriers to participation, especially for patients who face geographic, mobility or scheduling challenges. However, their success depends on a robust operational framework that preserves the same standards of oversight and safety as in-clinic visits.

In this Xtalks Spotlight, Colleen Gosa Nalepinski, Patient and Site Centric Solutions Strategy Director at IQVIA, shares how decentralized models can be designed to serve both patients and investigators.

With over a decade of expertise as a PI and Sub-Investigator at a Phase I research site, she specializes in first-in-human trials, thorough QT studies, single ascending dose (SAD)/multiple ascending dose (MAD) trials, pharmacokinetics and biosimilar trials.

Colleen explained how thoughtful planning, credentialed staffing and structured delegation can ensure safety, compliance and flexibility in remote settings.

Decentralized models empower patients while giving investigators visibility, setting a new standard for patient-centered research beyond traditional trial infrastructure.

Patient Safety First: How Home Visits Stay Compliant

When clinical trial visits shift to the home setting, maintaining patient safety and regulatory compliance remains essential. At IQVIA, each protocol undergoes a thorough feasibility review to determine which procedures can be safely and appropriately conducted outside the traditional site.

“Patient safety is our top priority when we’re reviewing protocols for home visits, both for feasibility and for the actual execution of the home visits. Patient safety and PI oversight go hand in hand.”

— Colleen Gosa Nalepinski

To support that oversight, IQVIA equips PIs with credentialing packets for each research nurse, including CVs, training records and prior trial experience, ensuring informed delegation decisions.

“All of the nurses that IQVIA offers to the sites have proper education, training and experience to be listed on the delegation log,” Colleen explained.

Additionally, IQVIA’s Decentralized Clinical Trials (DCT) Regulatory team reviews and confirms that home nursing is allowed under the laws and regulations of each participating country. This multi-layered framework ensures that even outside the clinic, trials remain compliant with GCP standards and fully aligned with PI responsibilities.

Balancing Nurse Autonomy with PI Discretion

When clinical visits take place in the home, nurses must be empowered to act independently while staying within the boundaries of their delegated responsibilities.

Striking the right balance between nurse autonomy and PI discretion is key to maintaining patient safety and trial compliance.

“A lot of that comes back to comparing the remote home nurse to the study site nurse,” said Colleen. “So, the nurse is leveraging their clinical skillset while completing a home visit, and they’re using their skills to determine whether or not the site needs to be contacted.”

For example, if a nurse observes something clinically concerning during a physical assessment, they are trained to act appropriately. “If a nurse is completing a physical assessment and they notice an area that is warm to the touch and perhaps erythematous, they’ll use their clinical judgment to decide whether or not the site should be called,” she explained.

Adverse event (AE) documentation is a critical area where clearly defined roles are essential.

During home visits, nurses are responsible for collecting information about any new or ongoing signs and symptoms reported by the patient. However, the authority to determine whether those symptoms qualify as an AE — and to assign the appropriate term, severity and causality — remains solely with the PI.

This ensures that clinical judgment is used appropriately and that trial data remains consistent and compliant across both site-based and home-based settings.

Making Home Visits Work with Local Labs

Even when a study requires the use of local laboratories, home visits can still be a viable option.

IQVIA works closely with sites to ensure that decentralized sample collection aligns with local lab requirements, particularly when timely analysis is needed to inform patient care or enrollment decisions.

There are three key factors considered to ensure the feasibility of using home visits in studies that require sample analysis at local labs:

• Whether the site lab will accept samples collected outside its facility, as not all labs allow specimens that weren’t drawn onsite, so this is the first step in assessing compatibility
• Any specific labeling or tube requirements, because sample tubes must match the lab’s processing capabilities, including any specialized barcoding or device compatibility
• The lab’s operating hours, as home visits must be scheduled to ensure that samples can be transported and received on time

“If a lab closes at 5 PM, we’d schedule home visits in the morning so that samples can arrive in the afternoon,” said Colleen.

By coordinating these operational details in advance, IQVIA ensures that home visits support, rather than disrupt, the clinical workflow, maintaining both data quality and patient convenience.

Patient-Centered Design, Investigator-Led Decision Making

Home visits are not a one-size-fits-all solution, and that’s precisely the point. They offer a flexible, adaptive model that respects patient preferences while ensuring that clinical oversight remains firmly in place.

“It’s a great solution that allows patients to express what their wishes are, but it still has that PI oversight.”

— Colleen Gosa Nalepinski

The process begins with the patient expressing interest in home visits as a way to reduce the burden of travel. But the final decision — and any future adjustments — rest with the PI, who must assess whether home-based care is appropriate for each individual and for each phase of the trial.

And that PI decision can change over time. If a patient’s condition or risk profile evolves, the PI may determine that in-person visits are more appropriate going forward.

“For example, the patient I talked about earlier who had the area of erythema that was warm to the touch — it can go from a patient having visits in the home to the Principal Investigator saying, you know what? Let’s take away that option at the following visit because I’d like you to come to the site and I’d like to see you in person,” Colleen described.

This built-in flexibility supports more personalized care pathways while maintaining trial integrity.

As Colleen explained, DCT elements, particularly home visits and remote sampling, can be fully compatible with traditional principles of oversight, safety and compliance.

With credentialed staff, structured delegation and local lab coordination, these models are not only feasible but are also reshaping how trials can be run.

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.