FGK’s eCRF

• Disease-Specific Characteristics: Implementing eCRFs tailored to specific disease areas, ensuring relevant data capture and analysis.
• In House Design and Planning by eSolutions department: Utilizing internal resources to design eCRFs and improve responsiveness and adaptability to project workflows. We offer the eCRFs by industry-renown Software companies Viedoc and Veeva.
• Broad Experience with a great number of eCRFs: Should you plan to utilize eCRF services by a third provider, FGK’s project team seamlessly integrates in the desired vendor structure.

As paper CRFs, eCRFs can be tailored to suit the specific needs of a clinical study, from simple case forms to complex, multi-page documents that capture detailed medical data. But the electronic format supports immediate data validation rules and fast role out of protocol amendments, ensuring that the collected data easily meets predefined standards for accuracy and consistency.

The structured nature of eCRFs simplifies data analysis, providing clear, actionable insights that drive the research forward. In addition, real-time data entry and surveillance allows for immediate identification of trends and potential issues, enabling timely interventions and adjustments to the clinical plan. Data from other third parties (e.g. central laboratories) can be easily integrated.

eCRFs as well as paper CRFs contribute to the transparency of the trial process, ensuring that all data is traceable and verifiable. This transparency enhances the overall value of the research findings with providing detailed reports and analyses that inform clinical decisions and support regulatory submissions.

eCRFs streamline case management by providing a centralized system for tracking patient information and trial progress, which can be accessed by all team members regardless of location. Automatic notifications can be configured to be sent when certain events occur (e.g. serious adverse events), ensuring immediate information of relevant personnel.

One of the biggest arguments to chose electronic CRF is the built-in validation checks which ensure data integrity, reducing the likelihood of errors and enhancing the reliability of the study results. Of course, eCRFs are also designed to comply with regulatory requirements, providing a secure and audit-ready electronic system as well as robust security measures, including encrypted data transmission and secure access controls, to protect sensitive medical information.

Flexible and efficient coordination of all Electronic Data Capture (EDC) activities through In-House eCRF design and management at FGK – you just need to press the button and access the data you need.

The advantages are:

• State-of-the-art validated software and security technology in terms of access control, role-based permissions and data availability
• Real time access to safety data – any time and anywhere enabling e.g. real-time decision support in DSMBs
• Visualization of actual status on data quality (missing data, queries, SDV status etc.)
• Increased quality: Using automatic edit checks of an EDC system does significantly reduce the error rate in data entry
• Increasing compliance: Easy-to-implement and use at study sites, no need to install special software or maintain a local data base, low demand for computer related skills by study personnel
• Time savings: Early identification of discrepancies or data entry errors by remote monitoring, often minimizing the time spent by monitors at sites
• Cost savings: The cost of the clinical trial can be reduced thanks to remote monitoring, less frequent site visits, elimination of printing costs, faster data entry, and lower data cleaning costs

Electronic Case Report Forms (eCRFs) have revolutionized the landscape of clinical research, offering unparalleled benefits in data management, real-time surveillance, and regulatory compliance including CDISC conformity. FGK Clinical Research, with its extensive experience has harnessed the power of eCRFs to streamline clinical trials across diverse medical indications.

FGK Clinical Research’s extensive experience with eCRFs underscores the value of these tools in conducting high-quality, reliable clinical studies. As the field of medicine continues to evolve, the role of eCRFs in enhancing design, management, and reporting of clinical trials will undoubtedly become even more critical, ensuring that medical research can keep pace with the ever-growing demands for precision and transparency in clinical data.

Find out more: All of FGK’s eSolutions

For more information on our eCRF contact FGK today.