If you are a sponsor navigating your way through a growing trial, how do you ensure you have everything in place to accommodate the study’s needs? Some of the typical challenges that alter the course of a trial include changing enrolment criteria, an increase or decrease in subject enrolment, expanding countries or regions, all to name a few.

A sponsor company has to develop a strategy that accounts for all scenarios, should the unlikely occur. It’s all about making the right choices; sponsors must have the right people in place with experience and knowledge on how to deal with difficult circumstances in order to mitigate them. To ensure your trial is successful, sponsors must have these key attributes: speed, flexibility, consistency, acuity, and ingenuity. So often when a trial is terminated due to poor enrolment and retention rates, the root cause of the problem can traced the outsourcing strategy the sponsor implemented. With a majority of sponsors big and small outsourcing many aspects of their trials, the importance of having an effective outsourcing strategy cannot be overstated.

So what should be outsourced? Which capabilities are core to keep in-house? To what extent should you, the sponsor, outsource the remaining activities? Which activities should be outsourced by study versus by function? And at what cost would it be to the organization? Here are three things to consider:

  1. Determine what are your company’s core activities vs. your non-core activities

This is an issue most companies should consider when embarking on a trial. For sponsors who can’t execute global trials, they often depend on CRO partnerships, and it is vital in everything they do. Therefore, it is essential clinical study teams assess what needs to be outsourced. What are the core activities that can be carried out in-house? Furthermore, what are the non-core activities that require outside expertise? The core activities carried out in-house must be actions that cannot be equalled or surpassed by CROs or other partners, such as your program and project management, or your clinical and regulatory strategy. However, if there are aspects to the study that aren’t common across the industry then sponsors should outsource it. Bear in mind that before a trial begins, sponsors must tailor their outsourcing strategy with their overarching business model.

  1. Be aware of typical outsourcing failures

In order to develop an effective outsourcing strategy, sponsors must acknowledge what can lead to a failed outsourcing strategy. For instance, poor vendor identification, selection, and negotiation are the hallmarks of a failed strategy. Additionally, ineffective project budgeting, financial management, and change control are contributing factors as well. In a lot of cases, vendors are not governed by established performance criteria, which often lead to confusion about expectations within third party teams. What’s more, the sponsor staff may lack the requisite experience needed to manage vendors, highlighting the issues caused by a lack of established processes. In summary, having ineffective processes in place can ultimately result in a breakdown in vendor relationships. By being aware of the pitfalls of a failed outsourcing strategy, sponsors can put together plan that will stand them in good stead.

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  1. Have the right people in place, build strong relationships

For every clinical trial, its success can boil down to five factors:

  • The Product
  • The Program
  • The People
  • The Process and
  • The Partnerships

While the product and the program are important, it is the people, the process you implement, and the partnerships you strike that are instrumental to reaching the trial’s endpoint. Therefore, sponsors should invest time to realize a positive outcome in a growing trial. Remember your team will likely comprise of people of different ages and generations, so open communication among all the stakeholders involved is vital. Capitalise on the strengths of your team and build on their weaknesses. Setup a governance committee and engage country managers at all your sites. But most important of all, sponsors need to be transparent from the beginning while stating expectations. Put in place a framework that’s flexible and will enable you to manage more effectively. To that end, manage what is essential while sharing the risk and reward across your team. Naturally, unforeseen circumstances will come up, which can be overcome with good communication and governance. Most importantly, have the right people; effective collaboration will yield the best results.

 

 

References

Gavin Choy, Galena Biopharma, ‘Developing Your Outsourcing Strategy as Your Trial Progresses to Accommodate the Needs of a Growing Trial ‘ (Presentation)

Source: MacAllister et al. 2009. Contract Pharma