Clinical trials are the first milestone researchers need to overcome on their journey to success. In order to achieve statistically valid results, experts rely on rich databases and a huge number of participants. In these vast labyrinths of abundant scientific information, experts need good documentation practices for their clinical trials.
Therefore, it’s not surprising that clinical trial management system or CTMS is needed. CTMS is a software program that helps researchers manage their data, create databases and design user interfaces for both clinical trials and studies (Muller et al., 2017). CTMS helps you manage your data. CTMS helps institutions collect data easily, manage studies in real time, obtain individuals sets of information, and provide a working interface that can be accessed by other organizations.
CTMS guarantees quick results. What’s more, CTMS helps you accelerate processes, such as import and export of data, and link information with charts and images.
CTMS is accessible. CTMS helps you manage (view, edit, delete) the information collected and make it more integrated. The best aspect is that CTMS gives you access to your data at all times. Having accessible databases is important not only for your current research but for any future or related study that can expand on the topic and lead to practical improvements in patients’ lives.
CTMS links research ideas. Data can be interconnected. In fact, CTMS can be used by any organization: from pharmaceutical giants to small start-up companies.
CTMS helps you look to the future. Sophisticated programs like Qolty take your research a step forward because they are way more elaborated that Excel tables, and at the same time, they can be operated by people without any IT knowledge.
CTMS is designed according to the international ethical principle of research. CTMS like Qolty support researchers when they need to deal with the strict ethical principles scientific research follows, which may vary across countries.
CTMS means safety. Even stored on the cloud, CTMS implement security and confidentiality as two main factors of operation.Conventionally, these assessments were administered through paper and pen method used in combination with pagers or electronic wristwatches (Delespaul et al. 1995). With the advancement in technology, electronic devices (PDA’s), and smartphone apps such as Qolty surpassed the traditional pen and paper technique. The surveys are usually short and completed within 1 to 2 minutes. The items are designed for prompt and easy data collection which usually comprise of open-ended questions, checklists or self-report Likert scales, and visual analog scales (Csikszentmihalyi et al. 2013).Advanced CTMS, such as Qolty, can help you take your clinical trials and studies to success.
3.1. Data Architecture
Qolty gives you access to a huge amount of data. As mentioned earlier, CTMS helps institutions collect and manage data easily.
Based on your requirements, you can access profiles of participants that could eventually enroll in your study. What’s more, you have real-time access all the time. Having access to information that’s not tied to a specific study is crucial as it gives researchers flexibility, while at the same time, it offers the opportunity to save valuable time and cut costs.
For instance, core Qolty helps you enter and view data in no time. Most of all, this CTMS helps you manage your data. All data fields are stored in nodes/forms, which allows you enter and access data in various formats, such as text fields and drop downs. Thus, even people who are not so tech-savvy can use Qolty and operate data, which is much easier when compared to MS tables.
Usually, such nodes of information are stored in containers that can help you build more complex entities, based on programmed processes. When we talk about more complex operations, we mean combining patient’s data with automatic actions, such as functions “if-this-then-that” base. Seeing the bigger picture can only facilitate research.
The good news is that nodes can be tied to other nodes, and even forms collected from different studies can be linked together. Thus, information doesn’t float isolated in the mist of research findings, and actions and consequences can be easily explored.
As we know, entering data might become a tiring process marked by mistakes and missing answers. In order to resolve such issues, another unique feature Qolty offers is that the program eliminates mistakes and human errors. How? Usually, using codes instead of diagnoses can facilitate data collection, entry, and export. You don’t need to type ‘blood pressure’ thousands of times, for example, but simply can enter a code or a numeric value. An option that prevents typos or some other mistakes can also be implemented. For instance, the system may not let you enter an age of participants over 100. Having clear data supports meaningful results.
3.3. Multi-center approach and meta-analysis
There’s one thing that is even better than accessing and using data easily: multi-center approach and meta-analysis. In other words, Qolty and its databases provide examiners the chance to merge information from different studies and use the combined information for further analysis. Let’s say that two separate studies have collected information on people’s alcohol use. With Qolty, all these cases can be combined, compared, and used within clinical settings.
On top of that, data can be used in multiple clinical settings, which helps not only research within a specific institution, but a cross-institutional meta-analysis and multi-center approaches. Now let’s focus on this unique feature: multi-center approach. Usually, different studies are managed by different experts. Even if many institutions use the same data provided by Qolty, researchers still can have different levels of access and permission rights. Thus, independent studies and their administrators can collect and manage data, while at the same time other study centers can benefit from their findings, view data and use it (for instance, as automated clinical reports).
Another important aspect of CTMS like Qolty is the so-called plug-ins. When it comes to huge sets of information used across multiple environments, plug-in settings help you manage your data. Plug-ins can be used to import/export information, such as medical reports, patient’s information data, PDF’s or even replace it with graphs and images. What’s more, Qolty is compatible with programs and suppliers of health information technology solutions and services, such as Cerner and Epic, so charts and graphs might be linked to the data collected. Having good visuals can help you structure and analyze your data as well as present it in front of other institutions and bodies.
Although CTMS sound appealing, many researchers fear their hard to implement features plus their bureaucratic side. Well, Qolty is a unique example of CTMS because its structure and architecture give researchers not only a wide access to information but an easy to use platform. All that is combined with an interactive interface. Even non-technical individuals can use the database and its hundreds of advanced modules, such as NIH PROMIS and Geofencing. With the ability to collect subjective and objective data, via ESM and phone sensors, respectively, Qolty strengthens the connection between users and researchers.
As mentioned above, Qolty surprises with its wide variety of modules. Some of the options researchers can choose from are NIH Toolbox, Neuropsychometric Surveys, Symptom Journals, and Private Labeling. Such methods have been used in many studies that use Qolty to improve patients’ health and take a meaningful decision regarding treatment and outcome. For instance, Children’s Hospital Los Angeles utilized Qolty to monitor weight loss in an obese pediatric population. As this problem is a health concern worldwide, with Qolty, other institutions can use the data collected and expand their research.
Here’s the right time to mention another module researchers and participants approve of: the wide use of Qolty to collect data across multiple medical settings. As a subcontractor for EHR Access to Seamless Integration of PROMIS (EASI-PRO), researchers can use Qolty to collect data by asking only relevant questions, which makes questionnaires shorter. By reducing questions, researchers reduce the cognitive load and emotional burden participants may experience, which is a great motivator for the completion of clinical trials. Thus, collecting data for clinical trials is more than easy.
3.7. Appealing Design and Notifications
Let’s not forget that CTMS is appealing and may take your research to the future. As a sophisticated and interactive program, Qolty takes an advantage of technology and apps, in particular. All you and your participants need to provide, collect and manage data for a clinical trial is a mobile device. With the advanced implementation of push notifications, via SMS and emails, surveys and reports are easily being noticed and complied with in a timely manner. With its advanced tech feature, researchers can track new entries and analysis data. Thus, surveys and tests are not burdensome but appealing and easy to manage. As mentioned earlier, the data collected is available at all times.
3.8. Digital Consent & Security
Qolty is an advanced CTMS, which resolves all the ethical dilemmas that may appear. As mentioned above, security and personal data should be confidential and protected, so consent forms are needed before any research endeavor. Qolty eliminates any potential problems because consent forms and “in-fight” consent waiting for a signature are included. Also, you can manage who can view and access your database. As described above, you can provide different permission rights within your research team or any multi-center approach. Usually, the administrator has full access to view, edit, and delete sets of information and forms; while other researchers or members of the team can have only assisting functions. For instance, assistants may be allowed to enter data only, while other organizations may be allowed simply to view data in order to support their research and enrich their database.
Most of all, the information stored in Qolty is completely secure. As Qolty offers a HIPAA secure way, the program provides a cloud-hosted version of the CTMS, and also, a self-hosted version of the software. Note that in both cases safety is guaranteed and control of data is only in your hands.Clinical trials are one of the major steps of each research journey. Although hypotheses and ideas might be overwhelming, science and research need practical backup, data, and real-life focus. Therefore, CTMS is a crucial aspect of research and clinical trials, in particular. CTMS gives researchers the unique opportunity to collect, store, and analyze data. With easy to manage fields and sets, organizations can collaborate and merge information in order to improve patients’ health. From research on smoking cessation to studies on heart rates, CTMS gives a structure to the wide variety of information. Most of all, this data is available and safe all the time.
While other clinical trial management systems are hard to implement and time-consuming when it comes to training of researchers and participants, Qolty is an easy to use and implement software program. It makes clinical trials more efficient and cost-effective. To be more precise, Qolty gives researchers the unique advantage to implement technology and smartphones when storing and documenting information, which can lead to high levels of engagement. As mentioned above, many Qolty modules give the chance to conduct time-saving surveys and tests, which leads to high levels of user engagement and motivation. On top of that, with its digital consent option and security plans, the use of Qolty resolves all possible ethical and confidential issues that may appear during the study.
Let’s not forget that CTMS and their meta-analysis functions can help research and push scientific knowledge forward – with the sole purpose of improving patients’ well-being and modernizing medical settings. In the end, that’s all that matters.Müller, J., Heiss, K., & Oberhoffer, R. (2017). Implementation of an open adoption research data management system for clinical studies. BMS Research Notes.