Read the previous article about the preparation and setup phase in clinical trials.

Sample Journey in the Execution Phase at Central Lab – The Most Common Scenario 

There are many possible scenarios for how a sample moves through the Execution Phase, depending on the study design. Below is the most common path, showing how samples are handled from collection at the site to final data reporting. 

1. Sample collection at the site 

Biological samples (e.g., blood, urine) are collected from trial participants in accordance with the study protocol. The sampling sets (tubes, labels, instructions, etc.) are prepared on the site request by Assemble Team and provided in advance by the Logistic Team from the Central Lab. 

2. Preparation and shipment from the site 

After collection, samples are packed following specific shipping instructions, including temperature requirements (e.g. on dry ice). The Logistics Team oversees each step of the shipment process – from the site to the central laboratory – ensuring that no samples are lost, delayed, or compromised.  

3. Sample receipt and registration at the Central Lab 
   Upon arrival at the Central Lab, the Sample Management Team performs quality checks (e.g., data compliance, sample integrity, transport conditions). Each sample is registered and prepared for further analysis. 

4. Laboratory testing in the diagnostic lab 
   Samples are forwarded to the appropriate diagnostic/bioanalytical laboratory for testing, performed according to the study protocol requirements. 

5. Storage of samples & leftovers  

If requested by the client or defined in the study protocol, any remaining sample material after analysis can be transferred back to the Sample Management department for storage under deep-frozen conditions. The team maintains accurate storage records and ensures availability in case retesting is required. Samples can be stored for as long as needed, in line with the protocol and client-specific requirements. 

6. Transfer of results 
   Once testing is completed, the results are reviewed and verified by the Clinical Research Coordinators to confirm compliance with the study protocol and quality standards. 

7. Reporting of results to sites 
   The Clinical Research Coordinators deliver results to the sites – most often through secure web portals or encrypted email. They also manage ongoing communication with site staff to ensure clarity and timely updates. 

Teams responsibilities  

The smooth operation of the Execution Phase in Central Laboratory depends on the collaboration of multiple specialized teams. Each group plays a distinct role in ensuring that clinical trial activities – from sample management to data delivery – are performed efficiently, accurately, and in full compliance with study protocols. 

Project Management Team 

Project Managers oversee all aspects of ongoing project phases, acting as the primary link between the Central Lab, clinical sites, and the sponsor or CRO. Often serving as the single point of contact, they coordinate timelines, monitor project milestones, and ensure that all deliverables remain on track. 

Read more about the role of Project Manager. 

Clinical Research Coordinators 

Clinical Research Coordinators oversee the flow of laboratory data, ensuring that results are delivered promptly to investigational sites through secure web portals or encrypted email. They serve as a key communication link between the laboratory and the sites and work closely with the Data Management Team throughout the study to resolve data discrepancies as part of the daily data reconciliation process. They also ensure that all results align with protocol requirements and meet regulatory standards. 

Assemble and Stock Management Team 

This team is responsible for preparing and dispatching all sampling materials to clinical sites – typically within 10 working days. They manage inventory levels, provide support related to collections sets (kits) documentation, and ensure the consistent availability of tubes and auxiliary supplies throughout the study. 

Logistic Team 

They supervise the shipment processes to sites and performing laboratories making sure that samples and collection sets are delivered on time, under proper conditions, and without damage. The team closely monitors shipping timelines and temperature requirements at every stage, ensuring that all materials arrive under the conditions specified in the protocol.  

Sample Management Team:  

This team manages both the pre-analytical and post-analytical phases of each visit. They receive and inspect incoming samples, register them, checked quality and prepare them for testing. After analysis, if requested by the client or defined in the study protocol, samples can be returned for long-term storage at our deep-frozen facilities, where they are kept under monitored conditions for the duration of the study. If not, the team designs a backup aliquot, and the remaining material is usually disposed of.  

 
Read more about the role of Sample Management Department. 

Data Management Team: 

The Data Management Team plays a vital role in ensuring the success and reliability of clinical trials. They are responsible for the accurate collection, storage, and analysis of study data – safeguarding its integrity, quality, and consistency throughout the trial. 

Compliance & Quality Assurance Team:  

This team ensures that every process across the Central Lab meets the highest regulatory  compliance and internal quality standards. Through regular audits, documentation reviews, and process evaluations, they maintain alignment with Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) guidelines and uphold quality assurance across all project stages. 

Tools and services used in execution phase at Central Lab

Efficient execution of clinical trials relies not only on well-coordinated teams but also on specialized tools and support services. 

CTMLS – Clinical Trial Management Laboratory System 

Recognizing the increasing demands and specific requirements in the field of clinical trials, our Data Management Team has developed a valuable tool for both internal use and site utilization: an in-house developed database for clinical trial projects. The LabOne software offers a range of functionalities, including project management, evidence collection, trial participant and data management, and real-time connectivity with laboratory information systems. 

Additionally, electronic data transfer is conducted according to the specifications set during the contracting phase and outlined in the electronic data transfer agreement, ensuring seamless integration and compliance with established standards. 

In clinical trials, data collected from central labs often represents a significant portion of the overall dataset, with lab results frequently contributing up to 60-70% of the data used in regulatory submissions and analysis. This underscores the importance of rigorous data management and adherence to quality standards to ensure that trial outcomes are based on reliable and precise information. 

Dry Ice shipment 

Medicover MICS also provides its own dry ice solutions, tailored specifically for biosamples that require frozen transport. On request, dry ice replenishment can be arranged directly for sites, helping them maintain proper storage and shipment conditions.  Read more about shipping lab samples in dry ice. 

Looking for a Central Lab Partner? 

to explore how we can support your next clinical trial. 

FAQ – Execution phase at Central Lab

Author: Michał Widak, Senior Clinical Research Coordinator, Sample Management Team Leader. MICS Editorial Team 

In this article, we explore the essential role of laboratory sample management in clinical trials, focusing on processes such as collection, tracking, storage, and logistics. Our specialist provides a structured overview of best practices and common challenges that can impact trial efficiency and data integrity. This article is particularly valuable for CROs and pharma industry professionals responsible for selecting a central laboratory partner, offering insights into how effective sample management can reduce risks, improve compliance, and support the success of clinical research. 

Introduction 

Laboratory sample management, especially in Central Laboratory, is an integral part of clinical trials, ensuring that the samples collected during the study are handled with precision and care. From collection to analysis, every step in the sample journey requires scrupulous attention to detail. For CROs and pharma companies choosing a central laboratory partner, understanding the strengths of a laboratory sample management department is crucial. The right partner can ensure the efficient processing of samples, preserving the integrity of the data and ultimately supporting the success of clinical trials. 

What is Sample Management in clinical trials? 

Sample management in clinical trials refers to the entire process of handling biological samples, such as blood, tissue, and urine, from the point of collection to the point of analysis. The laboratory sample management department is responsible for organizing, tracking, and processing these samples to ensure they are properly handled, stored, and transported in compliance with regulatory requirements and clients’ needs. This department plays a crucial role in ensuring the accuracy and reliability of trial data, impacting the overall success of the clinical study. 

Key Functions of the Laboratory Sample Management Department 

The sample management department performs several key activities to ensure samples are properly handled throughout the clinical trial process. These include: 

• Sample Collection and Receipt: Proper collection and handling of samples from clinical trial sites are essential. The laboratory sample management department ensures that each sample is correctly identified, documented, checked for quality and immediately processed in accordance with the analytical plan for a given study. 

• Tracking and Documentation: Efficient tracking is critical for managing the flow of samples. The department is responsible for maintaining detailed records of sample reception, storage conditions, transportation, and testing. This ensures traceability and accountability at every stage. 

• Storage and Preservation: Each type of sample has specific storage requirements, and maintaining the correct conditions (e.g., temperature control) is essential to preserving sample integrity. The department ensures that samples are stored in appropriate conditions which are monitored continuously. 

• Logistics Coordination: Coordinating the transportation of samples from central laboratory to testing labs is a critical function. The department ensures that samples are shipped under the correct conditions and arrive at their destination on time to avoid delays or errors. 

Challenges Faced by the Sample Management Department 

While the importance of laboratory sample management is clear, there are several challenges that the sample management department must navigate: 

• Sample Loss or Degradation: Mismanagement can lead to sample loss or degradation, which can affect the accuracy of the trial results. This is especially true for sensitive biological samples, which may require special handling or immediate processing. 

• Volume and Complexity: Managing large volumes of samples from multiple clinical trial sites can create logistical challenges. The complexity increases when dealing with various sample types, storage requirements, and regulations across different studies and clients’ needs. 

• Regulatory Compliance: Compliance with local and international regulations is essential in the clinical trials industry. The laboratory sample management department must adhere to stringent guidelines related to sample handling, storage, transportation, and documentation to ensure regulatory compliance. 

Importance of Efficiency and Accuracy in Sample Management 

The efficiency and accuracy of the laboratory sample management department directly impacts the success of the clinical trial. Errors in sample management—such as mislabeling, incorrect storage, or delayed transportation—can compromise the reliability of the trial data. Samples with uncertain quality can lead to erroneous conclusions, affecting both the trial’s results and the final approval process for new treatments or drugs. Therefore, at Medicover Integrated Clinical Services, we maintain a high level of accuracy and operational efficiency as key elements in ensuring the integrity of clinical trials.

Best Practices for Effective Sample Management 

To ensure effective sample management, the department should implement the following best practices: 

• Streamlined Workflows: Optimizing workflows ensures that samples are processed as efficiently as possible, reducing delays and minimizing human error. Clear protocols and Standard Operating Procedures (SOPs) can help streamline tasks such as sample receipt, documentation, and processing. 

• Technology Integration: Using advanced Clinical Trials Laboratory Management System ((CTLMS); e.g., LabOne) and other automated tools can reduce human error, improve traceability, and enhance compliance. These systems help in sample registration, quality check, tracking sample locations, monitoring storage conditions, and ensuring that data is easily accessible for review. 

• Quality Control Procedures: A robust quality control system is essential for maintaining high standards in sample management. Regular checks on sample integrity, storage conditions, and transportation protocols can prevent errors and ensure consistency across all clinical trials. 

Collaboration Between Sample Management and Other Departments 

The success of sample management in clinical trials also depends on close collaboration between the sample management department and other central laboratory departments like Logistic, Study Coordinators, Project Management, Quality Assurance, IT and also lab technicians, researchers, and trial sponsors. Clear and continuous communication is essential for maintaining smooth operations. For example, the sample management team must stay in contact with lab personnel to ensure that samples are processed promptly and under the correct conditions. Likewise, effective communication with trial sponsors ensures that any potential issues are quickly addressed. 

How a Well-Managed Sample Management Department Can Impact Trial Outcomes? 

A well-managed laboratory sample management department directly contributes to the efficiency of clinical trials. By ensuring that samples are handled correctly, processed quickly, and tracked accurately, the department helps to minimize delays and errors, leading to faster, more reliable trial outcomes. This is especially important in time-sensitive studies where the timing of sample analysis can impact the overall trial timeline. Choosing a partner with a strong laboratory sample management department ensures that trial progress remains on track, which can ultimately shorten the time to market for new therapies. 

Conclusion 

Sample management is a critical aspect of clinical trials, playing a pivotal role in ensuring the accuracy and integrity of the trial data. A well-organized sample management department provides essential support for smooth trial execution by tracking, storing, and transporting samples in compliance with regulations and clients’ needs. For CRO/Pharma vendor management and decision-makers, selecting a central laboratory partner with a robust laboratory sample management department is crucial for minimizing errors and delays. Prioritizing efficiency, accuracy, and collaboration will help ensure successful trial outcomes and support the development of new treatments. 

Looking for a reliable central lab partner with expert sample management? 

FAQ: Laboratory Sample Management in Central Labs for Clinical Trials 

In this article, we focus on laboratory sample journey and management – how the material is collected, placed in the appropriate packaging, delivered to the right location, and within the set time frames. We will begin by explaining the basics and fundamentals of the process, outlining the each laboratory sample journey undergoes to add value to every clinical trial.

The process of laboratory sample journey in clinical trials

Before delving into the laboratory sample journey , it is important to understand how the trial setup process works, which documents are essential, and the roles of the Sponsor, CRO, and Central Lab. The setup phase is a critical stage of the study. When done properly, it ensures the laboratory samples are correctly prepared, handled, and their journey is safer and more efficient.

Setup of the trial at Central Laboratory 

The first and most important document at the start of the study setup is the Study Protocol. It is a comprehensive document, prepared by the Sponsor or CRO, that outlines the objectives, design, methodology, statistical considerations, and organization of a clinical trial. When the study begins, the Study Protocol is provided to the Central Lab, which conducts a thorough review to understand the laboratory requirements specified for the trial. This includes identifying the required tests and their specific parameters. The laboratory sample journey has not started yet.

Based on the Protocol and the signed budget agreement, an Analytical Plan is developed. This document serves as the foundation for all laboratory-related activities within the study. It is customized to the study’s specific requirements and includes detailed information such as: 

• The list of required tests and their timelines. 
• The number and structure of visits. 
• The design and composition of sample collection sets 
• The data structure and database configuration for result tracking and reporting. 

The Analytical Plan ensures that all laboratory processes are aligned with the Protocol and that sample collection kits are assembled appropriately.

How is the design of each sample collection established? 

The design of each collection set is established based on the Analytical Plan (AP), which is approved by the Sponsor. This process takes into account the specific tests required for the study, allowing the selection of appropriate tubes and materials for sample collection. Key factors considered include the type of biological material to be collected, packaging materials, transport temperature, and transportation conditions, ensuring all requirements are known and addressed during the design phase. 

The following process is based on the experience and services currently provided by Medicover Integrated Clinical Services. These practices have been tested and approved by our global partners, ensuring reliability and compliance with the highest industry standards. 

The Assembly Team produces custom collection kits tailored to the specific needs of each clinical trial. These kits are designed to minimize pre-analytical errors and maintain sample integrity throughout transportation. Key features of the collection setup include: 

• Custom-built to meet protocol and visit requirements 
• Pre-formatted air waybills (AWBs) to reduce paperwork at the collection site. 
• Customized laboratory requisition forms 
• Pre-labeled collection tubes, to minimize labeling errors 
• Comprehensive specimen collection and handling instructions provided in a detailed brochure. 

Once the kits are assembled, logistics processes are designed to include secure transportation and storage. This ensures that the kits are delivered to clinical trial sites worldwide in a timely and controlled manner. 

Our collection sets stand out for the ease of sample collection, prioritizing patient comfort and maintaining sample integrity. Depending on study-specific requirements, there are two types of kits: 

1 – Routine Kits: These are designed for standard sample collection and ensure accuracy and ease of use for healthcare professionals. 

2 – Specialized Kits: These are developed for studies requiring advanced efficacy parameter testing, such as pharmacokinetics (PK), anti-drug antibodies (ADA), and biomarker analysis. 

Contact us today to get a quote for your clinical research. We response in 24 hours.  

Both types of kits include essential components: 

• Sample Containers: Carefully selected to suit different sample types and meet safety and regulatory standards. 
• Labels and Barcoding: Unique barcodes are applied to ensure accurate laboratory sample journey traceability and data precision. 
• Detailed Instructions: Clear and concise guidelines for healthcare professionals or patients on proper sample collection and handling. 
• Safety Supplies: Necessary safety materials, such as gloves, disposable gowns, and biohazard bags, are provided. Kits comply with IATA regulations, including triple-layered protection and appropriate biological category markings on external packaging. 

Specialized Kits for Efficacy Parameters, like PK, ADA, Biomarkers, etc., for studies requiring specialized efficacy parameter testing, we go beyond standard laboratory sample journey that meet the highest industry standards. These kits may include: 

• Customized Sample Collection Tubes – we design tubes with specific additives or coatings tailored to the stability and requirements of the analyte, such as PK markers or ADA detection. 
• Anticoagulants – for blood collection, we provide the appropriate anticoagulants to prevent clotting and maintain sample integrity. 
• Preservation Solutions – Some biomarkers may require preservation solutions to ensure sample stability during transportation. 
• Unique Sample Preparation Instructions – Specialized instructions are included to guide sample preparation for advanced testing methods, ensuring optimal results. 
• Temperature-Controlled Components – Kits for temperature-sensitive biomarkers or PK samples may include temperature-controlled compartments or cool packs for sample storage and transport. There is also an availability for ambient, refrigerated, or frozen shipping, using dry ice solutions or validated thermo boxes. You can learn more here about shipping lab samples with dry ice. 

The benefits of dry ice for shipping lab samples 

Different types of kits established at this stage will be prepared to be study-specific, site-specific, and visit-specific, greatly assisting site personnel in easily selecting the appropriate collection set for each patient visit. 

Did you know that Study Setup involves more than just preparing the lab manual and assembling the collection sets? It also includes designing a database to capture all required data as agreed with the Sponsor. The database is structured to facilitate the accurate, efficient, and Protocol-compliant reporting of results to investigators and clients. 

The kit (collection set) must meet all necessary specifications to maintain the stability of the samples from the point of collection to the time of analysis. This ensures sample integrity and reliable test results. 

How is a study-specific Lab Manual prepared? 

Following the completion of the Analytical Plan, a Lab Manual is developed to include detailed instructions on sample collection, handling, packaging, and shipment. The manual is designed specifically for the study and contains information solely related to the samples required for that particular trial. Its content is prepared based on the recommendations provided by the laboratory assigned to analyze the samples. 

The process of laboratory sample journey

Understanding the study setup and the assembly of the collection kit provides a foundation for presenting the laboratory’s sample.

Key components to ensure successful sample journey 

The role of training 

Proper training is the foundation of an effective sample journey. This includes not only equipping clinical site personnel with the knowledge and skills required to handle, store, and transport samples correctly but also ensuring that internal teams are thoroughly trained. 

Clinical site staff should be well-versed in sample collection protocols, labeling requirements, and shipment preparation. Providing clear and accessible training materials, step-by-step guides, and ongoing support can significantly reduce pre-analytical errors. 

Equally important is the training of internal teams, including logistics coordinators and laboratory staff. By fostering expertise within Medicover Integrated Clinical Services, the company ensures that every team member aligns with the highest standards of quality, precision, and regulatory compliance. MICS personnel are also trained in study-specific procedures by the responsible project manager before each study begins. This continuous education and regular workshops help maintain this level of excellence. 

Availability of resources 

Ensuring the availability of appropriate resources is a critical aspect of successful sample management. This includes having dedicated personnel and access to specialized tools and infrastructure. 

• Dedicated Personnel: A team of logistics coordinators specialized in clinical trials is essential. These professionals are not only skilled in managing the complexities of global sample transportation but also committed to going the extra mile to support clinical sites. Their willingness to address site-specific challenges, offer detailed guidance, and provide tailored solutions fosters trust and efficiency. 
• Comprehensive Resources: Access to appropriate storage solutions, temperature-controlled transportation, and customizable sample collection kits ensures that samples remain intact throughout their journey. Having the right tools in place minimizes delays, mitigates risks, and upholds sample integrity. 

Sample Tracking and Monitoring System 

Effective sample tracking and monitoring is vital for maintaining transparency and control throughout the sample lifecycle. Based on Medicover Integrated Clinical Services’ expertise, the proprietary LabOne Clinical Trial Laboratory Management System serves as a state-of-the-art solution to streamline sample management. 

Sample Kits Monitoring include expiration date, study sites stock status, collection kits and laboratory supplies re-supply.

LabOne allows sponsors and researchers to define trial-specific parameters, track samples in real time, and access laboratory results whenever and wherever needed. Key features of the system include: 

• Real-time lab-result data with 24/7 access. 
• Extensive reporting modules for customized insights. 
• Color-coded results for intuitive interpretation. 
• Compliance with 21 CFR Part 11 for electronic records. 
• Fully customizable reporting and dashboards. 
• Intuitive management of samples, kits, and inventory. 
• High emphasis on data security and privacy. 
• Quality control and assurance modules. 
• Built-in communication and collaboration tools for study management. 

LabOne simplifies sample management by offering centralized barcode labeling, sample tracking, and chain-of-custody management. Its robust design ensures complete visibility and traceability of all sample-related data. 

Additionally, Kit and Inventory Management features enable tracking of kit production, distribution, and consumption. This ensures sites are equipped with the necessary supplies, reducing delays and preventing errors. 

Conclusion

In conclusion, the laboratory sample journey is a critical component in clinical trials, encompassing precise processes from sample collection and handling to analysis and data reporting. Each step is designed to maintain sample integrity and ensure accurate, reliable results, which are essential for the success of clinical research. By optimizing this laboratory sample journey, Sponsors can achieve greater confidence in the quality of their data, supporting informed decision-making and the overall success of their trials.

FAQ: Understanding the Laboratory Sample Journey 

References

Author: MICS Editorial Team