The Role of Outsourcing in Biotech Clinical Trial Execution

In the photo: Claire Riches and Carrie Melvin

Carrie Melvin, head of Clinical Operations and Data Management at Lantheus, talks about the changes she has seen in the biotech space around trial execution in the past 10 years. She also shares what 2026 looks like in terms of relationships with suppliers.

Citeline’s “Small Biotechs, Big Decisions” podcast features interviews with leaders in the biotech space. Currently in its second series, the podcast has covered a range of topics, from board makeup to how to derive ROI from investments.

Our latest podcast looks at the changing face of biotech clinical trial execution, focusing on outsourcing. “Let's face it,” said host Claire Riches, Citeline VP of Clinical Solutions. “It's an expensive business.”

Riches was joined by industry veteran Carrie Melvin, Head of Clinical Operations and Data Management at Lantheus, the leading radiopharmaceutical-focused company. Melvin agreed that drug development is very expensive. “Companies are trying to balance that benefit, risk, that cost, and then at the end of the day, what their revenue will be, because the revenue coming in feeds the research.”

When asked what changes she has seen in the biotech space around trial execution in the past 10 years, Melvin said, “We definitely outsource in biotech. We don't have the infrastructure that large pharma might have. … I'm a firm believer too, even if you outsource, you as the sponsor, are ultimately accountable.”

She added that “one thing that I think we don't talk enough about is the fact the needle has not moved on the number of patients or people that join clinical trials.”

One way Melvin said Lantheus addresses this problem is working with patient advocacy groups. “We do try to work with patient advocacy groups to look at our protocol. Is our protocol too burdensome?”

“Such a good point,” Riches said about the lack of participation. “We spend so much time talking about providers and SOPs [standard operating procedures] and how we get from A to B as swiftly with low risk. But actually, if people, patients, participants, aren't on board with taking part in a clinical trial, all of that's in vain.”

Returning to the topic of outsourcing, Riches asked Melvin what she looks for in a contract research organization (CRO).

Melvin said it depends on the study, but, in addition to transparency, she’s looking for a CRO to bring its A game. “I am looking for, first and foremost, the partnership. Can we build a very strong partnership? And I mean, they have skin in the game. … I'm asking them to act on my behalf. If I don't make them feel that they're part of the team, and I keep them at a very tactical level, I don't think I can expect much more than them being very tactical. If I tell them to do A and B only, then they're only going to do A and B. But if I really spend time up front building a very strong relationship with them, then they feel invested in this program as well.”

Riches said it is “really important to treat partners as investments, actually, rather than invoices.”

Melvin continued: “I want to see that they've really looked at the protocol. I want to see that they're being creative. … Tell me what you're going to solve for us.”

Riches pressed Melvin for more details: “How do you make those decisions about which model to follow when you're outsourcing?”

“I do think that it's a cross-functional team decision,” Melvin said. “It's not just the clinical operations head or the clinical operation protocol lead. ... You have to have oversight.”

Riches agreed. “I think the best project managers, the best CROs, are the ones who say, ‘Look, a level set. This isn't working. But we've thought about this, and we think if we do X or Y, it's going to be easier for you, it's easier for us.’”

Melvin said she is a fan of pay for performance, tied to benchmarks like getting the first patient in and then getting 50% enrollment. “I think it helps them be more accountable to trying to help the study move along quickly.”

Riches pivoted to the topic of using real-world data (RWD) to find information on patients such as where they are and what their patient journey is. “Data's not great,” she said, “until you can actually extract the insights from that data.”

Melvin said another factor to consider is how old the datasets are. “That's where we can use some of the AI materials,” she said, “to help we find all that data, and to comb through that data. … When is this cumulative? Cumulative from what sources?

“The risk is everywhere. How do I limit that? … Drug development is a risky business. But how can I try to contain that risk and have more benefit versus risk?”

“It's a minefield, isn't it?” Riches said.

Riches asked Melvin what 2026 looks like in terms of relationships with suppliers and what advice she would give to someone starting out in a position similar to hers.

“I can't think of one [trial] off the top of my head that has gone exactly as I planned it,” Melvin said. “Ultimately, that protocol sits with you as the sponsor. You know you need to design that to be practical, adaptable.”

Melvin said the key is how to be as efficient as possible. “Be willing to be flexible and adaptable and efficient and logical in your thought process.”