Reasons Why Clinical Trials Need Edc Software

Clinical trials, also known as clinical studies or clinical investigations, are processes aimed at assessing the potential efficacy and safety of a medical drug or equipment before releasing it to the mass market. To make that determination, biostatisticians analyze data recorded on Case Report Forms (CRFs) by the investigators working on each case. 

Before the advent of advanced medical technology, case report forms were typically completed on paper. The huge stacks of paper were then packed into boxes and shipped from the location of study to the destinations where they would be further synthesized. However, this is no longer the case. 

Modern technology has primarily rendered obsolete the need for manual CRFs, and their place has been taken over by web-based services known as EDC software. Read below for everything you need to know about EDC software, with a particular focus on the benefits of these services in clinical trials.

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What Is EDC Software?

EDC is an abbreviation for electronic data capture. It’s a digital service that helps with data collection, analysis, storage, and management. 

EDCs have become the go-to services for clinical research centers looking for efficient data management systems. And it’s reassuring to know that the industry teems with companies offering these solutions. A notable mention is EvidentIQ. 

EvidentIQ EDC software comes with all the basic features you’d expect in any electronic data capture service. But what truly sets this software apart from its competitors is its nifty clinical data management specs, including its real-time ability to provide information.

Benefits of EDC Software

Improved Data Accuracy

Data inaccuracy is arguably the biggest drawback to manual case report forms. The inconsistencies mainly arose from the fact that many clinical investigators couldn’t record their findings in real-time. The time lags between data capture and entry significantly affected the integrity of the recorded information. 

Fortunately, data accuracy isn’t an issue with electronic data capture software, as these services can record information in real-time for improved consistency checks. Data managers can quickly pick up any discrepancies before affecting the study’s credibility.

Enhanced Legibility

Handwritten data may have a more realistic appeal than its typed counterpart. However, typed information is a clear winner in terms of legibility. When manual CRFs were still the in-thing, much information was lost simply because data interpreters couldn’t make out clinical investigators’ handwriting. You can only imagine what would happen if illegible information, such as drug dosage guidelines or machine safety controls, were highly sensitive.  

With electronic data capture, all you need to do is select your desired typeface. And nearly all primary fonts are legible enough.

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Better Data Security

Clinical data is susceptible information that must be guarded at all costs, at least before it’s deemed safe for public consumption. 

During the era of manual case report forms, there were always risks of classified medical information slipping into the hands of unintended parties. Such incidents mainly occurred when the CRFs were lost or misplaced during transit. 

Computerized systems have primarily succeeded in minimizing the loss, theft, or damage of sensitive clinical data. EDC software vendors ensure their data is protected and backed up using hacker-proof systems. The software further provides designated user and role-based access controls (RBACs). Some may also include multi-factor authentication for an extra layer of data security.  

Improved Accessibility

Electronic data capture services have also been instrumental in enhancing the accessibility of clinical findings. Since the information is hosted online, designated users can access it from virtually every corner of the globe, provided they have stable internet and access privileges. 

Before this technology, a clinical trial conducted in Japan would take months to get to the United States. This greatly impeded service delivery, especially during pandemics and other medical emergencies whose success relied upon ongoing clinical investigations. 

Improved data accessibility allows clinical managers to study emerging trends and make informed decisions.

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Higher Data Quality and Flexibility

Once information is captured on a manual case report form, it can only be erased but not edited. That inflexibility makes it difficult to modify existing research for use in a new study. 

Fortunately, digital templates are incredibly flexible. You can edit specific information multiple times without affecting the quality of the entire document. 

Besides, there’s less time to feed information to electronic data capture systems. That’s because the data is entered once from the trial site. For comparison, you’d need to record clinical findings on CRFs and then transfer the document to a centralized database. 

The best part about EDC systems is that they can integrate with third-party data management software for better data quality control. These include editing and numerical data validation software.  

Reduced Operation Costs

Lastly, electronic data capture systems can lower the costs of conducting clinical trials. 

The cost of buying and installing EDC software may be considerably high. But it’s a one-time purchase compared to manual case report forms that would need to be bought from time to time. 

Besides, EDC solutions reduce the cost of hiring many data entry clerks since the information is only fed into the electronic systems once. 

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Final Word

Evidently, there’s a lot to gain by switching from manual case report forms to electronic data capture solutions. Remember to conduct your due diligence while choosing the best EDC software.

Medical Disclaimer: All the content available on the website is just for informational purposes. It’s not a substitute for any Professional advice. Don’t take it personally. As a medical student, I’m just trying to use my information through my content, and please keep in mind it’s not written by a professional doctor. Use the data just for educational purposes.

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