Clinical trial management systems (CTMS) are an important part of any clinical trial. Choosing the right CTMS helps address inefficiencies on the operational side of research, such as planning, preparing, conducting and reporting clinical trials. As more pharmaceutical and biopharmaceutical sponsors begin to realize the potential opportunities offered by EDC-CTMS integration, there is a growing need to address the complex process of implementing electronic data collection (EDC).
EDC Clinical Trials is used to help medical device and pharmaceutical companies achieve maximum efficiency in data entry, database structuring and clinical trial analysis.
What Is EDC Clinical Trials?
EDC Clinical Trials technology has evolved as earlier concerns about data integrity caused by human error and connectivity issues caused by less reliable IT systems have become a thing of the past. Hospitals around the world are better equipped, staff are much more comfortable with electronic systems, and stakeholders are now much more aware of the time that can be saved by using EDC.
In the last decade, the use of EDCs in clinical trials has become more significant, with the global market for EDC Clinical Trials systems estimated to reach a value of almost €935 million by 2025.
As the medical industry embraces new technologies and innovations, including electronic record keeping, the volume of information collected before, during, and after clinical trials continues to grow. Comprehensive data collection and effective management is therefore now becoming a priority for pharmaceutical companies and clinical research organizations (CROs).
Switch to EDC Clinical Trials
The advent of EDC Clinical Trials technologies is shaping the clinical trial data management landscape and offers many benefits to industry. Adoption of EDCs instead of paper methods has been slow at first, but users can do things with EDCs that they cannot do with paper case report forms (CRFs) or standard databases, creating a strong case for investment. There has been a major shift in the adoption of EDCs in the last few years, with paper CRFs now only being considered for very specific requirements.
Digital templates can be easily modified to suit each new study, saving time that would have been spent designing and producing paper CRFs. On average, EDC Clinical Trials has been shown to reduce study prep time by 41%.
EDC Data
With EDC Clinical Trials, data is collected and entered into the data collection tool only once, with a paper system, data must be entered first into the case report form and then into the electronic system by the data entry team. This not only increases the processing time, but also affects the integrity of the transcription.
EDC also allows for immediate data cleaning and does not require the intensive work of a data management group for processing. Unlike paper studies where a data management team performs logic checks against data collect weeks or months ago, EDC’s logic checks performs when the site enters and submits the data, allowing it to look clean in real time.
Ultimately, with proper system selection and development and good study management, EDC allows users to quickly access clean data with low operating costs. Switching to an EDC has been reported to save an average of 30% of the time required to conduct a clinical trial[2].
Creation of a comprehensive EDC Clinical Trials database design
Time and resources need to invest to ensure that each test database is thorough. If companies do not make this investment, there is a risk that changes or additions will need later, which will be costly and could have a wider impact on operations.
Most EDC Clinical Trials systems come with a standard set of reports, however additional reports may need for study oversight and management. Most good EDC dealers can provide additional custom reports. As with database development, report design should well consider and clearly specify at the outset of a study.
When designing an EDC system, it is also important to consider the format in which the data is collect so that it can statistically interprete or programm in other third-party software once it leaves the EDC Clinical Trials system. Implementing a consistent data collection methodology involves standardizing definitions for data that has been collect in multiple locations.
EDC And Clinical Trials
EDC systems must be able to comply with Clinical Data Interchange Standards Consortium (CDISC) standards and datasets must be compliant with the Clinical Data Acquisition Standards Harmonization (CDASH) guidelines to be future ready for statistical analysis. This can save time and efficiency as non-CDASH data must reprocess to meet the CDISC standard when submit to regulators.
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Using a larger number of standard designs when compiling studies can not only help with the efficiency and quality of reporting, but also significantly reduce the time required to compile databases.
The role of outsourcing
It is important to provide high-quality clinical data management to support drug development needs and ultimately bring products to market as quickly as possible. The specializ nature of clinical data management has led to an increase in the outsourcing of these services in the pharmaceutical industry, especially by specializ CROs with a deep understanding of what is need.
This is especially true for smaller companies that lack the financial resources and in-house expertise to effectively implement these capabilities themselves.
Outsourcing data requests to specialized CROs allows sponsors to leverage CROs’ process knowledge, their standard libraries built over time, and the expertise and learning gained from working across technologies and protocols. By focusing solely on data, CROs can offer an efficient and flexible clinical data management solution, as well as add another layer of quality control to the process.
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