Challenges in Clinical Data Management


A clinical research laboratory provides a wide range of clinical safety and efficacy testing which involves several steps starting with data collection from patients and their corresponding samples, analyzing test results to generating the reports. Managing all these information manually, using spreadsheets and lab-notebooks is error-prone. Furthermore, the technology advancements in the healthcare industry have resulted in generation of voluminous data.

Operational Challenges

Clinical research laboratories encounter a host of operational challenges, day in and day out.

Data: Managing massive amounts of data generated by the clinical labs, is critical and painstaking.

Centralizing Data: With the globalization of the clinical industry, an increase in multi-site studies has warranted a centralized database of patient and product data, which is secure and seamlessly accessible round the clock.

Lab Compliance: A secure chain of custody, multiple levels of approvals, complete audit trails, data integrity and confidentiality along with 21CFR Part 11 compliance are a must.

Real Time Tracking: Lab managers are required to be updated on the status of different operations within the various departments, which is impossible without a web based, centrally hosted system that can be accessed 24×7.

In the recent years, lab automation is becoming more and more imperative, especially for the clinical industry for the following reasons:

  • An increased and continuous inflow of data from clinical and medical laboratories across the globe.
  • Technology expansion in the areas of proteomics and genomics, in addition to the drive towards personalized medicine and rare disease treatment.
  • Adoption of big data and growing demand for better data storage and management solutions.
  • Emerging markets such as India, China and Eastern Europe, pressing hard for automation and increased need for regulatory compliance.