News / Press Release

6 Signs You Need a New CRO for Your Preclinical Research

April 25, 2018

You have goals for every project, and your CRO should be as committed to those goals as you are. But if things take too long to get done, don’t rush to flip the kill switch on your project. It might be time to switch CROs instead. Learn to spot these six signs your preclinical work needs a new CRO:

1. You’re fed up with all the change orders.

Research is dynamic—and often, you don’t know how it’s going to go until you get the study started. Adjustments in dose, schedule or collections are par for the course. But if your requests for mid-study tweaks are met with a stern requirement for a change order on every single change, it’s time to change the partner, not the order.

2. You can’t find rare disease models to support your work.

Mainstream models only take you so far, especially in rare disease research. If you need access to molecularly defined models that recapitulate tumor-promoting cancer drivers—but find that your CRO can’t deliver—it’s time you start working with someone who can find exactly what you need, when you need it. Because in science, “close enough” won’t cut it.

3. Progress has stalled, and you don’t know why.

What’s with all the timeline delays, and why aren’t you kept in the loop of status updates? Or worse, why are you on a waitlist to get started? Your work is too precious to stall out—so say goodbye to the dreaded waiting period and work with a partner who will get you started on day 1, and keep you updated all the days after.

4. You’ve got plenty of models, but are they clinically relevant?

You need models, and your CRO provides them—but are they validated in relevant clinical settings? Ask your current partner for their thoughts on clinical strategy and what models support that approach, and if they can’t provide that level of insight, it might be time to ask their competitors the same.

5. You need more meaningful data from biomarker assays.

When it comes to biomarker assays, chances are you’ll have a ton of options. But which ones provide the biggest impact with relevant data? If your CRO isn’t giving that expert counsel, or if your questions are met with doubt, it’s time to find someone versed in all things assay—from multiplex cytokine analyses and tumor immune cell infiltrate profiling to quantitation of the effect of therapy on the microbiome.

6. You’re left to your own devices for model selection.

Your drug’s mechanism of action (MOA) is unique, and you need the right models based on that MOA. But if your CRO isn’t providing MOA-based filters to help you find the right models for your project—and following that search up with targeted interrogation—it can be like finding a needle in a haystack.

Sound like you? If you’re frustrated with the progress, don’t kill the project—find a new CRO. With TD2, we’ll help you fast-track your research with an integrative and diverse suite of preclinical tools, from more than 300 tumor models that align with a well-defined clinical and regulatory strategy (in vivo, in vitro and specialized models) to bioanalytical and ADME support. And when it comes time for execution, we’ll help you launch a clinical study with a focus on early detection of clinical benefit.

Contact us to get your preclinical plan started today!

About Translational Drug Development (TD2)

TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

About TD2

TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

Contact
Tara Franks
602-358-8322
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