Pharma and biotech companies are spending more on outsourced services now than ever before. And there are no signs of this trend stopping: pharmaceutical outsourcing is predicted to double in size to over $40 bn by 2026.
What’s driving this change? With companies under pressure to reduce costs and timelines, many small biotechs are turning to contract research organisations (CROs) for faster and more cost effective drug development. Outsourcing can give small biotechs and startups additional flexibility and access to a wider and more varied range of expertise than they might have in-house.
When it comes to finding an outsourcing partner, there’s a wide range of choice available. CROs vary in size, from small specialist companies offering niche services all the way to large companies offering integrated drug development spanning many different disease areas. So, with such a variety of options to choose from, what aspects should you evaluate when making this important decision?
It goes without saying that quality should be one of the key aspects to consider when comparing potential future CROs. Working with an organisation that has an ingrained culture of quality, where processes are constantly reviewed and improved, and which continuously strives to be the best, will provide you with a foundation for success. Review the company’s track record: a history of consistently successful projects is a good indication that future projects will flourish too.
You’ll also want to select a CRO with experience and expertise in your specific therapeutic area, especially if you’re looking for an outsourcing partner that can efficiently solve problems in real-time. A company that can provide a mix of academic excellence and strong industry experience is ideal. Furthermore, a robust knowledge of regulatory affairs and the delivery of a ready to submit data package will be invaluable and help reach first-in-human.
Before making the final decision, check whether the CRO is able to provide all the services required for your drug development program. Understand what activities are included in each service and whether the company will deliver these in-house or if it will outsource any aspects too. For example, does the CRO’s own scientists have a successful track record of developing treatments in your therapeutic area?
For any relationship to work, good communication is key. The CRO you select will be an extension of your team, and for your development program to run smoothly, everyone needs to be on the same page with regards to expectations. In addition, it must be clear to everyone involved what the strategy is, what the next steps are and what timelines need to be worked to. Make sure you’re working with a dedicated project manager who’s firmly integrated with all of the relevant sub-teams, and who can give you a complete overview of development progress in real-time.
What’s better than meeting, or even beating, deadlines and having milestones reached on time? Delays in development and approval limit lifetime sales for a drug, which is why it is so important to not let timelines get out of control. Using multiple CROs for different aspects of your development program could have a non-linear impact on overall timelines if delays occur. If one CRO is late, you have to wait for the next available slot with your next CRO. Employing the services of a single full-service CRO has the benefit that you won’t need to allow for extra time between companies, meaning any delays should have a much smaller, linear impact.
Selecting the right CRO for your drug development program is not a decision to be made lightly. With so much choice available, selecting the right CRO for your program can be a tough decision, so it’s important to do your research into the qualities that could impact your project. Download our eBook to find out the top five qualities and factors to consider.