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September 4, 2018updated 03 Dec 2018 10:43am

Industry Viewpoints: Refining Your Outsourcing Strategy

Nadia Salem, Senior Director Medical Affairs, Leadiant Biosciences, explains to CTA’s Elizabeth Williams the keys to enhancing your outsourcing strategy

The increasing costs of running clinical trials puts more importance on choosing the right outsourcing partner than ever before to ensure budgets and timelines are met.

Discussing how to nail the fundamentals of selecting the right CRO partner will ultimately pay dividends in the conduct of the trial in question.

In this Industry Viewpoint, CTA’s Elizabeth Williams speaks to Nadia Salem of Leadiant Biosciences to gain insight into how to effectively outsource clinical trials, and how sponsor-CRO partnerships are evolving.

Elizabeth Williams: When it comes to outsourcing clinical trials, what would you class as the main ‘pain points’?

Nadia Salem: I think the biggest challenge is typically, we outsource almost everything from data management to biostatistics, drug packaging and even for the CRO that we select to run the trials. The biggest challenge other than quality, is turnover.

After 10-12 months, a project manager can leave, presenting a huge dilemma for the trial sponsor. As a result, a thorough handover must be put in place to avoid any issues.

Additionally, for small companies especially, there can be a discrepancy in receiving the ‘A’ or ‘B’ team, depending on how big your project is. Sometimes you find you’re working with a team that has varying levels of experience and managing them can be challenging.

EW: How do you tackle this and what pitfalls should sponsors be aware of?

NS: One of the things we do, whenever we use good providers, is we keep using them. If the team is experienced and good at what they do, we form strategic partnerships across all our trials.

EW: What are the key benefits from forming strategic partnerships?

NS: Mostly it comes down to a cost factor because it takes more time to develop these relationships. That said, as a result, your timelines can be more accurate and sometimes enrolment can benefit.

We had a bad experience once where we had to change CRO mid-trial and went to another provider. This meant initiating everything from scratch. Timelines are connected so it becomes more expensive and also more time-consuming as the sponsor has to oversee and ensure the transition is smooth.

EW: How do you establish effective communication channels as a study progresses to ensure milestones are met?

NS: The key here is to align the needs of both the sponsor and the CRO. Every CRO will have a method to kick start a study, however, as a study progresses those initial discussions are lost and that is where the communications struggles begin, meaning goals aren’t met as a result.

EW: What are the main issues your CRO could help you tackle?

NS: Patient recruitment, among others. It’s more and more difficult to find patients in all therapeutic areas. For a small company, we look to CROs that can provide solutions to increase recruitment and retention. If a sponsor and service provider can operate together effectively on enrolment, it’s possible to overcome what is an enduring problem.

EW: Lastly, how does your site help tackle patient recruitment?

NS: When working in a certain therapeutic area, you know who the performers are – you have the consultant, key opinion leaders and of course the site staff. It’s vital the sponsor follows their opinions as each stakeholder and each party can provide valuable input in how to recruit the right patient.

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