Ever since its inception in the 1990s, Electronic Data Capture systems have created a huge impact and emerged as gamechangers in the life sciences industry. From the simple Remote Data Entry (RDE) systems to the advanced systems of today, it has evolved a long way. Speaking in general terms, the purpose of an EDC solution is to streamline collection, storage, and management of data in the clinical trial process.
The electronic data capture tools out there in the market today are equipped with a host of intuitive and advanced features to help accelerate the studies, enhance data quality, stay compliant with regulatory requirements, and ensure data privacy. In fact, many users of a survey agreed that switching to an electronic data capture system from the paper-based data capturing processes cut down 30% of time it takes to complete a trial.
Commonly used by the trial sites, trial sponsors, and CROs, these solutions are usually cloud-based and can be accessed securely via a web browser. So, what features should you look for while choosing an EDC system? We are listing a few below.
Ideal Features of EDC:
a). Connected Devices & Wearables Integration:
It should be able to collect and store data from external connected devices and wearables such as smartphones, smartwatches, tablets, and other smart devices that are being used by the study subjects as this integration will enable precise and real-time data capturing, participant compliance, and offer better insights into the study.
b). Adverse Event Reporting:
This is an important feature that should be embedded in the system as it will enhance patient safety, regulatory compliance, shed light on the right follow-up steps, and ensures timely reporting and documentation. This feature comes in handy for the researchers to record and manage the adverse events in a clinical trial.
c). eCRF Builder:
It should help clinical researchers build tailored electronic Case Report Forms (eCRFs) as per the study requirements without any programming skills. The eCRF builder feature makes the system adaptable and efficient for various research studies by simplifying data collection instruments creation process.
d). Electronic Patient Reported Outcomes:
The ePRO feature allows real-time gathering of patients-reported data, surveil the treatment effectiveness, and enhance participant engagement in the clinical trials, making the data collection process seamless, accurate, and convenient.
e). Clinical Trial Management System Integration:
Efficient data exchange between an EDC system and Clinical Trial Management System (CTMS) results in enhanced collaboration across research teams, data accuracy and trial oversight.
f). API Integrations:
The feature allows for smooth data exchange with external applications leading to better research capabilities and improved data interoperability.
Benefits of EDC in Clinical Trials:
But why should life sciences organizations consider using it? When implemented and adopted properly, it can offer many benefits including minimized human errors, improved data quality, accelerated research, and enhanced data security for clinical trials. Let’s explore a few benefits of EDC systems in clinical trials.
1). Compliance:
Clinical research is an extremely regulated field as the trials involve sensitive patient information and being compliant with all regulations is easier said than done. But researchers can ensure that they are in compliance with the regulatory requirements with the said solution.
2). Minimized Costs:
Deploying the solution for data capturing significantly reduces the overall cost of a clinical trial and improves the data quality by a great margin, minimizing the need for data cleaning.
3). Accelerated Trials:
Analyzing clinical data from paper-based CRFs is an arduous task and will take an insane amount of time. Logging the data directly into the data capture tool via eCRFs will cut down a lot of time with regards to data analysis leading to accelerated clinical trials.
4). Data Security:
It offers the best security to data from clinical trials. There is a near zero chance of data loss with eCRFs in EDC as they can be uploaded to the cloud instantly after creation. Moreover, it provides additional data security measures such as multi-factor authentication, and role-based access controls.
5). Data Accessibility:
With real-time access to the study data, the reviewers can start analyzing it right away. Ease of accessibility to data means quick and well-informed decisions!
6). Data Quality:
As we already know, it streamlines the data gathering process and this will reduce errors in the data. Additionally, software-based mechanisms such as data validation, edit checks, and remote monitoring further enhance the data quality.
Challenges of EDC:
While there is no denying the fact that EDC systems have made data collection a walk in the park for the life sciences industry, there are some challenges associated with it. Here are the top challenges:
– High Cost
The cost of implementation is one of the major challenges of EDC. Many factors such as setup and customization, training and support, integration with other systems, security and compliance, and data migration contribute to the high cost of implementation. Considering the time it takes to build database, numerous rounds of User Acceptance Testing (UAT), the overall cost is likely to exceed the allocated budget.
– Learning Curve
Becoming proficient in the new electronic data capture system and technology is among the top challenges. As with any new technology, the clinical trial investigators and participants will experience a learning curve for a while when moving from traditional data capture methods to electronic data capture. This might lead to slower data entry, more errors, and ultimately slow down the clinical trial process.
– System Technicalities
Solutions that are too complex require a thorough technical understanding and, in such cases, the clinical researchers and other stakeholders should really get down to nitty-gritty of the system. This will further complicate the designing of databases and capturing data efficiently, ultimately leading to delays in the completion of the clinical trial.
– Manual Workflows
Manual workflows refer to the complexities that arise because of some manual data collection and management processes despite having it in place. In a few cases, clinical researchers may continue to follow the paper-based processes to enter data manually which can create data inconsistencies and defeat the whole purpose of having an EDC system.
– Platform Rigidity
Many EDC systems are built rigid, making it a daunting task for the study researchers to tailor the solution to the fit the needs of the study. If a system is inflexible, it will be difficult to implement changes in study protocols, data collection methodologies, and regulatory requirements. These problems can result in inefficiencies, inaccurate results and delays in trials.
– Integrational Limitations
Integration limitations can affect the overall effectiveness of a clinical trial. If it is not able to be integrated seamlessly with other data sources or external applications, data exchange will take a hit. Integrating the electronic data capture system with other systems becomes increasingly complex if the data formats vary and more issues arise with differences in security concerns and interoperability issues.
Clinical trial sponsors, CROs, and trial sites encounter a flood of issues if there is no proper system to capture data. So how can they tackle such challenges without breaking a sweat? Well, the answer is InductiveEDC!
So how does Inductive EDC fit in the picture?
Inductive EDC (IEDC) by Inductive Quotient is a robust and cost-effective data capture system designed to help the life sciences industry efficiently handle the complexities of clinical data management. Equipped with powerful features that can accelerate clinical trials, streamline data management processes, enhance data quality, and ensure regulatory compliance. Now let us explore how IEDC can help you overcome the challenges in EDC.
– Affordable Cost:
Out of all the available solutions, InductiveEDC is the best tool that is lighter on the pocket but super-rich in features.
– User-friendly:
IEDC is developed to be an intuitive data capture tool with a simple and user-friendly UI that can efficiently cater to the needs of any clinical trial.
– Demystifying System Technicalities:
We have kept in mind the various challenges with other EDC systems while developing IEDC and built it in such a way that you would not need any technical knowledge to use it.
– State-of-the-art Features:
Equipped with simple drag and drop features, IEDC makes life easier for designers by minimizing manual tasks and expediting database design.
– Interoperability:
Is your existing EDC creating problems with integrations? Don’t worry, InductiveEDC got your back! You can integrate it with any tool/software of your choice in simple steps, greatly enhancing data interoperability.
– Highly Configurable:
IEDC can be customized to any level to meet the study requirements.
Do you want to know more about InductiveEDC and how it can help fast-track your clinical trials securely? Visit www.inductivequotient.com for more information about IEDC or reach out to our experts at hello@inductivequotient.com for a demo.