It's no secret that companies conducting clinical trials are not always eager to introduce technological innovations to change their processes. Many of them still keep paper records and diaries, as well as outdated software that can be as long as a decade.
In recent years, there has been a positive trend for clinical trial companies to incorporate software into their workflows. A recent study found that 64% of researchers have used digital health tools in their clinical trials, and 97% plan to use them within the next five years.
Before Clinical Trial Management System (CTMS) entered the market, industry players were faced with different types of solutions to replace the functionality of this software. After starting to use the new solution, people noticed that it helped eliminate inconsistencies in the information. This approach greatly improves the accuracy of data used in clinical trials. Therefore, there is a need for an integrated system that can simplify workflow and provide ease of use.
The adopted technology for automating clinical trials is called eClinical. Just as healthcare providers have their EHR software, life sciences researchers have e-clinics. These include a platform using electronic data collection (EDC), an interactive voice response system, randomization, and test delivery systems that eliminate the need to enter duplicate data in both solutions. It is worth noting that clinical trial automation is not a panacea that can solve all problems, but a business tool that analyzes performance metrics and helps improve it. Don't forget that CTMS also has its downsides, which we'll touch as well.
What is a clinical research management system?
A Clinical Trial Management System (CTMS) is a software system used to manage clinical trials in healthcare facilities. CTMS serves as the company's single, centralized network resource to support multi-site clinical trials.
In other words, CTMS is a project management tool through which physicians can set milestones and track progress, view performance of each team, plan subject access, manage relationships between different team members, control costs, and of course create reports.
CTMS seems to solve integration and consistency issues, as many modern solutions come with EDC support. In addition to Oracle, Bioclinica, and Medidata, popular systems include Parexel MyTrials, Forte OnCore, and more. But many systems in this field are outdated. With the benefits that IT technology brings to clinical trials, CTMS should be available to every pharmaceutical and biotechnology laboratory. If your healthcare facility is looking to replace an existing system or develop a custom system, we want to give you some ideas on what features might be useful and what to look for when choosing software.
This article takes a closer look at the best EPAM clinical trial management software currently available on the market. We also highlight its features and capabilities, as well as challenges that may be encountered when implementing ready-made solutions and why custom ones may be more beneficial for you.
Features To Look for in Clinical Trial Management Software
If you're looking for the perfect CTMS, we have a few things to keep in mind. As I said, the demand for these systems is relatively high right now, so more and more similar solutions are entering the market. Based on our experience developing medical solutions, we wanted to talk about the key capabilities that could be included in software for clinical trial management, and how they could provide a much-needed boost to clinical trials.
Investigator Profile
The profile needs to be embedded in the CTMS, and it usually contains some of the following information about the provider (name, address, license, degree, therapeutic area, and specialty). Currently, investigator profiles on these platforms focus on recruitment and compliance tracking.
Integrate with website
The CTMS needs to make all aspects of the study visible through the website so that users can easily monitor the research process. They help plan website visits by allowing users to view conversation history. These messages include surveillance and security letters, technical issues, introductory documents and payment requests. A CTMS portal that stores documents and manages service levels using workflows should also be integrated.
Solution optimization for mobile devices
We know that most clinical research professionals travel a lot, so being able to work from the comfort of a mobile device is critical. Many prefer cloud-hosted web applications with the convenience that these medical experts can always stay connected and access data from anywhere in the country or the world.
Acceptance of payments or donates
CTMS must enable prompt and accurate payments and efficiently handle contract terms to preserve the efficacy of research locations.
Implementation in the cloud
Early CTMS platforms had minimal to no scalability because they were locally deployed and used object-oriented programming. Today's cloud systems offer many other practical capabilities in addition to scaling. They can be swiftly deployed and used by partners and personnel both inside and outside the company with a variety of tools. This makes it possible for users to employ such devices in an unprecedented number of clinical settings and applications.
Resource administration
It is crucial to assign people to clinical trials based on their knowledge, availability, abilities, geography, and experience. They are essential to achieving national and research-level objectives.
Clinical Trials Management Solution Examples
Work processes and flows also become increasingly complex, busy, and in need of reform or redesign as a result of increased demand for items provided by the life sciences and burgeoning drug development pipelines. CTMS is ideally suited for this situation. Software engineers are constantly looking for ways to increase the capabilities of a single solution.
These days, a wide variety of such tools are available to buy. But we choose the most well-liked ready-made solution to save you time. We're hoping this will assist you realize which features are more significant to you and what you want your custom development to include, as well as clear up potential misunderstandings.
EPAM Cloud Pipeline is the clinical trial data management software. Usage of a cloud-based environment provides the ability to build and run the customized scripts and workflows that support genomics analysis, modeling and simulation, and machine learning activities that are required to accelerate patient treatment and drug discovery research.
The system combines storage and cloud computing resources into a single service, offering a simple and scalable method to carry out a variety of scientific operations. The primary attributes are:
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Data processing: Create data processing pipelines (workflow scripts) and run them in the cloud;
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Data storage management: Store and manage files;
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Tools management: Create and deploy shared and personal computation environments using Docker’s container concept;
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Scientific computing GUI applications: launch and run GUI-based applications using a self-service web interface.
Analysis of completed CTMS applications
If you begin searching for a CTMS solution on the internet, you will undoubtedly find dozens of ready-made apps designed for clinical trials that have a lot of the same features. It is uncertain that they are adequate to cover all essential clinical trials tasks and provide excellent oversight and control of those activities, despite their appealing interfaces and simple-to-use technologies. As a consequence of our investigation into the evaluations of well-known CTMS applications like Castor, MainEDC, Research Manager, and OpenClinica, we have compiled a list of the glaring flaws that almost all third-party CTMS vendor solutions have:
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Limited functionality is the most frequent drawback of ready-made solutions because the capabilities they provide do not always address all needs and procedures inside a particular firm;
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A limitation on the number of users/participants permitted/accepted, which limits how much the solution can be scaled;
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A few medical facilities can be added to the system for exchanging data on clinical trials;
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The loss of important documentation and the outcomes of earlier clinical studies is inevitable due to a lack of storage and space;
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Lack of automation and the requirement for manual labor in many situations.
Clinical Trial Management Challenges
Have you observed that each test phase has a number of persistent issues? We can link them to three important problem topics.
Drug development and research might take many years. The major issue, though, isn't even that; rather, it's that it gets more expensive, difficult, and demanding every year. The rate at which data is produced is increasing so quickly that managing it is becoming nearly impossible. The ideal solution isn't to use more software to process the data. Why? Continue reading to learn why.
Lack of unity. According to current circumstances, research specialists must operate with a dozen separate systems at once, while clinical trials often use four different data sources. Data originates from a variety of sources, including ePRO surveys, specialized applications, wearable technology, electronic informed consent forms, etc. Even though it's not impossible, it will take a lot of time and effort to analyze all of this data.
Clinical research document sequencing standards and data interchange standardization have recently been introduced.
Integration. Using some technologies, you can prevent document errors and prevent duplicate sensitive data from being accessed. Because specialists get varied degrees of technology training, this procedure cannot be totally automated due to the range of tools available.
Problem-solving solutions for clinical trials
Any change can be challenging, and it frequently is, particularly in a strictly regulated industry like clinical research. We can discuss and attempt to create some all-encompassing software, but will research organizations and sponsors use it? Most likely not. However, there is a solution:
CDISC Clinical Data Standards adoption
An organization that develops standards to assist data interchange in clinical research is called the Clinical Data Exchange Standards Consortium (CDISC). Their criteria are applicable to all sorts of study, universal, free, and simply adjustable.
CDISC stands for restoring clinical documentation's lack of standardization and promoting system integration. Although using CDISC standards is optional, regulatory agencies like the FDA strongly recommend it (United States Food and Drug Administration).
Automating Electronic Health Record (EHR) and Electronic Data Capture (EDC) Connectivity Using the OneSource Model
The way data is handled in clinical trials and in the healthcare industry differs significantly. Almost all information is stored digitally and is difficult for all parties to access.
The FDA and the University of California have joined forces to create a technique to automate data transfer from electronic records to EDC in an effort to solve this problem. Its name is OneSource, and it acts as a single repository for data from the ePRO, EHR, and EDC systems. This system gathers and presents data in accordance with CDISC, HL7, and FHIR, three clinical data standards.
The open-source development framework, OneSource, has already been employed by OpenClinica EDC. Any organization that has access to technical resources and a highly competent workforce is said to be able to harmonize to the same degree.
Modernization of legacy CTMS software
Many of these systems have not been upgraded since they were first introduced 20 years ago. The software frequently resides locally on a server, making it difficult for modern clinical research techniques to be supported. We can see two solutions to this issue.
#1 Change your workflow completely by switching to a new CTMS program.
#2 Upgrade your outdated software without worrying that it would significantly alter how your staff go about their daily lives.
The first strategy, though it may appear fairly radical and complex, is a strong long-term bet because the old software will only need more ongoing upkeep and sunk expenses as time goes on.
Also, keep in mind that custom software allows you to make personal changes/adjustments at any time, which is not always the case with ready-made solutions. As a result, redoing the entire solution is frequently the best option.
It would be beneficial if you did not put off making changes indefinitely, because developing an effective digital solution is an investment in your potential, and the sooner you get to it, the sooner you can reap the rich benefits that come with developing such a solution.
Why do we require CTMS?
CTMS implementation enables clinical research organizations to increase efficiency and achieve excellent results. CTMS enables you to:
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In clinical trials, improve the quality of patient care;
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Enhance research reports;
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Facilitate adherence to research billing regulations;
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Improve the management of research finances;
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Aids in adhering to research execution procedures and meeting deadlines and timelines.
We would like to emphasize and reiterate that CTMS is a critical tool for optimizing the clinical research process. Its value is critical not only for assisting businesses, but also for remaining in compliance with the government.
There is no longer a need to use multiple disparate document management systems and tools for research subject management, research compliance, reporting, research data collection, sponsor billing, research billing, and research administration. These legacy systems are extremely time-consuming to maintain and necessitate manual checks to ensure that documents are properly tracked and updated. Furthermore, reporting necessitates significant data reconciliation efforts.
Many aspects of research operations are implemented and managed by research teams and underlying researchers. As a result, the ability to effectively manage clinical trials is directly dependent on unit funding, resource availability, and management. The use of CTMS will simplify many aspects of the clinical research process, allowing for faster and better results.
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