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Clinical Trial Management Software

  • Rating — 5 (2 votes)
  • by Ksenija Kolomiiets
  • Updated on September 15, 2020
  • Read —
    13-14 minutes

It’s no secret that companies that conduct clinical trials are not always in a hurry to introduce technological innovations. Many of them still keep paper records and diaries, as well as ten-year-old software.

Over the past few years, there has been a positive trend with clinical trial companies, including software in their workflow. A recent study found that 64% of researchers have used digital health tools in their clinical trials, and 97% plan to use them in the next five years.

Before CTMS came along, industry participants were faced with different kinds of solutions that replaced this software’s functions. After starting work with the new solution, it was found that it helps to eliminate inconsistencies in information. This approach has dramatically improved the accuracy of the data used in clinical trials. Thus, the demand for an integrated system that streamlines workflows and provides ease of use has emerged.

The adopted technology that is used to automate clinical trials is called “eClinical.” Just as healthcare providers have their EHR software, life science researchers have electronic clinics. These include platforms that use electronic data collection (EDC) interactive voice response systems, randomization, and trial delivery systems that have eliminated the need to enter duplicate data in both solutions. It’s worth noting that clinical trial automation is not a magic bullet that can solve all problems, but rather a business tool that analyzes performance metrics and helps improve them. Do not forget that CTMS has its drawbacks, which we will also talk about.

What is a clinical trial management system?

Clinical Trials Management System (CTMS) is a software system used to manage clinical trials in clinical trials. This CTMS will serve as a single, centralized corporate web resource to support clinical trials across multiple sites.

In other words, CTMS is a project management tool that allows you to track progress and set milestones, see how each team is doing, schedule thematic visits, manage relationships between different team members, control costs, and of course, prepare reports.

It seems that CTMS can solve the problem of integration and consistency, as many modern solutions come with EDC support. Along with Oracle, Bioclinica, and Medidata, popular systems include Parexel MyTrials, Forte OnCore, and others. But many of these systems already in use in this area are outdated.

With the benefits that IT technology offers for clinical trials, CTMS should be available to every pharmaceutical and biotech laboratory. In case your organization wants to replace an existing system or develop a custom one, we want to give some ideas about what functions can be useful and what to look for when choosing software.

This article takes a closer look at several clinical trial management software currently available on the market. We also highlight their features and capabilities, and challenges that you may encounter when implementing ready-made solutions and why custom ones may be more beneficial for you.

Already have a CTMS and want to update it or to replace it?

Features To Look For In A Clinical Trials Management Software

If you are looking for the perfect CTMS, we have a few points to look out for. As we said, the demand for these systems is now relatively high, so more and more solutions of this type appear. Based on our experience in developing medical solutions, we want to talk about the main functions that should be looked for in CTMS, and how they can give clinical trials a much-needed boost.

  1. Investigator profile. A profile must be embedded in CTMS, which contains information about the user organization (name, addresses, licenses, degrees, therapeutic areas, and specialties). Currently, the profiles of investigators on these platforms focus on hiring and compliance tracking. This approach helps find partners with a higher level of coverage, who subsequently attract as research participants. At the same time, this database is the basis for establishing healthy relationships.
  2. Integration with the site. CTMS must provide visibility of different aspects of the research through the site, allowing users to monitor the research process. They help in scheduling a site visit by giving users the ability to view the history of conversations. These messages include monitoring and security letters, technical issues, launch documents, and payment requests. There should also be the integration of CTMS portals that store documentation and manage service levels using workflows.
  3. Solution optimization for mobile devices. We know that most clinical research professionals travel frequently, and working comfortably from mobile devices is essential. Many prefer web applications hosted in the cloud, in this case, the specialist always remains in touch and has access to data from anywhere in the country or the world.
  4. Work processes. With the involvement of the biotech and pharmaceutical sectors in risk-based processes, triggers have become requirements. By the way, displaying workflows is useful for creating interaction with the site and SEO in general.
  5. Acceptance of payments or donates. To maintain the effectiveness of research sites, CTMS must make accurate and timely payments and manage contract terms effectively. Even though researchers’ fees are in the background, it is still preferable to have it than the prospect of exchanging vast amounts of information between different platforms.
  6. Deployment to the cloud. Early CTMS platforms were deployed locally and relied on object-oriented programming, offering little or no scalability. Cloud solutions today offer not only the ability to scale but also many other useful features. They can be quickly deployed and used with numerous tools for both internal and external staff and partners. This allows users to use such systems in many more clinical scenarios than ever before.
  7. Resource management. The importance of assigning personnel to clinical trials based on skills, languages, availability, location, and experience cannot be overemphasized. They play a critical role in achieving goals at both the country and research levels. Recruitment efforts can be driven by resource allocation and demand forecasts.

You are ready to start digital transformation but not sure about features your solution should have?

Examples of Clinical Trials Management Solutions

With life sciences, organizations expanding their drug development workflows, CTMS has grown in importance. For this reason, software developers are continually striving to maximize capabilities within a single solution. Nowadays, there are many tools. For example, we took 2 of the most popular solutions, by the model to understand which functions are more important to you and what you would like in custom development:

#1 IBM Clinical Development is one of the most popular solutions because of its comprehensive CTMS functionality. This electronic data collection tool is hosted in the cloud and provides a complete overview of critical test data. It is worth noting that this software has modules for interaction with patients and tools for randomization and supply management of studies, which contributes to higher quality research. Thanks to it, you can simplify the workflow by integrating data to automate data entry and synchronization.

Another useful feature of this solution has is real-time analytics, medical coding, and adjudication. IBM Clinical Development also has a quality assurance and compliance module that validates your processes against industry guidelines.

The adaptability of IBM Clinical Development is what makes this software stand out from its competitors. Its scale can be changed depending on the requirements of your research. Also, no special equipment or infrastructure is required to operate. This means a lower total cost of ownership and a more affordable implementation process for your research organization. The best part is that it can be used without much programming skills.

#2 MasterControl CQMS is a clinical trial management solution designed to help life sciences organizations manage their documents, project tasks, quality management, audits, etc. It can increase efficiency by helping to optimize tasks and processes that are critical to any clinical trial. Unlike other CTMS, MasterControl Clinical Suite does not just focus on collecting information and documentation. It has capabilities such as quality and risk management.

Since the above solution has integration with the site, with its help, you can manage projects and communicate with suppliers, exchange documentation and cooperate with third parties, and much more.

Clinical Trials Challenges

Have you noticed that there are several common problems at every stage of the test? We can lead them to three significant issues.

The drug research and development process can take years. The main problem is that every year it becomes more expensive and more demanding. The amount of data produced is growing so fast that it cannot be managed. Increasing the amount of software to work with isn’t the best solution. Why? Read the next paragraph.

Lack of unity. Based on today’s realities, research should work with a dozen different systems simultaneously, while in clinical trials, an average of four data sources is used. Data comes from everything from ePRO questionnaires to specialized applications, wearables, electronic informed consent forms, etc. Analyzing data in this flow of information is possible, but very slow and challenging.

Recently, norms have been adopted to sequence clinical research documents and the standardization of data exchange. We will cover this topic in more detail below.

Integration. Some technologies allow you to avoid mistakes in documents and stop duplicating confidential data, but this has not diminished them. Specialists are trained in technologies with varying intensity, and the variety of tools does not allow fully automating this process.

Are there solutions to the problems of clinical trials?

Any change is often difficult, especially in a highly regulated area, such as clinical research. We can talk about some unity of software, but will research groups and sponsors accept them? Probably not. And yet there is a way out:

Adopting CDISC Clinical Data Standards

CDISC or Clinical Data Exchange Standards Consortium is a standards development organization supporting data exchange in clinical research. Their standards are universal, free, and easily customizable for all types of research.

CDISC allows for missing uniformity in clinical documents and integration between different systems.

The use of CDISC standards is optional but highly encouraged by regulatory bodies such as the FDA.

Automating EHR-EDC Connectivity Using the OneSource Model

There is a big difference between how data is processed in healthcare and clinical trials. Almost all information is digitally recorded and cannot be easily accessed by all parties.

To somehow address this issue, the FDA and the University of California have developed a method to automate data flow from electronic records to EDC. It is called OneSource and serves as a single source of data from ePRO, EHR, and EDC. This solution collates and displays information according to clinical data standards such as CDISC, HL7, and FHIR.

The OneSource development framework, with an example implementation using OpenClinica EDC, is in the public domain. It is argued that any organization with access to technical tools and a skilled team can achieve the same harmonization level.

Modernization of legacy CTMS software

The introduction of these systems began 20 years ago, and many have not yet been updated. The software is located locally on the server, and it is tough for it to support modern clinical research processes. We see two ways to solve this problem.

# 1 Transition to an entirely new CTMS and transformation of the workflow.

# 2 Upgrading old software without significant changes in daily routine.

The first approach, although it looks quite radical and seems complicated, in the future, the old software will still require more support and costs. Also, do not forget that custom software allows you to make personal changes that are often not available in ready-made solutions. It would be best if you again shut down the entire enterprise. 

It would help if you did not postpone changes indefinitely, because, first of all, an effective digital solution is an investment in your potential.

Building a Clinical Trial Management System

Most of the existing apps provide a limited set of functions. In the existing apps, you may find limited features and, most importantly, no customization options. Because of these reasons our clients asked us to develop proprietary live-streaming apps.

Features GBKSOFT adds to CTMS:

  • Payment processing system – PayPal and Stripe payment gateways added.
  • Custom Design – This is a must option if you want to build an efficient app as a consultant or service provider.
  • Chat – This feature enables direct dialog between people and scientists, which rises engagement and monetization rates of the app. We can add paid stickers and donates options, so users could support the clinical trials.
  • Connection to Wearables – The client asked us to add this feature to track the health indicators of the people under study. Using this feature the scientist can adjust the intensity of load intensity and a number of drugs according to the heart rate data provided by smartwatches.

At first glance, the development of CTMS seems to require a lot of resources and time. But there is always a way to minimize those expenses.

For instance, we utilize external frameworks and services to streamline the development process. Usually, we use PHP programming language and framework yii2 for backend, js, angular for the frontend but there can be any other SDK.

This is a rough estimate. Actual developer rates can be checked in our manager and compare with prices in other regions.

Why do you need CTMS?

Implementation of CTMS allows clinical research organizations to increase efficiency and achieve high results. CTMS allows:

  • Improve the quality of patient care in clinical trials.
  • Improve research reports.
  • Facilitate compliance with research billing rules.
  • Optimize research finance management.
  • Helps adhere to research execution procedures and timing.

Once again, we note that CTMS is an essential tool for optimizing the clinical research process. Its value is of paramount importance not only in good practice but also in its obligations to the government.

No longer 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 systems are incredibly time-consuming to maintain and require manual checks to ensure that documents are properly tracked and updated. Also, reporting requires significant data reconciliation efforts.

Researchers and their research teams are responsible for implementing and managing many aspects of their research operations. As a result, the ability to effectively manage clinical trials depends on the unit depending on funding and resource availability.

The implementation of CTMS will simplify many aspects of the clinical research process, allowing for faster and better results.

The eTMF system uses the same LS Clinical Trip Report File Transfer Web service to send or return the trip report file received to date and URL link (to where the trip report file is stored) from eTMF back to CTMS. CTMS uses the trip report file URL link to open and review the trip report file as required.
The study is defined as the date the study subject has been registered to the study after having completed the eligibility step and has received a subject ID from the sponsor. The On Study date is the required date in OnCore for accrual credit. It is not related to billing. In the CTMS workflow, subjects will be marked as Billing Active in Epic as soon as they have consented to the study and have a consented date recorded in OnCore. What is CTMS?
Clinical Trials Management System (CTMS) is a software system used to manage clinical trials in clinical trials. This CTMS will serve as a single, centralized corporate web resource to support clinical trials across multiple sites. In other words, CTMS is a project management tool that allows you to track progress and set milestones, see how each team is doing, schedule thematic visits, manage relationships between different team members, control costs, and of course, prepare reports.

Need a consultation about CTMS custom development?

 

Ksenija Kolomiiets Expert & Evangelist in business optimization tools like fintech, logistics, on-demand services apps who will help you to understand the core ideas of the outlined themes by my articles. I also have great expertise in social media and education platforms so let me know "in comments" if you want me to describe a theme you're interested in.

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