Please contact us at info@zlynger.com if you need an EDC system for your clinical trial
Over the past few years, the clinical research sector has experienced an unprecedented demand for new drugs and therapies to treat different types of diseases, which has led to the proliferation of a large number of clinical trials. Not only that, but this trend is expected to continue as the market expands and more treatments are investigated.
Evidence of this rise in research and development activities in the biotech and pharma industries can be seen in the fact that the global clinical trials market is expected to be worth around USD 83.5 billion by 2030. Moreover, according to the Transparency Market Research, this market is estimated to grow at a CAGR of 5.4% from 2020 to 2030. [1]
This global phenomenon has brought with it new scientific and clinical challenges posed by the increasingly stringent regulatory requirements and the high levels of competition in the health sector. In this context, biotechnology companies are adopting new approaches and seeking to enhance the application of emerging technologies in order to better address the greater complexities of clinical research projects and practices.
In light of these changes, many research organizations and independent investigators have leveraged on advanced software applications, medical devices and technological resources to ensure accurate data and accelerate all the processes involved in a clinical trial. In particular, they have realized the advantages of using an Electronic Data Capture (EDC) system to support clinical studies.
Zlynger is a clinical research technology provider that has extensive experience in offering software tools for medical applications, as well as data management services, to biotech and pharma companies, academic research groups, university hospitals, and independent investigators conducting clinical studies worldwide.
In this article, we will focus on the most important aspects of EDC technologies and the advantages regarding the use of Zlynger’s EDC software in clinical research.
What Is an Electronic Data Capture (EDC) System Used for in Clinical Research?
An Electronic Data Capture (EDC) system is a web-based software application used to collect, clean, process and transfer data from patients in clinical trials. It is a fundamental software tool as it guarantees that all clinical data are captured in a safe and accurate manner.
Nevertheless, it was not until the late 1980s that data started to be stored in an electronic format for use in human clinical studies. In the past, all the data produced during the patients’ participation in a clinical trial was collected on a paper CRF (case report form).
However, the use of paper and pen for clinical data collection proved unfeasible as clinical trials became more complex and diverse. This phenomenon occurred in part due to the tightening of regulations and standards issued by the government and health authorities to be in line with ethical advances in human data protection. As a result, obtaining a totally accurate CRF became a crucial goal of trial sponsors.
Certainly, using paper CRFs to capture data may be inconvenient and insecure. On the one hand, manually transferring patient data from paper CRFs to clinical databases is a very tedious and time-consuming process. On the other hand, this manual system can also be error-prone, meaning that the data collected is seldom completely readable or reliable.
In order to prevent these potential problems, a growing number of health research organizations and software providers are developing and refining web-based EDC systems for biotech and pharmaceutical research.
In actuality, EDC systems have many advantages over paper CRFs. For example, they are considerably faster and more efficient than the traditional form of data collection. In addition, this software can be even designed to provide specialized solutions targeting certain study phases or customer profiles.
Moreover, in contrast to paper CRFs, EDC systems are more environmentally friendly and secure. Modern EDC systems can also include groundbreaking technology features like case report form design modules, cloud data storage, and interactive dashboards, just to name a few.
Nowadays, a great number of clinical research specialists can benefit from an EDC software. These professionals range from principal investigators (PIs) and clinical study coordinators to sponsors, clinical data managers, and clinical research associates (CRAs).
All in all, EDC systems have absolutely become a fundamental tool on the grounds of their many technical and practical aspects. Definitely, they help streamline workflows and guarantee data integrity during all phases of clinical research.
Why Should You Choose Zlynger’s EDC Software?
Zlynger is perfectly aware of the importance of providing efficient and cost-effective technological solutions to customers. Drawing on our applications expertise, products, support, and client proximity, we are able to provide the right technical solution to help biotech companies achieve higher levels of optimization in their research projects and, as a result, help them succeed in the global clinical trials market.
By the same token, we know that choosing one Electronic Data Capture (EDC) system or another may determine the success, or failure, of a clinical trial. For that reason, we assist sponsors in selecting the most suitable EDC for their clinical studies.
Zlynger offers different EDC solutions adapted to the specific needs of each client and clinical study. Our innovative EDC software tools integrate a comprehensive list of industry-leading characteristics, some of which are described below.
Intuitive, easy-to-use EDC software tools
The EDC systems offered by Zlynger stand out for their highly intuitive interface and clear design. Zlynger’s EDC software enables researchers to easily enter data and solve queries. This unique ease of use will help sponsors obtain high quality data quickly and effortlessly. The usability and multiple integrated features of these software tools are appreciated by both customers and end users.
Simple study setup and management
Zlynger’s EDC applications are characterized by their easy study setup, integration, and management. Our EDC systems are fully web-based and do not require any software installation in the computer. Our integrated EDC solutions combine simplicity with complex, customizable workflows. As a result, our software tools optimally enable seamless data flow and support advanced clinical trial processes.
Advanced EDC systems for capturing drug efficacy and safety data
In clinical research, it is essential to assess both the efficacy and safety of the drug under investigation, that is, the highest benefit that can be achieved with a certain medicine, and the extent to which it is safe for all the people involved. After all, protecting the integrity and health of the human subjects participating in a clinical study must always be given the highest priority.
Zlynger’s EDC systems aim to enhance the quality of clinical data, ensuring that all efficacy and safety information collected is accurate. On the one hand, our EDC solutions enable the implementation of disease-specific forms, which will help investigators to accurately capture drug efficacy data. In the case of oncology trials, these advanced software tools can also facilitate the evaluation of clinically relevant endpoints such as reduced pain, improved quality of life, progression free survival (PFS), best overall response, and overall survival (OS).
On the other hand, considering that drug safety is one of the main endpoints in clinical investigations, Zlynger EDC systems also provide health care professionals with tools to evaluate drug-related toxicities. As an example, it allows the implementation of adverse event forms to register treatment-emergent adverse events (TEAEs).
Data management for studies of any size and stage
Another key aspect of Zlynger’s EDC software is the fact that it can be used in clinical studies of any size and phase (1, 2 or 3). Not only that, but it is also used in observational or post-approval studies and across multiple therapeutic areas, such as oncology, cardiovascular, hematology, metabolic, dermatology, and many others. In brief, Zlynger’s EDC systems are flexible and versatile applications that can help optimize studies of any size, phase, and therapeutic field.
Wide data access capabilities in global trials
The challenges brought about by large global clinical studies involving several clinical sites should be considered when adopting an EDC system. Zlynger’s EDC platforms enable fast, simple, and secure clinical data entry and processing for studies conducted internationally, spanning not only multiple nations, but even continents.
Complete compatibility with multiple devices and operating systems
Zlynger’s EDC systems are also characterized by their high level of quality and compatibility across multiple hardware and software platforms. In other words, they operate in most web browsers, mobile devices and operating systems. This great technical compatibility and interoperability with other programs and devices facilitate the development of purpose-built solutions.
Powerful real-time metrics panel
Data completeness and accuracy are a sine qua non for obtaining satisfactory clinical research outcomes, something that has been considered in the EDC products offered by Zlynger. Zlynger’s EDC technologies integrate powerful, real time-metrics panels that permit data tracking and control.
Efficient data cleaning and review
One of the main features of Zlynger’s EDC systems is their exceptional ability to facilitate cleaner trial data in a shorter period of time. Our EDC technology brings value to clinical research as it corrects data entry errors, validates data structures, formats, and ensures data integrity while making the data easy to review.
The potent data review and query management functionalities of Zlynger’s EDC systems will help investigators and data managers accelerate the data cleaning process and keep data quality high, which will drive better results.
Ideal EDC tools for managing randomized trials
Zlynger’s EDC solutions also enable automatic and secure randomization processes, even for highly complex multi-arm trials. Thanks to randomized algorithms, pre-computed static lists as well as dynamically generated randomized lists can be created. The adoption of our sophisticated EDC tools will certainly simplify your workflow and deliver easy-to-manage randomization.
Data exports in a variety of formats
The EDC platforms offered by Zlynger generate data exports in multiple file types, including CSV, Excel, SAS, PDF, and CDISC ODM formats. What is more, our advanced EDC software also makes it possible to pre-schedule and perform data exports at the user’s convenience.
Absolute compliance with regulatory requirements and data protection standards
An EDC platform must be compliant with international regulatory requirements and standards. In addition, it must be a validated system capable of ensuring the completeness and traceability of all the data collected. Indeed, most regulatory authorities are currently accepting only those submissions in which validated EDC systems are used.
Zlynger’s EDC software tools strictly comply with all these quality, security, and regulatory standards. In particular, our software products meet the requirements of FDA, EMA, CFDA, and JPMA, as well as data protection guidelines such as the GDPR, HIPAA, APPI, and PISS. Our software also ensures conformity with 21 CFR Part 11 requirements, which guarantees the integrity and quality of the data produced and collected in a clinical trial.
Attractive price and convenient billing model
Lastly, not only do Zlynger’s EDC solutions eliminate the costs associated with traditional CRFs, but the budget of the client is also taken into account. For this reason, we provide sponsors with an EDC software tool of the highest quality at an affordable price. Our aim is to offer a cost-effective technological tool to capture, manage, and report clinical research data, regardless of trial phase and complexity, which can fit the budget of each sponsor.
In essence, Zlynger’s EDC products are user-friendly software tools that guarantee high-quality data collection, cleaning, and analysis. This allows for fast study build, streamlines data workflow, and accelerates the execution of clinical trials and the approval of new therapies. With Zlynger’s EDC solutions, you can rest assured that patient data will be perfectly safe.
Conclusion
Zlynger is a trustworthy software provider with great experience in offering a wide range of software applications for the execution of clinical trials across the United States, Europe, and worldwide. We constantly strive to maximize the quality and efficiency of all the processes involved in clinical investigations by providing powerful software tools as well as enhanced data management services. Additionally, being aware of our clients’ needs and fully fulfilling them at any time and anywhere is an integral part of our business philosophy.
Today, numerous biotech and pharma companies, academic research groups, university hospitals, and independent investigators benefit from Zlynger’s EDC systems, accelerating data collection, cleaning, and exports in clinical trials of any phase and size.
Ultimately, bearing in mind the significant reduction in time needed for data collection, reporting and analysis gained from Zlynger’s solutions, we are also highly committed to reducing research-associated costs. Definitely, our products and services will bring real value to clinical research projects. For all these reasons, Zlynger is the ideal technology partner for sponsors conducting clinical trials worldwide.
Please contact us at info@zlynger.com if you need an EDC system for your clinical trial
References:
[1] Transparency Market Research. 2021. “Clinical Trials Market.” [Accessed 6 June 2022].
