As COVID-19 tormented many and left others dazed, the number of clinical trials dramatically increased from 2000 onwards. Another change is that quality assurance regulations have become tighter. Clinical database management systems tools have become more necessary for enhancing data quality, which is a key component to the success of clinical trials.

The number of clinical trials in the US in 2022 were over 52,500. The FDA clamped down on data quality by imposing stricter regulations. Earlier, pen and spreadsheet data collection was sufficient, but now electronic data storage via a clinical data management system (CDMS) is best suited to ensure you match their expectations and comply with the latest standards.

Why CDMS is the best option

Key reasons to manage clinical data through a CDMS:

Ensuring satisfactory outcomes from clinical research and compliant submissions.

Control over data entry, transmission, and storage

Checking to verify that data quality is top quality and reliable.

Fast-tracking the time-to-market for a drug.

Reduced drug development time enabling enhanced patient experiences and outcomes.

As technology develops faster it necessitates everyone to move forward and stick with the times. Digital documents are a step in the right direction. No more hand scribbled notes or ineligible writing on important documents! Sharing critical data at the speed of sound and real-time updates to information mean a lot when lives are at stake.

Clinical data management services will ensure consistent automated data collection which prevents user bias or other variables that can manipulate outcomes. It also means decreased operations costs for both IT and the business

Ensure successful submissions

The demand for clinical database management systems has grown as the need to standardize data inputs and find replacements for manual ways of working with electronic systems is vital. Regulatory agencies like the FDA, Pharmaceuticals and Medical Devices Agency (PMDA), European Medicines Agency (EMA), and others are adopting integrated electronic systems. This means that submission formats are becoming standardized to match the requirements of submission review platforms and systems.

Clinical database management systems (CDMS) assists in building a foundation for errorless data collection and collation at a high level. The benefits are faster drug discovery and speedier time-to-market. This is the reason organizations should implement this technology to meet rapidly advancing technological and business needs while ensuring compliance with standards-based clinical entities.

Key takeaways

Through enterprise-wide, centralized clinical database management platforms, you can govern and orchestrate the data management and analysis process, which reduces costs while boosting process efficiency, submission quality, and conformity.