Safety & Tox Guide

Nonclinical safety studies are a critical stage in new drug development. These studies evaluate a drug’s effects on the organism and potential risks, and their results help assess whether to proceed to clinical trials. Selecting a CRO to conduct nonclinical studies is a consequential decision that can influence the success of a development program. This article explains key considerations when choosing a CRO.

Can they comply with stringent regulations?

Regulatory compliance is one of the most important factors. Nonclinical safety studies must meet rigorous standards set by national and regional authorities. Because requirements differ—for example, those of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)—studies must be designed and conducted in accordance with the applicable standards. It is therefore essential to confirm that the CRO is well-versed in these regulations and can execute studies under the latest guidelines.

CROs with strong regulatory capabilities can also support preparation of country-specific application documents and communications with regulators. This enables sponsors to outsource with confidence and may facilitate a smoother approval process later on. In addition, confirm thorough adherence to GxP (e.g., GLP, GCP) and whether the CRO holds certifications that demonstrate compliance with international standards.

Can they keep costs under control?

Cost is another unavoidable consideration when selecting a CRO. Nonclinical studies often span long timeframes, and the associated costs can be significant. However, higher prices do not automatically guarantee higher quality. The priority is to evaluate cost-effectiveness relative to the quality of services provided.

When comparing costs, consider not only base study fees but also add-on charges and optional services to capture the total cost. Verify whether the CRO offers cost-saving options, such as volume discounts for bundling multiple studies or price reductions tied to long-term agreements. CROs that propose flexible payment schedules aligned with study progress can also support sound financial planning.

Can they deliver results quickly?

Timeliness is equally important. Drug development is time-sensitive, and delays in reporting can affect the overall schedule. Select a CRO that can conduct studies efficiently and provide results on a timely basis.

To evaluate timeliness, review the CRO’s lead-time track record and the average duration from study start to final reporting. Also confirm the organization’s ability to respond quickly to unexpected issues during the study. For example, CROs that provide online systems for real-time progress visibility or maintain an emergency response team can generally address issues more rapidly.

Communication speed also matters. The responsiveness to inquiries and the frequency of progress updates and data sharing can materially affect project execution.

List of Non-clinical Safety Studies

To prepare for drug approval applications, comprehensive safety testing is essential. This section explains the key testing items required at each phase, focusing on GLP-compliant studies, which are mandatory for regulatory submissions, as well as pharmacological evaluations and specialized studies.

GLP-compliant toxicity testing

GLP compliant toxicity testing isEnsures data reliability and is essential for transitioning to clinical trials and filing for approvalThis is the foundation. To complete this within a limited budget and schedule, securing slots early, reducing risks through preliminary tests, and understanding the cost structure are essential. Selecting a specialized partner with a track record in PMDA applications and consulting capabilities, who can prevent rework, is key to development success.

Summary

When outsourcing nonclinical safety studies, assess a CRO’s regulatory compliance capability, cost reasonableness, and timeliness in a comprehensive manner. Balancing these factors can improve the likelihood of project success and help keep development on schedule. Ultimately, choosing a partner with whom you can build a reliable working relationship is essential in new drug development.