Selecting a reliable CRO clinical Research Company is crucial to the success of a clinical trial and pharma companies need to ensure they choose the right CRO Company to monitor and manage a project so it leads to a successful outcome.
The following are some important criteria to consider when evaluating clinical research organization companies:
1. Quality Monitoring and Management
Compliance is one of the keys to a successful clinical trial and high-quality monitoring and management are the most important considerations in choosing a CRO clinical research company.
Certificates in evidence of meeting quality standards should be carefully reviewed before making a final selection.
2. Experience in the Therapeutic Area
Clinical research is a specialised field and only CRO companies experienced in the therapeutic area being investigated should be considered.
The CRO clinical research company should agree to provide a reference list of clients.
Reputable clinical research organization companies should have an experienced executive management team that takes responsibility for the internal operations.
3. CRO Capabilities
While assessing the CRO Company’s capabilities, determine whether they can provide the required services throughout the study.
CRO companies should be able to demonstrate complete transparency of their operating systems. These should be linked together to ensure there is no duplication across activities.
When comparing costs from different CRO companies, the unit costs for line items should be considered and not just the total cost.
A lower-cost bid may not take into consideration all the specifications required for the study and could lead to cost escalations arising from unexpected expenses in the future, which should have been accounted for in the proposal.
A healthy relationship between a CRO company and the site is important to the conduct of a smooth process.
CRO monitors whose site staff are upset can impact on the outcome of a clinical process. Healthy relationships between the monitor and a site is also important for achieving compliance and should be considered by a sponsor.
It’s important to keep in mind that the CRO clinical research company selected is like an extension of a sponsor’s team. Their operations at a site aren’t just important to the outcome of the trial, but also impact on the reputation of the sponsor.