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What Are the Top 7 Considerations When Choosing a Central Lab Partner?
For sponsors and CROs, reducing time-to-market and improving patient access to innovative treatments remain pressing challenges and top priorities. From regulatory hurdles and logistical complexities to patient recruitment and retention, the road to a successful trial across multiple regions and populations is complex, requiring a partner with global reach and expertise.
Working with a global central lab is the best way to meet your trial’s specific needs for resources, expertise, and capabilities. Additionally, a global central lab can help ensure continuity and consistency across your data by providing a repeatable and scalable approach to sample handling and testing, a key to data accuracy when drawing from disparate regions.
Choosing the Right Global Partner
Clinical trial research is no longer confined to a single country or region. In fact, the pharmaceutical and biotechnology industries are experiencing a major shift towards global drug development strategies. The best global central lab partners become indispensable for facilitating seamless sample logistics, standardized testing methodologies, and regulatory compliance across multiple jurisdictions.
In addition, sponsors and CROs will want to look for a global central lab partner that offers comprehensive capabilities, regulatory compliance, scalability, and innovation to effectively support complex worldwide clinical trials.
The 7 Capabilities to Look Out for Include:
1. Access to Geographically Challenged Areas
Global central labs are key to supporting patient diversity, which can help uncover potential drug response differences (an issue in 20% of approved new drugs in a five-year review) and avoid regulatory delays later on. While multi-regional clinical trials can also streamline global approvals, they can be challenging without a central lab partner that can support timely local processing and consistent data collection protocols around the world.
2. Streamlined Logistics and Sample Handling
Operating across multiple locations requires efficient sample collection, transportation, and processing. The right global central lab can coordinate logistics seamlessly, ensuring that samples are handled properly and reach designated laboratories promptly. This reduces delays and minimizes the risk of sample degradation, ensuring the integrity of study data.
3. 24/7 Operations Across Different Time Zones
Central labs with a global presence can operate around the clock, leveraging different time zones to maintain continuous workflow and expedite turnaround times. This flexibility is particularly advantageous for multinational clinical trials that involve multiple sites, countries, and time zones.
4. Standardized Processes and Methodologies
The best partner will adhere to standardized processes and methodologies, ensuring consistency in sample analysis and data interpretation across all study sites. This consistency enhances data quality and reduces variability, making it easier to compare results and draw meaningful conclusions from the study.
5. Compliance with Local and International Regulations
CROs and trial sponsors need to work with a global central lab partner that can ensure compliance with the diverse regulatory requirements found across different regions and countries. Experienced central lab teams that are well-versed in local and international regulations governing clinical trials will ensure that all aspects of sample management, testing, and data management adhere to relevant guidelines and standards.
6. Cost-Effectiveness and Scalability
Leveraging a global central lab enables cost savings for sponsors. Global central lab service providers should be able to scale their operations to accommodate the varying needs and demands of different clinical trials, providing flexibility and cost-effectiveness without compromising quality.
7. Risk Mitigation
Choosing the right global central lab partner can help mitigate geopolitical risks and uncertainties by diversifying operations across multiple regions. This reduces the impact of localized disruptions, such as political instability, natural disasters, or regulatory changes, on study timelines and data integrity. Risk is further mitigated through the lab’s consistency in sampling, transportation and data analysis.
By partnering with a proven global central lab, sponsors and CROs can bypass the logistical complexity associated with coordinating operations across multiple geographic locations and disparate labs. A strong central lab partner will ensure ongoing and detailed communications and implement an information-sharing system to facilitate real-time collaboration among team members across locations. Clinical trial sponsors and CROs may also benefit from choosing a central lab services provider that offers functional service provider solutions that can deliver a skilled and expert workforce to augment internal teams.
At LabConnect, we offer expansive central laboratory services that provide access to more points of service locations than any other central lab. With over 5,000 validated tests accessible in 30 locations across 6 continents, we are the global partner of choice when it comes to accelerating the development of new medicines around the world.