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Clinical Trial Management Software – Addressing Industry Challenges

  • 15-16 min read
  • September 28, 2021
  • 👍 Rating — 5 (24 votes)

It’s no secret that companies that conduct clinical trials are not always in a hurry 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 Many of them still keep paper records and diaries, as well as outdated software that can be something like ten years old.

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 eliminate inconsistencies in information. This approach has dramatically improved the accuracy of the data used in clinical trials. Therefore demand sprung up for an integrated system that streamlines workflows and provides ease of use.

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 silver 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 too, which we will also talk about.

clinical trial software

What is a clinical trial management system?

Clinical Trial Management System (CTMS) is a software system used to manage clinical trials in medical organizations. CTMS serves 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 clinicians to set milestones and track progress, see each team’s performance, 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 in this area are outdated.

With the benefits that IT technology adds to clinical trials, CTMS should be available to every pharmaceutical and biotech laboratory. In case your healthcare organization wants to replace an existing system or develop a custom one, we want to give you 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, as well as challenges that may be encountered when implementing ready-made solutions and why custom ones may be more beneficial for you.

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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 are appearing on the market. Based on our experience in developing medical solutions, we want to talk about the main functions that should probably be included in CTMS and how they can give clinical trials a much-needed boost.


Investigator profile
A profile must be embedded in CTMS, it will typically contain some of the following pieces of information about the provider (name, address, 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 research participants. At the same time, this database is the basis for establishing healthy relationships.
Integration with the site
CTMS must provide visibility of different aspects of the research through the [web]site, allowing users to easily monitor the research process. They help in scheduling site visits by giving users the ability to view conversation history. 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.
Solution optimization for mobile devices
We know that most clinical research professionals are frequent travelers, and being able to comfortably work from their mobile devices is essential. However, many prefer web applications hosted in the cloud, the convenience of which is in the fact that these medical specialists are able to always remain in touch and have access to data from anywhere in the country or the world.
Acceptance of payments or donates
To maintain the effectiveness of research sites, CTMS must facilitate timely and accurate payments and manage contract terms effectively.
Deployment to the cloud
Early CTMS platforms were deployed locally and relied on object-oriented programming, offering little-to-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 and applications than ever before.
Resource management
The importance of assigning personnel to clinical trials based on skills, languages, availability, location, and experience cannot be overstated. 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.

clinical trials software integration

Examples of Clinical Trials Management Solutions

With demand for goods produced by life sciences and booming drug development pipelines, work processes and flows also get more complicated, busy, and in need of improvement or revamping. This is exactly where CTMS comes in. Software developers are continually striving to maximize capabilities offered within a single solution.

Nowadays, there are many such tools that can be purchased on the market. However, to save you time, we  took what we found to be 2 of the most popular ready-made solutions with somewhat different models; we are hoping this will clear some things up and help you understand which functions are more important for you and what you would like included in your custom development (we will later explain the advantages of this option vis-a-vis purchasing a subscription to a ready-made solution service):

#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 the software, you can simplify your workflow by integrating data entry automation and synchronization.

Another useful feature of this solution is real-time analytics, medical coding, and judicial proceedings. 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 the competition. Its scale can be changed depending on the requirements of your research. Also, no special equipment or infrastructure is needed to run/operate. This means a lower total cost of ownership and a more affordable, simple implementation and integration process for your research organization. The best part is that it can be used without much programming skills or know-how.

#2 MasterControl CQMS is a clinical trial management software solution designed to help life sciences organizations manage their documents, project tasks, ensure quality, keep track of audits, etc. It can increase efficiency by helping 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 possesses capabilities in areas such as quality assurance and risk management.

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

Reviews of ready-made CTMS applications

If you start looking for a CTMS solution on the web,  you will definitely get dozens of results of ready-made such apps intended for clinical trials with fairly similar characteristics, functionalities, and abilities. Despite their appealing interfaces and easy-to-use systems, it is unlikely that they are good enough to cover all crucial clinical trials activities and provide excellent oversight and control of those activities. As a result of our research on the reviews of popular CTMS apps like Castor, MainEDC, Research Manager, OpenClinica, we have prepared a list of the obvious and conspicuous disadvantages that are present in practically all third-party CTMS vendor solutions:

  • Limited functionality – this is the most common shortcoming of the ready-made solutions as the features they offer are not going to cover all needs and processes within a given organization;
  • A limitation on the number of users/participants allowed/accepted, meaning that the  solution is only scalable to a limited extent;
  • Few medical centers can be added to the system for exchanging clinical trials information;
  • Lack of storage and space to keep previous records leads to the inevitability of loss of vital documents and results of previous clinical trials;
  • Lack of automation and many things still need to be done manually;
  • A large number of bugs (as is often the case) cannot be fixed asap as the support team is not able to keep up with the volume of queries from all their subscribers/users.

Challenges of Clinical Trial Management 

Have you noticed that there are several overarching problems at every stage of the test? We can trace them back to three significant issue themes.

The process of drug research and development can take years. But the main problem is not even that, it’s that every year it becomes more expensive,  demanding and arduous. The amount of data being produced is growing so fast that it’s becoming increasingly difficult if not impossible to manage. Ramping up the amount of software to work with the data isn’t the best solution. Why? Read on to find out why.

Lack of unity. Based on today’s realities, research professionals have to work with a dozen different systems simultaneously, while in clinical trials an average of four different data sources is used. Data comes from everything starting with ePRO questionnaires and ending with specialized applications, wearables, electronic informed consent forms, etc. Analyzing all this data isn’t impossible, but it’s definitely 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 greater detail later on in this article.

Integration. Some technologies allow you to avoid mistakes in documents and deny access to duplicate sensitive data. Specialists are trained in technologies with varying intensity, and the variety of tools does not allow fully automating this process.

Problem-solving solutions for clinical trials

Any change can be difficult and often is, especially in a highly regulated area like clinical research. We can talk and hope to achieve some all-unifying 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 stands for making up for missing uniformity in clinical documents and pushing for integration between different systems. The use of CDISC standards is optional but highly encouraged by regulatory bodies such as the FDA (United States Food and Drug Administration).

Widen your knowledge about the standards in clinical trials from the report below.

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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 has partnered with the University of California to develop 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. 

OneSource is the public development framework that has already been used by OpenClinica EDC. It is argued that any organization with access to technical tools and a skilled team can achieve the same level of harmonization.

Modernization of legacy CTMS software

The introduction of these systems began 20 years ago, and many have not been updated since. The software is oftentimes located locally on a 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 software and entirely transform your workflow.

# 2 Upgrade your old software without worrying about experiencing significant changes in the daily routines of your employees.

The first approach, although seemingly quite radical and complicated, is a good bet for the long-term; as the old software is only going to require more continuous support and sunk costs at an increasing rate as time goes on. Also, do not forget that custom software gives you the option to make personal changes/adjustments at any moment, which is often not the case when it comes to ready-made solutions. Hence, redoing the whole solution can often be the best bet.

It would help if you did not postpone changes indefinitely, because an effective digital solution is an investment in your potential, and the sooner you get to it – the sooner you get to reap the rich benefits that come with developing such a solution.

Building a Clinical Trial Management System

Most of the existing apps offer only 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 a proprietary Clinical Trial Management Solution.

Since 2011, GBKSOFT builds and delivers custom software for different industries like healthcare, education, finance, manufacturing, retail, and others. Our team stays aware of the latest technology innovations being introduced into the healthcare industry, staying abreast of the most recent revolutionary technologies applied as part of digital transformation as we understand how groundbreaking technology is and how much more potential is still left in the field. 

Must-have Features that GBKSOFT adds to CTMS:

  • Payment processing system – PayPal and Stripe payment gateways added.
  • Custom Design – this is a must-have option if you want to build an efficient app as a consultant or service provider.
  • Chat – this feature enables direct dialog between stakeholders like patients, clinicians, scientists, which raises engagement and monetization rates of the app. We can add paid stickers and donation options, so users could opt to 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 load intensity and the number of drugs according to the heart rate data provided by smartwatches.
The development team
Business Analyst
Admin
Designer
HTML/CSS
Front-end
Back-end
QA

The average cost of the development of custom clinical trial management software starts from $80000-$100000 and varies depending on the range of specifications needed for your project.

Why do you need CTMS?

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

  • 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 work within deadlines and timelines.

Once again, we would like to stress and reiterate that CTMS is an essential tool for optimizing the clinical research process. Its value is of paramount importance not only in helping the business but also to be in compliance with 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 legacy systems are incredibly time-consuming to maintain and require manual checks to ensure that documents are properly tracked and updated. Additionally, reporting requires significant data reconciliation efforts.

Research teams and underlying researchers are responsible for implementing and managing many aspects of their research operations. As a result, the ability to effectively manage clinical trials directly depends on the unit funding, resource availability, and management. The implementation of CTMS will simplify many aspects of the clinical research process, allowing for faster and better results.

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FAQ

The eTMF system uses the same LS Clinical Trip Report File Transfer Web service to send or return the trip report. 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.
Clinical Trials Management System (CTMS) is a software system used to manage 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 set milestones and track progress, see how each team is doing, schedule thematic visits, manage relationships between different team members, control costs, and, of course, prepare reports.

Creator

Due to my Master`s Degree in journalism, I focus on the details while doing the research on the topic. My particular curiosity is about the latest mobile app developments that start in 2015 that make life easier and save much time to spend it more productive. I am an expert in reviewing and consulting web projects related to web applications, especially if they are connected with wearables.
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