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Think of a world without clinical trial data management. Shivers.
Data collection and storage are important in several industries, especially healthcare. When research teams conduct studies that test new medications or treatments on people, collecting, analyzing, and preserving that information is of the utmost importance.
Since human clinical trials have implications that affect a large population, it only makes sense to leverage advanced technologies to make the data management process more efficient.
Electronic data capture (EDC) software enables researchers and businesses to capture and store clinical trial data. The software simplifies data sharing and exporting and allows seamless clinical trial proceedings.
Electronic data capture (EDC) is software that stores patient data collected during clinical trials. EDC systems are also used to document and manage data in clinical research studies. The technology replaces traditional, paper-based data collection methods and seeks to reduce clinical trial and drug development timelines and costs.
While there are many electronic data capture systems variations, most offer options to streamline data collection, verify data quality through logic checks, and improve reporting measures. A good EDC software must be a centralized repository for validated, secured, and locked data ready for analysis after the trial.
Our societies have come a long way, especially when leveraging advanced technology to facilitate simpler and more effective processes. The clinical research industry is a prime example of this.
Digital tools and technologies are currently for data management, research study feasibility assessments, and eases data collection. Most clinical trials use EDC systems to bolster existing clinical trial management software.
Every clinical trial is different from another, necessitating a specialized design mechanism and implementation process.
Before using the technology to manage data records, stakeholders must develop several plans to note the execution procedures. The two main plans are a data management plan (DMP) and an annotated case report form (aCRF).
A DMP outlines the expected data and the ways to collect, clean, analyze, store, and share the acquired information. At the same time, an aCRF helps document the data’s location along with the names of the datasets and variables present.
Once the plans have been established, the system is designed using system specifications for the clinical trials. The main steps to building the software are implementation, testing, and data validation performed by the data management team of a CRO.
Technology is always evolving to keep up with new demands and changes within the healthcare sector. While each electronic data capture solution is different based on its specific purpose, some common features are present in any good EDC software.
The primary feature of any EDC software is to organize data into appropriate forms. Data export occurs when the data is ready to be pulled out of the system to access exportable patient information.
Identifying and resolving data discrepancies is critical for an EDC system. Streamlining communication between all stakeholders and having capabilities for both auto-generated and manual queries before data locking is essential to the query management process and research outcome.
Data is only as messy as the process it goes through.
Regardless of the data source, all information in clinical trials must undergo data cleaning, filtering, and sorting. This also includes organizing sources and presenting clear clinical reports to showcase the value of the treatment or drug used in the trial.
Effective data cleaning practices consider all kinds of errors - typographical, missing data, implausible values, and nonrandom misclassification mistakes. Shifting to EDC systems can help eliminate manually entered errors and incorrect information from data warehouses and administrative databases.
Having a tool that allows for data cleaning makes it easier to identify outliers within data sets, which helps researchers review the information. Processing data provides insights into whether the information needs to be corrected or removed.
Most EDC platforms enable the design of electronic case request forms (eCRFs) that imitate paper forms. eCRFs are saved in a library and used across multiple protocols to eliminate form repetition. EDC systems also have edit checks programmed to prevent invalid data entries while building forms.
After the data is collected, cleaned, and reviewed, the trial findings are presented to the relevant regulatory authority, such as the Food and Drug Administration (FDA), for approval and distribution.
Electronic data capture platforms are widely used to create customizable reports that integrate with electronic health record (EHR) software. Data reports generated by an EDC system are integral to the final clinical study report as they provide comprehensive information regarding the trial’s objectives, contextual research, and final results.
As with all major industries, the clinical trial field is also starting to warm up to the idea of cloud computing due to its powerful security and sharing options. Historically, the cloud has been considered bad for hosting and storing medical information, but many pharmaceutical companies and regulators are moving towards using cloud-based EDC systems.
Clinical studies that employ cloud-based platforms have access to real-time data, immediate feedback loops, instantaneous data transfer, and protection from hackers. Cloud-based EDC software allows for multi-center and multi-language studies to be organized in a single data center which is vital for global human clinical trials.
Data verification is one of the most significant clinical trial data management steps. Researchers need to verify information accuracy since it is personal.
Before the COVID-19 pandemic happened, this verification took place on-site by employees of different stakeholders. However, remote technology has led to a rise in the need for remote data verification.
Remote source data verification (rSDV), a crucial component of the final data cleaning process, can now be centralized and performed off-site. Many researchers, sponsors, CROs, and regulators feel an increase in rSDV capabilities is a win for conducting non-emergency trials and having more control over the data.
Clinical research organizations commonly use electronic data capture systems in the greater life sciences industry. There are five main categories of EDC software users:
A site is an entity such as a clinic or hospital that coordinates and collects information from patients involved in clinical trials. People employed by these sites are responsible for making data entries into EDC systems. The doctor or physician in charge of the patient’s care reviews and signs the data electronically.
A stakeholder that typically “owns” the clinical trials is the sponsor for that study. Examples include biopharma companies such as Pfizer or Novartis and other life sciences organizations that financially sponsor clinical trials. Sponsors require approvals for medical innovations from the national regulatory authorities before going to the market with their products.
The use cases for EDC software are manifold for trial sponsors. The technology can be used for data verification and document reviews. Trial sponsors employ monitors or coordinators to help ensure all the steps and processes are carried out smoothly. This can be done either on-site or virtually.
Research and trial study participants use EDC tools by providing data either directly into the system or through a connected application. Patients engaging in data entries are part of an electronic patient-reported outcome (ePRO) practice.
Electronic data capture systems also see heavy use by data managers and biostatisticians who use mathematical principles and apply them to biology and data.
These stakeholders, along with clinical research associates (CRAs), simplify query management and ensure that the data is clean and usable.
Companies that form contracts with trial sponsors are responsible for overseeing the planning and conducting of the clinical trial. These contract research organizations (CROs) can sometimes act on behalf of the sponsor, but they most frequently take on key roles in the entire data processing activity.
CROs generally leverage EDC systems as trial sponsors. These businesses also use contract management software for academic or research purposes.
EDC systems make managing clinical trial information easier. Since it eliminates the need for the traditional, manual process of data collection and review, EDC software can also pair with other clinical research software to improve overall data and study efficiency.
Clinical trial data provides insights into discovering different ways to detect, diagnose, and develop new treatment options for diseases. So it’s a no-brainer that having access to this information sooner rather than later helps save lives. Electronic data capture software is known for its time-saving benefits as they give real-time access to data.
Quicker entry points to data also allow for a faster rate of data analysis and increase the pace of research studies. Good EDC systems are designed in a highly intuitive manner and only require a few hours of training, reducing time spent in query management.
Clinical trial data must be secured and protected from external threats.
EDC systems are hosted online, and all data entries are completed on a web-based interface. Since the collected data is highly confidential, EDC software vendors must ensure maximum data protection and backup. Third-party security coupled with designated user permissions lowers the chance of potential data breaches.
Manual data processing always comes with the possibility of inaccurate data entries. Data processed electronically can be filtered by adding specific rules and constraints to avoid the scope for allowing illogical values. This results in more conscious data filtering practices and enables automatic calculations for accurate entries.
Most EDC tools have an easy-to-use interface and user-friendly navigation features. Having search options makes it easy to filter preferred information from a sea of data, allowing better visibility.
Data that is easier to sort through can be effortlessly stored in denoted files and folders to prevent information overload and loss.
Data from clinical trials is legally bound by regulatory and security compliances. All EDC systems must comply with regulations such as 21 CFR Part 11, which outlines the electronic administration of medical records.
To maintain data standards, vendors and users must have all necessary technical controls and standard operating procedures.
Electronic data capture is great for clinical trial data collection but is not a perfect system. Some of the limitations of using EDC software include:
Although electronic data capture and electronic case report form are very different, they are often used interchangeably.
An EDC is software widely used for collecting, analyzing, and reporting clinical trial data. An eCRF, on the other hand, is a digital questionnaire used to collect participant data.
While both are used to collect data, EDC solutions are more concerned with the study, and eCRFs are more patient-centered as they transcribe data from medical charts.
An electronic data capture system differs from a clinical trial management software (CTMS) because it helps gather patient information necessary to conduct clinical trials. It collects, tracks, and reports data from the trial sites. It also serves as a source database to perform digital experiments.
A CTMS, also known as clinical management trial software, is a tool that manages the operations and processes related to clinical studies or trials. The technology helps perform high-level screening and track anonymized subject records. It can also be used to streamline workflows and optimize trial proceedings.
Top five clinical trial management software:
*data collected from G2.com on May 18, 2022.
EDC and CTMS software complement one another and intersect during project management of clinical trials. It is beneficial to integrate EDC data into CTMS solutions.
Collecting and recording clinical trial data streamlines the entire data management process. Good EDC systems improve data quality and efficiency simultaneously.
To qualify for inclusion in the EDC category, a solution must:
*Below are five EDC software based on G2 data collected on May 18, 2022. Some reviews may be edited for clarity.
Medrio EDC is an EDC platform that complements other eClinical solutions such as ePRO, eConsent, and direct data capture (DDC) solutions. It is used in pharmaceuticals, biotech, animal health, and diagnostic companies. Its skip logic and edit check features make data processing efficient.
“I love how easy it is to design CRFs, build edit checks, and perform dictionary coding within the system. It is also easy to move studies from other databases to Medrio. I retrieved at least two research studies and successfully implemented them in Medrio.”
- Medrio EDC Review, Hitesh W.
“The data recorder is not smart and easy to use. It requires writing down the normal range and unit of measurement every time. This increases the time to fill laboratory test results .”
- Medrio EDC Review, Nigel H.
REDCap is a web-based application for building and managing online surveys and databases. It can collect any type of data and is specifically geared toward supporting online and offline research data capture. It has a vast support network of collaborators and thousands of active institutional partners.
“The CRF form designer is user-friendly and customizable. The EDC platform has fantastic query tracking capabilities, and the dashboard provides comprehensive insights. Complex skip patterns and logic are easily programmable, and I can export data in formats like csv, spss, and stata.”
- REDCap Review, Swapnil R.
“Data filtering is a little challenging as the software populated different results for a single search query. There are no additional ways to sort through this information except to choose each one individually. The exportable excel reports could also use a bit of cleanup.”
- REDCap Review, Taylor M.
A remote data capture system, Oracle Clinical provides a single application and infrastructure for electronic data collection and clinical data management. It streamlines randomization and trial supply management to unify data and save time.
“This is the best EDC tool I’ve used so far and is easy to use. I work with oracle clinical tools and platforms like Inform Clinical. I am delighted with the updates they come up with.”
- Oracle Clinical Review, Rajdip C.
“It duplicates the files inside the system, especially when opening a new file. It usually takes an hour to load an information-heavy case, and the system often crashes with low bandwidth.”
- Oracle Clinical Review, Chriesta Marielle T.
Castor EDC is cloud-based electronic data capture, eCRF, ePRO, eCOA, eConsent, and decentralized trials platform. The technology enables researchers to capture and integrate data from sources in real-time easily. Users can build a study within hours with the intuitive form builder, and the tool is compliant with all necessary regulations.
“Castor is VERY user friendly. We do several studies, and our staff requires a lot of CRF training. We’re finding fewer 'user mistakes' in the data we collect, and the forms are filled out intuitively, which saves a lot of time for data quality monitoring. The system is fast, and the helpdesk is always available to answer queries.”
- Castor EDC Review, Anne-Floor Q.
“I would like to have a more interactive view of included and excluded patients by incorporating colors. Additionally, when sending a survey to a patient, I am required to fill out the email address in the first list through a 'change email' action. This feels like an unnecessary action and creates scope for errors. An option to receive one output file instead of separate files per survey during data extraction would also be nice.”
- Castor EDC Review, Gwendolyn V.
A clinical research solution provider, OpenClinica EDC software automates data capture with dynamic, comprehensive eCRFs for clinical trials. Researchers are equipped with the tools to collect better data and report it quickly and easily.
“The software was quick to implement and easy to set up with admin and user privileges. Building question forms is also a simple process after reading the documentation provided. Small file backups and the capabilities of saving result codes for interpretation and analysis is a plus point.”
- OpenClinica Review, Michael B.
“Viewing, answering, and resolving queries is not user-friendly. It is unclear which forms contain queries, and answering queries is tedious and not intuitive. The display is also confusing with multiple pop-up windows and options for drop-down responses.”
- OpenClinica Review, User in research.
Discovering new medical inventions provides critical insights into the overall health of patients and the general public. Clinical trials establish the effectiveness of changing healthcare systems and deal with data that must be collected and reported correctly.
Employing the right technological solutions ensures successful clinical data management and outcomes, saving time, money, and perhaps, lives.
Maintaining data quality is ineffective if the information is not well protected. Learn why focusing on data integrity is integral to improving data quality, consistency, and authenticity.
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