Selecting a contract research organisation (CRO) to help support your ADME-Tox needs is an important consideration. Examining the drug-drug interaction potential of a lead compound will require a different vetting process than contracting out a 25 compound series for an array of ADME-Tox assessments. But in either situation, there are a few things to consider when evaluating CROs to ensure you’re satisfied during the process and when the data is delivered.
- Quality assurance processes – As a client, you have to be able to trust the data you get is accurate. Firstly it is important to assess if the studies are designed appropriately to meet your objectives and to generate robust data. Are appropriate QC processes in place to ensure that the data collected and reported is precise and accurate? Ask the CRO to present their quality systems before you initiate a study and visit the site to understand their workflow processes and expertise.
- Turnaround time – Turnaround time is dependent on the stage of the project. Clinical stage in vitro drug-drug interaction studies may take several months to complete due to the increased level of reporting and customisation. Within a discovery setting, 10 working days from the receipt of compounds is the generally accepted time for many standard in vitro ADME-Tox assays. However, a well-equipped and automated lab should be able to offer some degree of flexibility and faster turnarounds can often be negotiated especially if regular shipments are received on pre-scheduled agreed dates.
- Expertise – CRO’s harbour a wealth of experience from the numerous client projects on which they work. Organisations which specialise in a particular field can typically assist with study design and data interpretation, and become an integral part of your project team.
- Flexibility – Not every project fits to standard conditions. It’s important to know if a CRO has the ability to adapt an assay to your specifications. In some cases, this could even have the added benefit of generating publishable data.
- Range of services – Choosing an established CRO which offers a wide portfolio of services has significant advantages. Not only does it facilitate contractual agreements and logistics, the collation of data from a single provider is easier and project-related discussions can be more productive if the CRO is aware of all the data being generated.
- Cost – This is obvious. You have a budget. Certain assays or services might have a greater degree of flexibility with respect to price. Many CROs offer volume discounts for standard assays or spend related discounts. Enquiring about pricing bundles might also find you unexpected savings, as some contract research organisations will group similar assays and sell them as a package.
- What you can do to help – Once you’ve decided on a service provider for your in vitro testing, there are a couple easy things you can do the make sure it all runs smoothly.
- Weighing/dispensing and labelling compounds is critical to avoiding delays.
- Use plenty of ice packs or dry ice and robust packaging. Sometimes shippers experience delays. A well-packed sample could make the difference between a timely start and the request to send another batch. Ensure that you complete the shipping paperwork accurately to avoid delays at customs; this is something that your CRO can advise on if you are an inexperienced shipper.
- Providing information on solubility, stability and any analytical challenges before the study starts can reduce delays and can assist in protocol design.
Working with a CRO can be a beneficial experience beyond just getting the data you need. By picking the right contract service provider you can reap the rewards of an experienced scientist at a fraction of the cost of a full-time employee.
Contact us to find out how we compare to your current CRO or stack up next to other ones you’re considering.