Clinical laboratories are an integral component of patient care and an increasing part of overall healthcare costs. Not only are “big ticket” tests like MRI, CT scans or EKGs performed here; less well-known but equally vital “little ticket” labs contribute too.
Central laboratory services play an invaluable role in clinical trials, from translating laboratory discoveries into real-life treatments at patient bedsides.
Cost-Effectiveness
Although modern medicine has seen immense advances, clinical trials remain an integral component of therapeutic treatments and lifesaving therapies worldwide. Although difficult to quantify the cost associated with these trials, sponsors should approach clinical diagnostic testing with budget in mind.
Central Laboratory Services can help reduce costs by serving as a single hub for centralized, standard lab testing. This allows for more efficient data analysis which in turn leads to cost savings. Furthermore, central labs offer more global perspectives to specimen collection and testing processes, making them better placed to detect any issues before initiating trials.
The central lab concept emerged during the mid-1980s in response to evolving trends and needs in clinical trials. Prior to that time, most diagnostic testing for clinical trials was conducted locally at local laboratories. At that time, patient safety was prioritized over efficacy evaluations in laboratory evaluations.
Central Laboratories Have Been Essential As the Pharmaceutical Industry Has Grown | Innovative Therapeutics Ongoing Research/Target Development/Beneficial To Society In this era of rapid pharmaceutical industry growth and rising demand for new therapies, central laboratories have been essential. By streamlining diagnostic testing by creating a central lab network offering consistent procedures and quality control measures across trial sites; central labs also consolidated test results into one database which ensured consistency and accuracy throughout.
Central laboratories can also offer the specialized tests necessary for specific studies, including immunoassay, flow cytometry, anatomic pathology, genetics or biomarkers testing. Many central labs employ a staff of scientists and technicians that specialize in these services onsite – this saves both the trial sponsor and site both time and money as it eliminates sending samples out elsewhere for testing.
Sending samples directly to a central lab can save money by cutting shipping and storage expenses, and also decrease errors due to less stops along its chain of custody.
Convenience
Central laboratories play a central role in clinical trials by handling much of the laboratory testing required for trials. They analyze samples and report back the results directly to trial sites or sponsors; their centralized nature enables more efficient and accurate reporting while upholding high standards of quality. Central labs also have access to various technologies and expertise needed for conducting various types of tests including immunoassay, flow cytometry, anatomic pathology genetics biomarkers as well as others.
Central laboratories arose out of a need to find an organized, rigorous way of collecting and consolidating test results from multiple trial sites. Local labs typically provide most laboratory services; however, central laboratories offer greater economies of scale and more comprehensive services, including being able to process large volumes of samples faster.
Central labs are responsible for ensuring global data is consistent and compliant with regulatory requirements, making their role increasingly essential as more clinical trials take place globally and require consolidated data collection – this is especially relevant when multi-center trials require different testing requirements at each site.
Modern central laboratories serve an integral purpose: they ensure global laboratories that are coordinated via identical instrumentation and operating procedures that adhere to universal standards of practice, thus guaranteeing consistent and reliable delivery of results to clinical trial sponsors.
Central labs will continue to prioritize providing consistent and timely delivery of results while adapting their offerings to meet industry-wide demands, with an increasing emphasis on providing high-quality genomic data to facilitate precision medicine and targeted therapy development.
As our globalized world becomes ever more interdependent, clinical trial testing must become more efficient. Central laboratories play an integral role in this process and offer many advantages to both trial sponsors and CRO study teams.
Transparency
Clinical trials are an integral component of drug development. They allow pharmaceutical companies to test new medications, assess how effectively they work and ensure that drugs are safe before reaching patients. Clinical trials allow researchers to gain an in-depth knowledge of how drugs interact with different systems within the body and what their impact is at the molecular level. Furthermore, regulatory bodies require all drugs to undergo extensive clinical testing prior to being approved for sale on the market. Utilizing central laboratory services during clinical trials enables researchers to attain accurate and reliable results. Because these labs offer such an expansive variety of capabilities – performing lab assessments and creating test reports; as well as offering courier services to deliver sample collection kits or biosamples between medical institutions for testing purposes.
Selecting the ideal central laboratory service provider is key to the success of clinical studies, with 61% of principal investigators saying their choice had an effect on their willingness to participate in future trials1.
Central laboratories should go further than offering consistent and reliable results by being transparent with their pricing structure and end-to-end visibility of project tasks, so sponsors can make informed decisions about costs. They may even implement an automated forecasting system for kit, reagent, instrumentation, and staffing needs.
Central lab transparency also involves making sure all samples are processed consistently regardless of where they come from, helping reduce bias and ensure consistency among sites. Furthermore, having access to a central laboratory allows researchers to more readily compare results between clinical trials regardless of sample location.
Final consideration is flexibility for clinical trial requirements. Drug development processes can often take years; during that time there can be changes to regulatory environments or unexpected challenges that must be met quickly for compliance to continue smoothly. A central lab that can quickly adapt to these challenges will meet sponsor expectations while remaining compliant with all regulations.
Patient-Centricity
Central labs have always played an essential role in helping sponsors meet trial milestones and deliver results. With trials now taking place around the globe, laboratories must adapt by instituting rigorous quality control measures as well as working closely with local partners to comply with country-specific regulations.
Central laboratory companies typically offer more specialized testing services that may be difficult to come by at local testing locations. Furthermore, central labs are better able to handle high volumes of samples more efficiently than individual local sites – leading to faster turnaround times for sponsors as well as saving them money by saving reagents and equipment expenses as well as decreasing waste produced from running tests at multiple sites.
Central laboratories are becoming more involved in developing diagnostic tools that can identify therapeutic targets. Their goal is to create therapies with lower doses and fewer side effects for improved healthcare in the future, and many central labs support this patient-centric approach as part of healthcare innovation.
Life sciences companies’ focus on patient centricity has altered how they relate to both patients and stakeholders, leading to greater emphasis on engaging patients and caregivers as well as value-based decision-making based on a number of inputs such as cost of drugs or procedures and impact on patient outcomes. Central laboratories can help make this process smoother by providing clear evidence regarding treatment costs.
As our world becomes more interconnected and patient-oriented, life science companies must engage with patients openly and sustainably. This means including them in the design of clinical studies and supporting them as they make important health choices. Global Central Laboratory Services plays an integral role here by offering services tailored specifically for each patient while adhering to strict protocol so as to enable effective decision-making that ultimately benefits lives around the globe.