It is essential to choose the right preclinical contract research organization (CRO) that understands your research needs and provides you with quality results. Getting conclusive preclinical results with clear data in a timely manner is key to the decision-making process before the transition to clinical drug development.
How to find the best preclinical CRO for your study
The best way to find the right preclinical CRO for your study is to find the best match for your individual study needs. For example, what capabilities and expertise do you need the most from a CRO? Do you want the CRO to conduct the study independently until the dataset is ready, or do you want them to communicate with you regularly throughout the study? Do you need to kickstart your study as soon as possible, or are you only in the initial phases of planning and designing a study?
While there is no one-size-fits-all approach, we can certainly provide tips and tricks on how to find the best preclinical CRO for your research needs. Below are the 5 topics of questions you should ask yourself when you found a relevant CRO and are considering conducting a study with them.
- Capabilities and Expertise
- Technology
- Regulatory Compliance & Quality Assurance
- Expectations and Cultural Fit
- Additional Considerations
Are you in a rush? Don’t worry, you can download the checklist here (Google Sheet)
Capabilities and Expertise
Questions you should ask:
- Does the preclinical CRO have the right capabilities to meet your specific research needs?
- Does the preclinical CRO have experience in your target?
- Does the preclinical CRO have experience in the relevant drug class?
- How many studies has the preclinical CRO conducted for the disease indication?
- Can the preclinical CRO analyze your study design to mitigate potential risks?
- Can the preclinical CRO create and provide IND-enabling reports for submissions?
- Does the preclinical CRO offer you conclusive data with actionable insights?
Technology
Questions you should ask:
- Does the preclinical CRO provide an interactive data platform solution where you can access and export your study data?
- Does the preclinical CRO have an in-house team that develops and manages the data platform, ensuring the cybersecurity?
- Does the preclinical CRO utilize the latest technology to provide accuracy, objectivity and preciseness for your study?
- Does the preclinical CRO offer intelligent solutions for visualizing and quantifying your drug’s effects on the brain and/or other organs?
Regulatory Compliance & Quality Assurance
Questions you should ask:
- Does the preclinical CRO have a track record of conducting research with consistently high standards and regulatory compliance?
- Does the preclinical CRO have an excellent history of audit performance?
- Can the preclinical CRO provide documentation on their compliance with any applicable law and regulation concerning the studies?
- Can the preclinical CRO provide information and documentation on their high cybersecurity standards?
- Does the preclinical CRO use structured and documented training programs for all relevant staff?
Expectations and Cultural Fit
Questions you should ask:
- Does the preclinical CRO provide clear communication on how they plan to execute the study and update you with the study results?
- Does the preclinical CRO provide professional guidance on the study design with clear reasoning and reliable explanations?
- Does the preclinical CRO provide clear communication if they see any potential risks?
- Does the preclinical CRO offer a detailed breakdown of service costs?
- Does the preclinical CRO’s study team consist of highly qualified and experienced scientists within your therapeutic area or indication?
- Does the preclinical CRO provide a dedicated Study Director and Principal Investigator for your study?
- Does the preclinical CRO provide flexibility to tailor to your study according to your needs?
- Does the preclinical CRO’s communication style fit your company’s culture and expectations?
- Can the preclinical CRO offer regular and frequent updates on the study progress, providing on–line access to your study data?
- Does the preclinical CRO offer effective cross– functional communication?
- Can the preclinical CRO provide reference contacts who can verify former successful collaborations?
- Does the preclinical CRO ensure a thorough ethical approach to both its business and research?
- Does the preclinical CRO demonstrate their transparency and honesty as their core value?
- Does the preclinical CRO demonstrate their proactiveness and efficiency as their core value?
Additional Considerations
Questions you should ask:
- Does the preclinical CRO have the animal models ready to be included in your study, meaning that disease induction has already been performed?
- Does the preclinical CRO have publications and other reference data to demonstrate their research capabilities and data visualization and interpretation skills?
Download the checklist and get full access free of charge
If you’d like to download this checklist and get free access to the 32 questions, click here (Google Sheet).
Are you ready to discuss your research needs with a CRO that meets all the requirements above? Simply fill out the form below and wait for our experienced scientist to reach out to you.
