4 Top Considerations for CROs when Choosing a Central Lab Partner
Today, there are more than 482,000 registered clinical studies globally, 45,000 more than 2022 and over 100,000 more than 2021. During this same period, the advancements of Phase II and Phase III clinical research studies have increased the volume and complexity of data that needs to be collected and analyzed. Contract Research Organizations (CROs) play a significant role in ensuring the success of drug development through managing these clinical trials, often partnering with global central labs. It’s advantageous for CROs when the central lab has a proven track record of supporting successful trials and can be flexible and step in when a trial requires rescuing.
The Evolving Partnership of CROs and Central Lab Service Providers
Much like how CROs facilitate drug development for sponsors by utilizing their expertise in clinical trial management, central labs provide specialized services for the end-to-end management of lab samples. Partnerships between these two types of organizations are evolving to meet the growing complexities and demands of modern clinical trials.
Utilizing a trusted and experienced central lab to standardize sample collection and manage data can simplify processes and ultimately lead to enhanced efficiency, reduced costs, and improved trial outcomes. Effective communication between a CRO and its central lab partner ensures that any issues can be quickly addressed, minimizing delays and maintaining the timeline of the trial.
4 Top Considerations for CROs When Choosing a Central Lab Partner
Selecting the right central lab partner is critical for a CRO as the central lab is responsible for processing and analyzing the biological samples collected during its clinical trials. Some key considerations for a CRO choosing a central lab services provider include:
1. Accreditation and Compliance
The right central lab partners are typically accredited and comply with regulatory standards, such as Good Clinical Laboratory Practice. This compliance ensures that the data generated is of high quality and meets regulatory requirements.
2. Global Capabilities
CROs often conduct clinical trials across multiple sites and even in different countries. This makes it important to find a central lab with a global reach that can provide standardization of sample collection by reducing variability and improving the quality of the data collected.
Additionally, CROs need to ensure their central lab partner offers real-time tracking and reporting of these samples and test results to enable timely insights and informed decision-making. This level of data management enhances the operational efficiency of clinical trials and contributes to the overall success and reliability of the study.
3. Technological Capabilities
Based on the amount of data flowing in today’s clinical trials, only central labs that possess modern and efficient technologies for sample analysis, data management, and reporting should be considered. It is essential that the chosen central lab has streamlined processes and can repeatedly deliver reliable results. This is crucial for CROs as they need to draw meaningful conclusions about the safety and efficacy of investigational products.
4. Experience and Expertise
Central labs often specialize in specific therapeutic areas. A CRO can benefit from partnering with a central lab that has expertise in the disease areas relevant to their clinical trials, providing valuable insights and contributing to the overall success of the study. In addition, a central lab that also provides functional service provider solutions can deliver valuable expertise and hands-on experience if needed.
The Growing Complexity of Clinical Trials Requires Strong CRO – Central Lab Partnerships
Today, an average study encompasses a staggering 20 endpoints and 263 procedures per patient, resulting in millions of data points per study. This represents a threefold increase in data collection compared to trials conducted just a decade ago. This complexity, along with the efficiencies that CROs can bring, has led to nearly 75% of all clinical trials being overseen by CROs.
As trusted partners of sponsor companies in the pharmaceutical, biotechnology, and medical device industries, CROs are not only conducting clinical trials and research studies – they are also responsible for dealing with this increase in data. This same trusted partnership must exist between the CRO and its central lab services provider. By carefully choosing the right partner, CROs can streamline their clinical trial process and ensure the best possible results for their clients.