How CTMS Software Helps Manage Clinical Trial Documentation
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.
Risk Management and Why It Must be Included in Your CTMS Software Solution
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.
- Risk Management: As it relates to clinical research, risk management is defined as the overall process to manage risk to an acceptable level throughout a clinical study. It's comprised of four phases: assessing risks, deciding what to do about the risks, implementing risk controls, and measuring the effectiveness of those controls. Risk management is an ongoing process, but it is typically re-started at intervals to refresh the data in each stage of the clinical trial management process.
- Risk Assessment: Risk assessment is defined as the process to identify and prioritize risks. Essentially, it is a viewed as an individual process within the larger risk management cycle. Unlike risk management, which is on-going and often tied to other processes, risk assessment tends to be applied on an "as needed" basis.
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.
Overcoming Clinical Trial Management Hurdles with MasterControl's CTMS Software
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:
- Trial Master Folder (TMF) Document Management: Unlike other CTMS systems on the market, MasterControl includes the Reference Model-TMF JumpStart. Like all MasterControl solutions, the Reference Model - TMF Jumpstart is based on industry best practices - specifically the Drug Information Association's (DIA) Trial Master File (TMF) Reference Model. It provides a central, web-based location for all TMF documents which, in turn, makes searching for, retrieving, and tracking documents much easier. And because many clinical research staffers are familiar with the DIA TMF Reference Model, user adaption and ease of implementation is increased.
- Trial Master Folder (TMF) Project Management: Because MasterControl clinical trial management software uses a Project Plan template, which is also based on the DIA Trial Master Folder (TMF) Reference Model, essential TMF documents and tasks can be managed as a project. This is a critical CTMS software feature; it provides automatic task reminders and updates when tasks are executed. In addition, it allows tasks to be scheduled together as a group. This is helpful because it allows for the creation of dependencies between individual tasks and groups of task, and it also links the information of one clinical trial site to other sponsor sites.
- Clinical Site Management: Clinical site management is crucial to any good CTMS system. Fortunately, MasterControl is able to manage site-specific documents, which can include site qualification, protocol amendments, and study updates. In addition to investigator documentation and internal review board (IRB) documentation, MasterControl's CTMS software manages information pertaining to study site selection criteria (location, specialty, facility type, etc.) and site capabilities.
- Clinical Processes Management: Like risk management, CAPA (corrective action and preventive action) management is also critical to effective CTMS system management. MasterControl clinical trial management software streamlines deviation, CAPA, and other processes that are critical to GCP compliance throughout the lifespan of a clinical trial. And in terms of creating forms and checklists for managing GCP processes, MasterControl is unmatched.
- GCP Training: MasterControl's training management capabilities further set its CTMS software apart from other clinical trial systems on the market today. MasterControl streamlines the execution of training, this includes the notification of training tasks, dissemination of training materials (documents, audio, video), and testing. It offers configurable questionnaire, test, and quiz setup.
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.
Contact Master Control for Information on CTMS Software
To learn more about CTMS software, feel free to contact MasterControl representative today.