Call Today For A Demo. Offload The Overload: Clinical Trials Management System InfoEd Clinical Trials Software links trials to related protocols, grants, contracts, publications, conflict of interest information, and patents with a true clinical trial document management system.
Request a Demo. Investigators and Coordinators Easily create new protocols in only a few steps Record or link required approvals regulatory approvals, contracts, and more to speed study startup and site activation Track enrollment of participants and their progress throughout the trial Manage and share critical study documents with clinical study software Review accumulating trial data and safety information with our Clinical Trials Software Solutions Manage communication with research team members, monitors, participants, and others Track and manage financial activity associated with the trial using our Clinical Trial Data Software and Clinical Trial Design Software Administrators Report on clinical trials and related financial activity for multiple departments, investigators, trials, and participants Standardize processes across the research enterprise with Electronic Research Administration Software Audit trials to verify compliance with regulatory and institutional requirements.
Quickly configure role-based security to control access to sensitive trial and participant information. We know how to manage clinical trials efficiently and effectively. Automation simplifies processes for clinical studies, from study setup through to submission. It helps to speed studies up and to reduce human error by removing manual processes.
It makes it easier for companies to comply with regulatory standards and guidelines set out by regulatory authorities. Download Now: Free guide on how to increase trial efficiency with automated metadata management.
As discussed, a clinical metadata repository stores all your organizational standards in 1 place. Doing this means they are easily accessible and ready to use across all your studies. Automation improves clinical trial efficiency and means your submission will be of better quality. Fewer resources are needed, and costs are saved. Our off the shelf clinical trial automation software a nd clinical metadata repository is a fully integrated online platform for facilitating clinical trials.
In short, you can store metadata content and build studies quickly using automated workflows. Our clinical metadata repository has all the desired features such as impact analysis, change management, and governance that were discussed earlier. And it has the necessary automated processes needed to generate the study artifacts required to make a submission to the FDA. You can read our blog on How a clinical metadata repository can help with data quality. Or if you can find out about important considerations before choosing a clinical metadata repository.
The diagram below shows the Formedix platform integrating with other systems. It also shows the built-in automated processes on the right-hand side. Formedix makes it quick and easy to make all the different metadata formats you need. You can approve forms in Formedix before using an EDC system. You can decide later on which EDC system to use. You can just reuse your annotations. If you need to make changes, you can instantly preview them. Start by defining the mappings from your source data to your SDTM.
That way your study designs and datasets are always regulatory compliant. If you need to create a define. You can even generate define. Learn more about our visual define. The Formedix platform lets you integrate with 7 leading EDCs. You can design your studies with all the features of the EDC you work with. You can also use our API to integrate with your own internal systems. That means you can set up automatic processes to push source data into Formedix and trigger a conversion.
Then, pull the datasets back into your system from Formedix. If you want to find out a bit more about the Formedix clinical trial automation platform , you can set up a call or contact us to tell us what we can help with. Or you can book an online customized demo. That includes 6 hours of free training to get you started! Privacy Policy Terms of Service. Toggle navigation. How clinical trial software can be used to optimize clinical trials Aug 11, AM.
Contents Types of clinical trial software. The data generated during such a trial is humongous and extremely critical for its success. Managing this data through multiple spreadsheets and data centres is not only cumbersome but also prone to errors, which might negatively impact the findings of the trial. Clinical trial management software offers a centralised location for the entire data.
Not only is this data stored centrally, but it can also be accessed easily, shared, modified, and distributed amongst the teams working on the trial. This is even more beneficial when there are multiple studies going on at the same time. The data generated during a clinical trial, especially that pertaining to the patients, is extremely sensitive and confidential.
A clinical trial software ensures the security of this data by incorporating logins, user permissions, and assigning passwords to the files. This is cumbersome when one is managing multiple spreadsheets and data centres and leads to confusions and lack of communication. CTMS software ensures that all the finances pertaining to a clinical trial whether the sponsorship amount or the payments and receivables are accurately managed.
This is especially important when there are multiple sites involved in a particular clinical trial. The software creates a detailed and interactive schedule that breaks down the payments into logical subparts. This, in the long run, ensures better financial management and reducing any risks, which might occur making the trial more compliant to budgets and taxes. The research staff involved in a clinical trial at times gets pulled into administrative tasks that take away their precious time allocated for the research.
Clinical trial software ensures that all the processes are simplified, automated, and speeded up. The staff can focus more on patient care rather than being involved in the mundane administrative tasks. Investing in CTMS software is a huge financial decision for any clinical research organization.
Installing a clinical trial management software means an overall overhaul of the processes as well. Therefore, these factors should be considered critically before investing in this software:. For this, you need to define what are your actual objectives of investing in a CTMS software. Unless you are clear about your objectives you cannot invest in software optimised to fulfil those. You might be looking at objectives like simplifying the process, to reduce costs, securing your data etc.
Lay these down before purchasing the software. You need to assess if the software is easy to integrate into your existing systems, teams, and procedures.
If your end user i. Involve your teams in the purchase decision and let them experience a demo of the software. It will lead to fewer problems at a later stage. Once you purchase and install the software does the real challenge start. For a smooth transition and adoption of the software, it is important to have after-sale support from the provider of the software along with training material and sessions to make your teams comfortable with the software.
Will your clinical trial management software help manage my compliance needs? Is the system capable of managing site performance? Will the solution help define protocols along with their management? Does the system offer recruitment and monitoring of patients?
In what ways will the system simplify patient management? Does the software provide scheduling functionality, for instance, scheduling of patient visits?
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