Medical Writing. Medical Writing Support for Thought Leadership. Learn More with These Resources. Newsletter The Rapid Pace of Regulatory Change Read our June of edition of our Newsletter, Voyager, which provides insights on the value a Veristat partnership delivers to overcome the regulatory hurdles that Get Updates. Here are our picks:. Offering a unified cloud-based electronic data capture tool that provides a degree view of critical trial data, this platform is built to help you enhance your research workflow.
It also comes with patient engagement modules as well as randomization and trial supply management tools to help you execute your clinical studies as smoothly as possible. To further streamline your workflow, it also comes with data integration so you can automate data input and synchronization. Among its other notable functionalities real-time analytics, medical coding, and endpoint adjudication.
IBM Clinical Development also has a quality control and compliance management module to help you make sure that your processes adhere to industry regulations. Lastly, another aspect of IBM Clinical Development that made it one of the leading systems in the industry is its adaptability.
This means lower total cost of ownership and a more affordable implementation process for your research organization. Moreover, it can easily be used even without prior programming experience. For more information about their basic and enterprise pricing plans, you may simply get in touch with their vendors.
Edge CTMS by Medidata is a robust cloud-based application created to streamline all aspects of research management from budgeting to evaluation. Ideal for businesses of all sizes, it leverages agile development methodology in order to help you maintain a steady pace in your clinical research even in the event of unforeseen circumstances.
With it, you can easily evaluate the effectiveness of your processes as well as make modifications to your workflow with minimal disruption to your operations. The platform also integrates with Rave EDC so you can monitor the real-time status of your research progress. As for data management, Edge CTMS has an open architecture that lets it exchange data with other business systems as effortlessly as possible.
Like the other top solutions we will be discussing, Edge CTMS comes with a complete study management module and payment module so you can manage both the business and research aspect of your operations in one hub. What makes it different is that all of these functionalities can function individually or simultaneously, allowing it to adapt to your needs.
To get a quote, be sure to get in touch with the vendor for more details. MasterControl CQMS is a clinical trials management solution that is designed to help life science organizations manage their documents, project tasks, activities, quality events, audits and training, to name a few. It is capable of boosting efficiencies and allows for data reuse while helping streamline tasks and processes that are critical to any clinical trial.
It has capabilities such as quality and risk management. Other prominent features include study, site, project and vendor management, electronic trial master file management, document exchange and third-party collaboration, among many others.
These and more make up the reasons why the platform is trusted by over 1, organizations worldwide. You have to visit its website to request for a customized quote. EXPeRT eClinical is a clinical trial management platform that is targeted at organizations who are looking to improve their trial processes.
The software significantly speeds up time-to-market with the use of real time analytics, trial management, risk management and business intelligence. It provides users with visibility over all aspects of clinical trials by integrating all relevant clinical and operational data.
The solution also has the ability to manage risk, allowing you to confidently get on with your trials by providing access to trial performance in real time. Collaboration among stakeholders, sponsors and CRO are also promoted with the shared visibility that the system provides. Whereas your average CTMS takes a silo approach in risk management, which results in efficiencies and additional costs, EXPeRT eClinical does this in real time, offering protection and total control over trials. You can contact the vendor directly and ask for a quote.
BioClinica CTMS is a web-based clinical trial management solution that has the ability to transform clinical trials into a highly-efficient work environment. The system offers users total control over trials, bringing efficiency and quality information to any scientific study. It likewise provides real time operational visibility. The platform can link trials to data using Outlook quite easily, promote collaboration using SharePoint and export information to Excel.
These data exchanges are seamlessly accomplished, making Bioclinica one of the most powerful solutions of its kind. Even novice users require minimal training in using the system as all interactions occur in Microsoft tools, which just about everyone is familiar with.
BioClinica pricing information are only available upon request. You can contact the vendor for a price quote. Equipped with data capture, electronic CRF, automated data querying, and data validation, this platform will surely help you make your clinical studies more accurate and efficient than ever.
It even has an intuitive user interface that makes it easy to learn and implement even for research professionals who do not have extensive technical know-how. What truly makes Ofni Clinical stand out, however, is that it can match your case report forms. This makes it highly adaptable to your existing workflows. It even has strict data cleaning, data validation, and edit check functionalities so you can identify any questionable data entry that may negatively affect the results of your study.
Ofni Clinical offers a quote-based plan for its users to ensure that they are only paying for the CTMS tools they require. For more information, contact the vendor. It quantifies cognitive performance and impairment in a non-invasive manner in order to help you manage cerebral health as effectively as possible. With it, you get access to language-independent parallel modes and stimuli randomization so you can yield more accurate evaluations regardless of what language your subjects speak.
It leverages computerization and automation to administer and score tests. After which it syncs your data in a centralized database. It even backs up your data regularly to ensure research continuity. For more details, be sure to get in touch with their representatives. OpenClinica is an open-source clinical data management and electronic data capture system.
It comes with an easy-to-use drag-and-drop interface that lets you design studies, perform real-time edit checks, as well as manage supplies at a granular level. OpenClinica is also intuitive enough to help you drill down into your study data.
It has extensive data visualization tools that let you format results using bar charts, line graphs, or any other graphic that you prefer. It also allows you to create advanced queries so it is easier to review findings as well as correct errors quickly. OpenClinica offers four different plans depending on the kinds of feature sets you require.
The OpenClinica Community package is available for free while the Enterprise, Participate, and Randomize plans are all available by quote. Clinical trial management software Clinical Research IO helps members of the life sciences sector in managing all aspects of their trials.
It can handle just about everything, be it curating your patient database, tracking your finances or integrating your operations with the solution.
Scheduling is no problem with the platform, letting users schedule subject visits and change calendar entries using subject profiles as basis. If those methods are used, reviewing documentation and data can be done beforehand. Remote access to that information is also useful when it comes to writing the report after the visit.
An important component of preparing is to look at past monitoring reports and audit reports, if any have been conducted. If a previous site interim visit reported a problem, that requires follow-up during the next visit. Time on-site is limited, so these issues should be prioritized. A risk-based approach to monitoring will also indicate certain areas that require precedent.
The monitoring report template should be open throughout the visit, both to keep you on track and to give you a place to write notes. Everyone has their own system of taking notes, but your focus should be on the areas most important to regulators — patient safety and data quality. This is the whole reason for doing the site monitoring, so take notes that demonstrate adherence to protocol, good clinical practices GCP , and regulations.
Or notes on how the site is not adhering to those requirements. They will be shaped by previous visits and affect future ones. Hopefully, issues from the past site monitoring reports that you reviewed while preparing for the visit have been resolved. If not, include it in your notes and the final report.
Any corrective action the site has implemented should prevent recurrence. The site and monitor should work together to find solutions that will bring the site into compliance. Your report should also include any items that will need follow-up during the next visit. Besides follow-up for a single site, monitors should also be aware of how any issues might reflect a trend across the whole study. If multiple sites are having the same issue, it might have more to do with the study protocol than the sites themselves.
Or you might look back at your notes later and realize something that made sense in the moment no longer does.
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