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Bioanalytical labs play a crucial role in drug development, providing essential data to answer fundamental questions like “Does it work?” and “Is it safe?” The speed at which scientists can make informed decisions directly impacts the pace of bringing new drugs to market. To meet this challenge, labs are turning to digital solutions that streamline operations and improve data quality.

Unlocking the Power of Data

One of the key assets in modern bioanalytical labs is data. Smart data management can save time, reduce waste, and provide reliable answers quickly. However, in many labs, data is scattered across various systems, including paper notebooks, and spreadsheets. This fragmented approach makes it challenging to leverage data efficiently, leading to missed opportunities and inefficiencies.

With the rise of connected instruments and advanced analytical instruments like ELNs, LIMSs, labs can now integrate their data into a central backbone. This integration allows for streamlined operations, reduced human errors, and improved data accessibility. By centralizing data, labs can create user-friendly reports, and workflows, enabling scientists to make faster, more informed decision

Power of ELN, LIMS and LES for Bioanalysis

The digital transformation of bioanalytical labs is greatly facilitated by the use of Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and Laboratory Execution Systems (LES). These systems play crucial roles in streamlining operations, improving data quality, and enhancing decision-making processes.

LIMS (Laboratory Information Management Systems):

LIMS are central to the implementation of a digital strategy in bioanalytical labs. They provide a structured framework for managing sample information throughout its lifecycle. By tracking sample details from login to disposition, LIMS ensure that data is captured accurately and consistently. This centralized approach to data management improves data integrity and accessibility, enabling scientists to make informed decisions more efficiently.

LIMS play a key role in integrating data from various sources, such as instruments, assays, and experiments. By providing a unified platform for data storage and management, LIMS enable labs to streamline operations and reduce manual errors. This integration also facilitates compliance with regulatory requirements, as data can be easily audited and traced back to its source.

Overall, LIMS contribute significantly to the efficiency and effectiveness of bioanalytical labs, enabling them to leverage data more effectively and make informed decisions.

ELN (Electronic Lab Notebooks):

ELNs are another essential tool in the digital transformation of bioanalytical labs. They provide a digital platform for recording and managing experimental data, replacing traditional paper lab notebooks. ELNs offer several advantages over paper notebooks, including the ability to standardize workflows, automate data entry, and facilitate collaboration among scientists.

One of the key benefits of ELNs is their ability to standardize experimental workflows. By providing templates for recording experimental details, ELNs ensure that data is captured consistently and accurately. This standardization not only improves data quality but also makes it easier to search and analyze data.

ELNs also facilitate collaboration among scientists by providing a central platform for sharing and accessing experimental data. This collaborative approach to data management enables scientists to work more efficiently and effectively, leading to faster decision-making and better outcomes.

LES (Laboratory Execution Systems):

LES are specialized systems designed to automate and enforce procedural steps in the laboratory. In the context of bioanalytical labs, LES play a crucial role in ensuring that experiments are conducted consistently and according to standard operating procedures (SOPs).

One of the key advantages of LES is their ability to enforce procedural execution during testing. By encapsulating SOPs into software, LES ensure that each step of the testing process is recorded and completed before moving on to the next step. This not only improves data quality but also reduces the risk of errors and deviations from protocol.

LES also facilitate real-time monitoring of experiments, allowing scientists to make informed decisions based on up-to-date data. This real-time feedback loop enables labs to respond quickly to changing conditions and optimize experimental workflows for better results

Refining Bioanalytical Labs: Unifying Digital Solutions for Efficiency, Quality, and Innovation

1. Deliver a Platform-Based yet Personalized Laboratory Experience
While personalization of laboratory technologies can be beneficial in the short term, it often leads to information silos and challenges in information exchange. A platform-based approach, on the other hand, allows labs to leverage integrated modules aligned with standard enterprise-wide R&D terminologies and capabilities. This approach, facilitated by tools like LIMS and ELNs, enables better-quality study data generation and enhances collaboration among researchers. By adopting harmonized approaches across sites, labs can achieve enhanced visibility, real-time tracking of experiment statuses, and improved cross-experimental insights.

2. Leverage Digital Lab Tools to Unlock Operational Efficiency & Cost Savings
Digital lab technologies such as LIMS, ELNs, and quality management systems offer significant operational efficiencies and cost-saving opportunities. By retiring legacy systems, eliminating redundant data entry, and building audit trails, labs can streamline workflows, ensure data accuracy, and enhance compliance with regulatory requirements. Additionally, these technologies reduce employee time spent on manual tasks and enable real-time tracking of project workloads, leading to substantial time savings per employee.

3. Drive Enhanced Data Reproducibility & Data Analysis to Create Commercial Value
Data reproducibility is a critical challenge in bioanalytical labs, leading to wasted time, decreased resources, and lower scientific output. Digital platforms that enhance data quality and increase statistical power can address this challenge. By standardizing higher-quality data, labs can increase reproducibility and improve experimental performance. Furthermore, leveraging data analytics tools can help labs extract additional value from their data, accelerating the discovery of new indications and molecules.

Veeda’s Integration of LIMS, ELN, and LES Solutions

Veeda’s Bioanalysis solution integrates Laboratory Information Management System (LIMS), Electronic Laboratory Notebook (ELN), and Laboratory Execution System (LES) functionalities to optimize our bioanalytical lab operations. This integrated approach for bioanalytical studies by providing advanced data management, analysis, and automation tools in a single, cohesive system.

LIMS centralizes sample tracking and data management, ensuring traceability and compliance with regulatory standards. Meanwhile, ELN digitizes experimental data, improving collaboration and reducing manual errors. The LES further enhances our workflows by automating processes and enforcing SOPs, ensuring consistency and quality in our operations. This integration enhances our bioanalytical procedures into efficient, reliable testing methods, where we leveraging connected instruments and intelligent data management capabilities to consistently improve our deliverable outcomes.

Reference Articles:

Disease Overview :

Global Scenario :

In developed nations, the prevalence of Chronic Myeloid Leukaemia (CML) is primarily concentrated among the elderly population, typically aged 60 and above. In contrast, in developing nations, the diagnosis of the disease occurs approximately ten years earlier, impacting individuals in their 50. It is the most common type of blood cancer.

Indian Scenario :

Chronic Myeloid Leukaemia (CML) is a clonal myeloproliferative disorder of a pluripotent stem cell. CML is the commonest adult leukaemia in India and the annual incidence ranges from 0.8– 2.2/100,000 population in males and 0.6– 1.6/100,000 population in females in India.

Out of the 250 CML Trials in active stage, 123 CML Trials worldwide are Phase II trials. 38 CML Trials are exclusively industry funded or are in collaboration with academia and small biopharmaceutical companies.

Why there is need to conduct CML Trials?

CML is the world’s first cancer with specific genotype knowledge, which led to a rationally therapeutic schedule. Imatinib, a tyrosine kinase inhibitor (TKI), was approved by the FDA to treat CML in 2001. The discovery of the TKI-based treatment, changed the CML disease status from a lethal disease to a chronic disease, especially for patients in the chronic phase. There has been an apparent improvement in the survival of CML patients in high-income countries like the United States, France, and Japan. The disease burden of CML distinctly varies in different countries due to diverse opportunities for early-stage screening, novel drugs and medical resources.

Prevailing trends in CML Clinical Trials

Targeted Therapies :

The development of targeted therapies, such as tyrosine kinase inhibitors (TKIs), has been a significant trend in CML clinical trials. TKIs, such as Imatinib, Dasatinib, and Nilotinib, have revolutionized the treatment of CML by specifically targeting the abnormal BCR-ABL protein responsible for the disease.

Treatment-Free Remission (TFR) :

TFR is a growing area of interest in CML clinical trials. It focuses on the possibility of discontinuing TKI treatment in patients who achieve deep molecular responses, aiming to maintain disease control without the need for ongoing therapy.

Combination Therapies :

Investigating the effectiveness of combining different TKIs or combining TKIs with other agents is an ongoing trend in CML clinical trials. Combinations may enhance treatment response, overcome drug resistance, and improve long-term outcomes for patients.

History of Targeted Therapy for CML Trials


Key Challenges and Considerations: Operational & Clinical

The challenges in CML clinical trials are based on the four phases as mentioned below:

  • Chronic Phase
  • Accelerated Phase
  • Accelerated Phase with Patients with NO prior treatment
  • Accelerated Phase with Patients with prior treatment

CML clinical trials across different phases present obstacles for CROs in their operational and clinical activities. These challenges include communication and coordination with sponsors, complex protocols, site monitoring difficulties, patient population identification, geriatric research, study cost management, staff training, and utilization of technology-enabled platforms.

*Below is the chart that shows the impact of these above mentioned challenges with respect to CML Phases for a CRO:

*3/4 of the graph is blue: classified as a major impact, 1/4 of the graph is blue: classified as minor impact, 1/2 of the graph is blue: classified as neutral

Veeda Oncology

In conclusion, CML clinical trials have witnessed significant progress, aided by the expertise of Indian CROs. With our proficiency in managing protocol complexities, addressing the unique requirements of the geriatric population, and optimizing costs, Veeda stands ready to accelerate your upcoming CML trial. We remain dedicated to offering exceptional support to sponsors engaged in CML research. By leveraging our extensive knowledge, sponsors can expect a seamless trial experience, adherence to regulatory requirements, and the generation of robust data. Contact us today to know more about Veeda’s CML trial services.