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Five therapeutic areas that are apt for an all-virtual approach, and that can serve as an entry point for sponsors who are hesitant yet interested in exploring the growing DCT model.

Decentralized Clinical Trials: What Therapeutic Areas are Ripe for All-Virtual?

Video interview with Sepehr Shojaei, VP, Design Solutions, Lightship

Lightship's Approach to Accessible, Representative, and Impactful Clinical Trials

Lightship prioritizes patient accessibility and centricity in clinical trials, ensuring a seamless and positive experience for every participant. Learn more about:

Lightship's mission and core purpose as a company

How Lightship’s mobile nursing teams and home visits enhance study participation and retention

The role of mobile research units in the community and how they enhance participant education, accessibility, and convenience

Sepehr Shojaei, VP of Design Solutions at Lightship, talks about how the company works with pharma and contract research organization (CRO) partners to support clinical trials that are patient-first and accessible.

Latest Conference Coverage

Lightship’s Approach to Accessible, Representative, and Impactful Clinical Trials

Video interview with David MacMurchy, CEO of Lightship

Accelerate Inclusive Enrollment and Delivery with Lightship

Lightship focuses on patient accessibility and centricity in clinical trials, ensuring the patient experience is a positive one. Learn more about:

Lightship's impact on achieving diversity in clinical trials by engaging underrepresented patient populations

How Lightship utilizes hybrid and decentralized trial designs to reduce patient burden

The impact a patient centric model has on clinical trial participation and outcomes

David MacMurchy, Chief Executive Officer at Lightship, offers some insights into the company's mission toward improving equity and diversity in clinical trials. 

In a 5-4 decision, the Supreme Court has allowed the Trump administration to continue with funding cuts to medical research that aim to advance diversity, equity, and inclusion (DEI).

The 5-4 ruling by the justices lifted an order from June made by US District Judge William Young of Massachusetts, who ruled an earlier policy implementing National Institutes of Health (NIH) funding cuts to be unlawful. Young’s ruling forced the NIH to restore funding for over 1,700 grants in the areas of heart disease, HIV/AIDS, Alzheimer’s disease, alcohol and substance abuse, and mental health issues.

The deciding vote in the Supreme Court’s latest ruling on August 20 was made by Justice Amy Coney Barrett.

In a statement, Barrett said: "As today’s order states, the District Court likely lacked jurisdiction to hear challenges to the grant terminations, which belong in the Court of Federal Claims.”

She added: “The Government is not entitled to a stay of the judgments insofar as they vacate the guidance documents.”

Meanwhile, Massachusetts Attorney General Andrea Joy Campbell, representing one of 16 states against the NIH cuts, said she was disappointed by the Supreme Court’s decision.

In a statement, she added: "Even though the Court did not dispute that the Trump Administration’s decision to cut critical medical and public health research is illegal, they ordered the recipients of that funding—hospitals, researchers, and the state—to jump through more hoops to get it back. All the while, our research institutions, economy, and residents who depend on this lifesaving medical research will suffer.”

Impact on diversity and clinical research

The clinical research industry has been deeply impacted by 

—such as the turmoil around NIH grants and DEI initiatives—in 2025. These challenges date back to when the administration began taking steps to address DEI policies in clinical research earlier in the year.

Just days after taking office in January, President Donald J. Trump issued an executive order effectively banning federal recognition of gender identity apart from biological sex. In response, the FDA quietly removed a previously issued draft guidance on diversity in clinical trials from its official website.

Only weeks later, the NIH announced that it would cut “indirect expenses” in the funding it provides to research grants by nearly half. Immediately after the cut took effect on February 9, 22 states sued the NIH and the US Department of Health and Human Services, citing the cut as unlawful.

Industry perspectives on long-term effects

Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical research, emphasizing the importance of diversity-focused research.

“I don't see a way that walking back diversity requirements, walking back funding for research focused on diversity doesn't have a long-term impact,” he said. “Without direct investment in research into diverse populations, […] I think we really risk putting those populations further behind and increasing the care gap between the folks that aren't in those underrepresented populations and those that are.”

In terms of how the industry can continue to move forward and ensure that a steady pipeline of medical research is maintained, Ron Lanton, partner, Lanton Law, noted that researchers will have to view their trials through a more conservative lens.

, he said: “This entire situation is disheartening. It could halt many clinical trials focusing on minority groups and stifle progress on certain vaccines. This could lead to entire sectors of science receiving neither funding nor attention. I don’t think we fully understand the magnitude of this yet—it won’t be clear until it actually happens.”

1. Gerstein, J. (August 21, 2025). Supreme Court lets Trump admin cut off health grants it says advance DEI or ‘gender ideology extremism’. 

https://www.politico.com/news/2025/08/21/supreme-court-nih-funding-grants-00518782

2. Hurley, L. Grumbach G. (August 21, 2025). Supreme Court allows Trump's cuts to health research grants over DEI policies. 

https://www.nbcnews.com/politics/supreme-court/supreme-court-allows-trump-cuts-nih-grants-dei-policies-rcna222470

The Supreme Court's 5-4 decision permits the continuation of funding cuts to medical research aimed at promoting diversity, equity, and inclusion (DEI), reversing a previous ruling by US District Judge William Young. This decision affects over 1,700 grants related to critical health issues. Massachusetts Attorney General Andrea Joy Campbell expressed disappointment, highlighting the negative impact on research institutions and public health. Industry experts emphasize the long-term consequences of reduced diversity-focused research, potentially widening healthcare disparities and stalling progress in clinical trials targeting minority groups.

The Supreme Court has ruled 5-4 to allow the Trump administration’s NIH funding cuts to continue, impacting more than 1,700 medical research grants in areas including heart disease, HIV/AIDS, Alzheimer’s disease, and mental health.

Supreme Court Upholds NIH Funding Cuts Affecting DEI in Clinical Research

ImmunityBio has initiated a new Phase II study, COVID-4.019-Long (NCT07123727), to evaluate the safety and effectiveness of Anktiva (nogapendekin alfa inbakicept-pmln) in patients with long COVID.

The exploratory, single-arm study will look to recruit up to 40 participants who meet the World Health Organization (WHO)’s long COVID criteria. Its main objective is to evaluate the safety of Anktiva administered subcutaneously and has a key secondary measure of assessing the interleukin-15 agonist’s effect on absolute lymphocyte count. Other exploratory objectives include:

Evaluation of Anktiva’s ability to improve post-COVID natural killer cell and CD8+ T cell counts.

Assessment of the immunological function of NK cells and CD8+ T cells.

According to the CDC, long COVID is defined as a chronic condition following COVID-19 that is present for three months. It includes a wide range of symptoms which can emerge, persist, resolve, and reemerge over the span of weeks and months.

In a company statement, Patrick Soon-Shiong, MD, founder, executive chairman and global chief scientific and medical officer of ImmunityBio, said: “We are excited to study Anktiva for the treatment of long COVID, a substantial public health concern. Early in the pandemic, the common assumption was SARS-CoV-2 would prove to be a transient infection, as is the case with coronaviruses in general. But we now know viral nucleic acid and proteins can be in the gut mucosa months after infection. As such, an antiviral strategy looks insufficient to treat or cure long COVID. Based on clinical insights to date, we believe Anktiva may be a new therapeutic option for this chronic and potentially disabling condition by enhancing immune function, facilitating viral clearance, and addressing underlying contributions to long COVID.”

ImmunityBio is also supporting a separate Phase II study of Anktiva for the treatment of long COVID (NCT07108036), which will evaluate safety and tolerability.

Anktiva is already FDA-approved alongside Bacillus Calmette-Guérin (BCG) as a treatment for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

The approval was based on positive results from the single-arm, multicenter, Phase II/III QUILT-3.032 trial (NCT03022825). Results from a group of 77 patients who received Anktiva with BCG maintenance therapy for up to 37 months showed:

The complete response rate was 62% (95% CI: 51–73).

Among responders, 58% maintained a response for at least 12 months and 40% maintained a response for at least 24 months.

Tumor status was evaluated with cystoscopy and urine cytology and is continuing for up to five years following the beginning of each patient’s participation in the study.

In a company statement from the time of the approval in April 2024, Soon-Shiong said: "Anktiva not only proliferates and activates the patient’s own NK cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells. This novel mechanism of action, which mimics the biology of the dendtritic cell, begins the evolution of immunotherapy beyond T cells alone. The combination of the proliferation of key cancer-killing immune cells, together with the activation of T cells with memory, results in durable complete responses. The ‘triangle offense’ of tumor cell killing by the body’s immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumor types, regardless of the site of origin.”

1. ImmunityBio Announces Phase 2 Study of ANKTIVA® in Patients with Long COVID. News release. ImmunityBio. August 19, 2025. Accessed August 21, 2025. 

https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-phase-2-study-anktivar-patients-long-covid?field_nir_news_date_value%5bmin%5d=

2. Long COVID Basics. US Centers for Disease Control and Prevention. July 24, 2025. Accessed August 21, 2025. 

https://www.cdc.gov/long-covid/about/index.html

3. ImmunityBio Announces FDA Approval of ANKTIVA®, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer. News release. ImmunityBio. April 22, 2024. Accessed August 21, 2025. 

https://immunitybio.com/immunitybio-announces-fda-approval-of-anktiva-first-in-class-il-15-receptor-agonist-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer/

ImmunityBio has launched a Phase II study to assess the safety and efficacy of Anktiva in long COVID patients. The study aims to recruit 40 participants and will focus on Anktiva's impact on lymphocyte counts and immune cell function. Long COVID is characterized by persistent symptoms lasting over three months post-infection. Anktiva, already approved for bladder cancer, shows promise in enhancing immune function and facilitating viral clearance. The study builds on Anktiva's previous success in bladder cancer, where it demonstrated significant response rates and durable outcomes.

A new exploratory study will evaluate the safety of Anktiva in patients with long COVID, with secondary and exploratory measures focused on immune cell activity and function.

Phase II Trial Launches of Anktiva in Long COVID Patients

The desire to have greater control over clinical trial payments and strengthen relationships with investigator sites is driving some trial sponsors to consider bringing these responsibilities in-house using a software-as-a-service solution. However, such SaaS solutions are not a panacea for the complexities and requirements of clinical trial payments. This is why a hybrid approach makes sense for many sponsors.

When sponsors bring clinical trial payments in-house, they take on the full scope of that work. Certainly, a SaaS solution will do some of the heavy lifting, such as crunching the data and calculating payments owed to sites. But sponsors also need to manage the various technical and compliance challenges of clinical trial payments, which can require them to obtain resources for administering site payments globally as well as following country-specific processes and policies.

With the right balance of insourced and outsourced payment activities, sponsors can receive all the benefits of a SaaS solution while minimizing the risks and burdens that come with managing global investigator site payments internally.

Key considerations when insourcing payments

The main appeal of a SaaS solution is its ability to quickly and accurately determine site payments.

The solution should be able to consume all patient-visit and related clinical data, apply the financial terms for each site’s clinical trial agreement (CTA), and accurately calculate payments. The solution should also have an intuitive interface for sites to upload invoices and supporting documentation for CTA items that require it, such as archiving and pharmacy fees. Financial information should also be easily viewable for both the site and the sponsor in real time.

By doing this using a SaaS solution internally, the sponsor can own more of that crucial site relationship. For instance, if a site has a question about a specific payment or needs support at any time, they can contact the sponsor instead of a third-party managing payments. In addition to strengthening site relationships, this can help sponsors advance sponsor-of-choice initiatives.

However, the wrong SaaS solution can negatively impact site relationships.

Investigator sites are overburdened with technology provided by sponsors to support clinical research activities. They often use different portals for entering clinical data, tracking payments and getting regulatory approval to see patients. This challenge is exacerbated when sites work with multiple sponsors that each have their own technology preferences.

This is why it’s crucial that sponsors prioritize the site experience when selecting a solution.

For instance, a platform should make information readily available and easy to understand. It should automate as much of the payment-related work as possible, such as uploading invoices, reconciling final payments and managing accruals. 

For sponsors, it’s important to remember that a payment platform doesn’t operate in a vacuum. Its success depends on its ability to integrate with other systems, including clinical trial management systems, electronic data capture systems and financial systems. A SaaS solution that eases these connections, such as with API integration capabilities, can help sponsors save time and avoid headaches.

Sponsors shouldn’t wait until they bring payments in-house to understand how that change will impact staffing, internal processes and compliance or their associated costs. Instead, sponsors should conduct readiness assessments to identify these needs in advance.

A readiness assessment can reveal where a sponsor will need to revise roles. For example, they may need to adjust existing customer-facing positions to provide payment-related support to sites. Or they may need to create new roles to clean data so it can be processed by a payment system.

Understanding these impacts can help sponsors identify the payment responsibilities that may be too complex and costly for them to take on internally – and where outsourcing can be a lifesaver.

Facilitating payments across borders is a prime example of an activity that sponsors may want to outsource.

Countries around the world have unique requirements that must be met to successfully make investigator site payments. Some governments, for example, require that paying entities have a physical presence in their country. And in some cases, it can take several months to complete the work and secure the necessary regulatory approvals and bank relationships to meet just one country’s requirements.

Instead of putting this burden on their accounts payable departments, sponsors can give this work to a partner that already meets the requirements and has established banking relationships in the countries they need to pay into. This partner can do a final validation of payments and then handle all aspects of disbursing those site payments in each country.

Similarly, a trusted partner with global experience can help a sponsor use the optimal country-specific language that should be included in their global clinical trial agreement templates. This can help enable a smooth payment experience for both the sponsor and site, and support compliance with regulations that cover such things as research credits or value-added tax. The same partner can also help the sponsor comply with payment disclosure or “sunshine” laws in countries that have them.

All these areas where a third-party partner can offer support may not be immediately obvious to a sponsor. But when needs are identified through a readiness assessment, a partner can help sponsors avoid costly payment-related delays and disruptions.

Even with the assistance of a third party, the transition to managing payments in-house won’t always happen overnight. Sponsors may benefit from phased or managed migrations.

This can be an opportunity for the sponsor to learn and get comfortable with the new processes required by their SaaS solution while they continue to outsource payment-related activities. During this transition, their third-party partner can play the role of a consultant, answering questions and helping the sponsor ease into their new processes as payments are brought in-house.

Regardless of what migration looks like, the sponsor can enjoy the best of both worlds using a hybrid approach to payments. They can expect rapid and accurate payments from their SaaS solution while strengthening their relationships with sites. And they can lean on the expertise and global reach of a strategic partner to address technical and compliance challenges while reducing risk and resource demands.

Jim DiCesare, Vice President, Financial Management Solutions, IQVIA Technologies, 

is passionate about delivering innovative cost benchmarking, CTA negotiation and site payment services that support clinical research conducted by sponsors and CROs. With more than 25 years of industry experience leading clinical operations teams at Merck, DrugDev, and now, IQVIA Technologies, Jim has expertise across the contracting, budgeting and investigator grant payment management continuum. He is a frequent speaker at industry conferences and has written for a variety of publications. He has a B.S. in Accounting from Kutztown University.

Bringing some payment activities in-house while outsourcing others can help sponsors optimize clinical trial efficiency, reduce risks, and strengthen site relationships.

Why Sponsors Should Consider a Hybrid Approach for Clinical Trial Payments 

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how real-time data access is helping biotechs accelerate trial timelines, ensure patient safety, and gain greater oversight—especially through integrated CDMO and CRO partnerships.

Why Real-Time Data Visibility Is Essential for Biotech Clinical Trials

, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility in clinical trials, emphasizing the need for actionable data to meet aggressive timelines and budgets. Remote monitoring is crucial for quick decision-making and patient safety, reducing site burdens and leveraging advanced technology. Integrated systems help study sponsors meet evolving regulatory expectations by removing data silos and streamlining inspection processes. Barriers to real-time trial oversight include data silos and the need for integrated systems. Best practices for decentralized trials include unified data management, clear SOPs, and governance pathways to ensure operational alignment and regulatory compliance.

ACT: Why has data visibility become such a critical driver of efficiency and oversight in modern clinical trials, especially for biotechs?

I think for biotechs, typically what we're seeing now—and probably now, more than ever—is they have fantastic products that they've developed. They have very aggressive timelines, and they have budgets that they need to adhere to. The way that we think about data and how it enables biotech and enables the industry is, if you think about partnerships and multiple suppliers in the supply chain, the more data they can provide to the biotech, the more actionable data. It means that they can, live, make decisions that will help them accelerate their timelines, and conduct a successful clinical trial, but also keep the patient safe within the trial as well. At Thermo Fisher Scientific, the way we're addressing this is with our Accelerator™ Drug Development program, where we're combining CDMO and CRO services. That means you have consistency across the supply chain, and single data sources that we can provide to our biotech partners.

Dr. Pam Diamond

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