Drug and medical device companies conduct clinical trials (also called interventional studies) during the product development process to ensure that their products are safe and effective. Clinical trial management is a costly, time-consuming process. If done poorly, it can result in the collection of inaccurate data that not only delays time to market, but also harms clinical study subjects. Not surprisingly, the life science industry is turning to technology to enhance the conduct of clinical trials, and to improve transparency into clinical study progress. By streamlining and fine-tuning the document management processes that can compromise data quality and participant safety, a proven CTMS software solution can help drug and device companies avoid regulatory noncompliance and accelerate time to market.
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On average, it takes about eight-and-a-half years to conduct a clinical trial. The amount of documentation, as well as processes and tasks, that must be executed and monitored as part of the clinical trial management process is voluminous. A paper-based or manual CTMS system further complicates this already overwhelming, lengthy process. In order to stay competitive, many drug and medical device companies are struggling to find ways to cut costs, save time, and increase efficiencies at each phase of the clinical trial. Implementing an automated or electronic CTMS software solution can be an invaluable first step toward realizing these important goals.
Much of the required clinical trial management documentation is identified by the International Conference on Harmonization (ICH), which has established several international standards of good clinical practice (GCP) for drug development. The E6 guideline, ICH Harmonized Tripartite Guideline: Guideline for Good Clinical Practice, is the ICH CTMS system standard that deals primarily with clinical research. It was based on FDA regulations 21 CFR 50 and 56 for clinical trials involving human subjects.
In a nutshell, the E6 guidance outlines a list of essential documents that are required throughout the lifespan of a clinical trial: before a clinical trial starts, during the trial, and after a clinical trial. This essential documentation is housed in the trial master file (TMF). The size and scope of the TMF varies, but most are hundreds to thousands of pages in length and contain every last bit of relevant data associated with a clinical trial. Because there are many contributors to the TMF, such as the trial sponsor, study investigators, medical writers, auditors, clinical research associates, and clinical research organizations (CROs), electronic CTMS software can help track and monitor the TMF's extensive data more effectively, and enable drug and device companies realize market potential more quickly.
Today, more than ever before, risk management is the cornerstone of any quality management system (QMS). Similarly, risk management is critical in ensuring quality in clinical research. When evaluating CTMS software, it's important to choose a clinical trial management solution that includes an effective risk management application. CTMS systems that lack this crucial application will expose your organization to increased noncompliance risks throughout the clinical trial process. While people often use the terms risk management and risk assessment interchangeably, they are not interchangeable.
Using highly robust reporting and analytic tools, MasterControl CTMS software can help medical device and pharmaceutical companies manage risk throughout the life of a clinical study. Users can quickly and easily monitor a TMF project's timelines, overdue tasks, and completion rate. In addition, users can manage risk with the help of reports that will show a site's investigator and site qualification, audit history, deviations, and more. For all of these reasons, MasterControl's CTMS system is viewed as an end-to-end clinical risk management solution, designed to enhance transparency and manage risk throughout the entire clinical trial process.
Clinical risk management is just one of the many hurdles one can encounter during a clinical trial, and, as such, is just one of the many features that must be included in an effective CTMS software solution. The MasterControl Clinical Suite can help you overcome all of the hurdles associated with clinical trial management by providing these important features and benefits:
Able to manage all of the documents, processes, tasks, training, and audits that must be administered and controlled throughout the clinical trial management process, the MasterControl Clinical Suite is a complete, highly robust CTMS software solution. In addition, MasterControl's solution has been designed to streamline and increase the reuse of information while simultaneously simplifying the tasks and processes that must to be executed during the lifespan of a clinical trial.
To learn more about CTMS software, feel free to contact MasterControl representative today.