Clinical Data Management Systems: Three Benefits in the Clinical Study Process
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Since 2000, the number of clinical trials conducted each year has increased dramatically, and quality assurance regulations have become much stricter. As a result, clinical data management systems have become necessary tools for ensuring the highest level of data quality – a key component of clinical trial success.
The Importance of CDMS in Clinical Trial Management
From 2000 – 2009, the average volume of clinical trials increased by 53.95% per year and 14.7% between 2010 and 2019. There had been 32,340 new trials as of November 17, 2020. The annual spending for clinical data services grows as the number of clinical trials increases. Clinical trial costs totaled $46.8 billion globally in 2019.
Also, regulatory bodies like the FDA are enforcing extremely strict regulations to ensure data quality. Whereas pen-and-spreadsheet data collection was once acceptable, electronic data storage via a CDMS is now ideal for ensuring submitted data complies with the latest standards.
Managing clinical data through a clinical data management system is key to:
- Generating satisfactory clinical research results and compliant submissions
- Controlling data entry, storage, and transmission
- Verifying the data are of the highest quality, integrity, and reliability
- Fast-tracking a drug’s time-to-market
- Providing better patient experiences and outcomes by reducing the drug development time
The Top Three Benefits of CDMS
Provides a global, controlled, standardized data repository |
For a clinical trial to be successful, the entire data entry and transmission process must be controlled and audited, and any data errors must be corrected. This process is easy with a few standalone PC-based systems, but hundreds of such systems are in modern clinical trials. For example, any changes, such as a form requiring an extra column or an analysis requiring another variable, would need the modification of hundreds of standalone systems.
Enterprise-wide, centralized CDM platforms allow one to govern and orchestrate the clinical data management and analysis process, lowering costs while increasing process efficiency, submission quality, and conformity. Other benefits include:
- The adherence to defined local and global standards
- A single source of truth system for reporting key performance indicators and statistical analysis
- High-quality study submission packages
- Decreased operations costs for both IT and the business
- Consistent automated data collection that avoids user bias or other variables that could manipulate outcomes
Ensures compliance
Standards management is important for contract research organizations (CROs) and pharmaceutical companies. In all clinical and non-clinical research, these companies must adhere to the standards and guidelines set by bodies like Clinical Data Interchange Standards Consortium (CDISC). Because of the increased volume of clinical trials, regulated authorities such as the Food and Drug Administration (FDA) have mandated that study submissions follow the highest quality standards and are ramping up regulations. Thus, a clinical data management system is required to ensure that submitted data meets the latest standards.
It is now important to meet all these regulatory and compliance needs, including the audit trail of information storage, user accesses, data exchanges, and data security, to avoid any corrective and preventive action. Clinical data management platforms can govern and orchestrate this data and analysis process. For example, CDMS has CDISC-compliant templates that simplify designing and exporting electronic case report forms (eCRFs).
Because the CDMS requires a validated environment, clinical data must meet all regulatory compliance requirements. As the FDA defines in Title 21 of the Code of Federal Regulations (21 CFR Part 11), any CDMS design must meet the regulatory requirements for electronic records and the security requirements for a closed system.
All electronic records and electronic signatures must adhere to 21 CFR Part 11, which defines data compliance and submission requirements. Some of the critical, compliant requirements that the CDMS should meet are:
Electronic records control: the system must reproduce electronic documents accurately and completely, with a complete audit trail of dates and metadata.
Proper sequencing of steps or transactions: a defined security hierarchy should control the object life cycle, data access, and system functionality.
Procedural controls: the system should be able to perform revisions and track who made the changes. Additionally, when the transaction/operation occurs, the system must support electronic signatures.
Reduces the time it takes to complete clinical trials, submit applications, and launch drugs.
The time required for a drug to go from development to launch and marketing is determined by the quality and integrity of clinical trials after regulatory authorities receive the submission. To streamline and speed up the review process, regulatory agencies must collect clinical submissions that are complete, high-quality, and meet the various standards. Using CDMS, clinical data management service providers facilitate a faster, more seamless process that reduces the costs associated with lengthy drug development while shortening time-to-market.
Final Words: CDMS Ensures Data Harmonization, Standardization, and Compliance
The need to standardize data inputs and replace all manual methods of working with electronic systems, combined with an increasing number of clinical trials and tighter regulations, drives up demand for CDMS. Regulatory agencies like the Food and Drug Administration (FDA), the Pharmaceuticals and Medical Devices Agency (PMDA), the European Medicines Agency (EMA), and others are gradually transitioning to integrated electronic systems. Thus, submission formats are becoming more standardized in order to meet the requirements of submission review platforms and systems.
Clinical data management service providers like Element Technologies lays the groundwork for error-free data collection and high-quality data submission, resulting in faster drug discovery and shorter time-to-market. We help organizations implement this technology to meet rapidly evolving technological and business needs while adhering to standards-based clinical entities. Contact Us for more information on clinical data management systems.