If you are a sponsor or a CRO that conducts clinical research for a sponsor, then you know how critical clinical quality management can be in your race to be first to market. On the average, it takes at least eight-and-a-half years to conduct a clinical trial. The stopwatch is ticking and every week that you are behind schedule means another week of additional cost and unrealized market potential, while giving your competition a chance to catch you in the turn.
From the day pre-trial planning begins, all the way to clinical trial closeout, the challenges can be overwhelming. There is tremendous documentation, document exchange, and coordination required involving investigators, clinical research associates, medical writers, and auditors or monitors. Investigators and support staff need to be trained on an ongoing basis and clinical trial sites have to be monitored closely. All stakeholders must do their part to comply with GCP regulations. All of these pressures can make clinical research seem like a formidable obstacle course. But with the right clinical quality management software, it doesn't have to be.
The MasterControl Clinical Suite™ is a complete clinical quality management solution designed to streamline your processes by managing all documents, tasks, processes, training, relationships, and audits throughout the clinical trial. The suite includes MasterControl Reference Model-TMF JumpStart, based on the DIA TMF Reference Model, which is an industry best practice standard for ensuring completeness of clinical trial documentation. It provides a single, web-based location for all TMF documents, making search and retrieval of documents easier.
The right clinical management software systems can make all the difference between a smooth-sailing clinical study and an obstacle-riddled clinical trial. The MasterControl Clinical Suite can help you increase efficiency, ensure compliance, and accelerate getting to market. It can help you in the following areas:
TMF Document Management: The MasterControl Reference Model-TMF JumpStart, based on the Drug Information Association's (DIA) Trial Master File (TMF) Reference Model, provides a centralized location for all TMF documents. It will help boost user productivity by:
TMF Project Management: MasterControl's clinical quality management system uses a Project Plan template based on the DIA TMF Reference Model and allows management of TMF documents and tasks as a project, providing automatic task reminders and updates when tasks are executed. Tasks can be scheduled together as a group. Dependencies between individual tasks and groups of tasks can be created. Each clinical trial site's information (facilities, equipment, past trial participation, audit history) can be linked, searched, and reported on.
Clinical Site Management: Robust clinical management software systems have the capability to manage site-specific documents. MasterControl's clinical quality management system does exactly that - it manages information pertaining to study site selection criteria (location, specialty, facility type, study phase capability) and site capabilities (facilities and equipment), as well as investigator documentation and IRB documentation. It streamlines document exchange among investigators, trial site support staff, sponsor, CRO, and CMO.
Clinical Processes Management: MasterControl's clinical quality management solution streamlines deviation, CAPA, and other processes critical to GCP compliance throughout the life of a clinical trial. It offers flexibility in creating forms and checklists for managing GCP processes.
GCP Audit: Monitoring of internal and external procedures through audits is critical in making sure that study results are accurate. Study procedures, patient recruitment requirements, and data entry in case report forms and visit reports all have to be monitored. With MasterControl's clinical quality management system, scheduling audits and assigning audit-related tasks will be automated so nothing will be overlooked.
GCP Training: Choose clinical management software systems that can support ongoing training for investigators, related staff, CRAs, and partners. With MasterControl, ongoing training is easier because it streamlines the execution of training, including notification of training tasks, dissemination of training materials (documents, audio, video), and testing. It offers configurable questionnaire, test, and quiz setup.
Clinical Risk Management: MasterControl's clinical quality management system manages risk throughout the life of a clinical trial with integrated risk management tools such as reporting and analytics. For example, users can monitor a TMF project's timelines, overdue tasks, and completion rate. Similarly, users can manage risk with the help of reports and analytics that will show a site's investigator and site qualification, audit history, scorecard, violations, deviations, etc.
Mobile Access: A user can access documents, tasks, and processes in the MasterControl clinical quality management system with a tablet or a smartphone. This capability can be particularly helpful to investigators, CRAs, and other team members who need access to SOPs and other critical study documents while working on site.
Access for Partners: MasterControl GuestConnect provides a means for document exchange and collaboration with outside partners (CRO, CMO), allowing notifications, task assignments, and redlining capabilities.
Select clinical management software systems that will ensure GCP compliance and streamline your processes for a smooth-sailing clinical trial. MasterControl provides:
Complete Clinical Solution: Manages all clinical research documents and tasks and connects all critical processes.
Industry Best Practice Standard: MasterControl's Reference Model-TMF JumpStart is based on the DIA TMF Reference Model, an industry best practice standard for ensuring completeness of clinical trial documentation.
Easy-to-Implement Solution: Many clinical research staffers are familiar with the DIA TMF Reference Model, making implementation of MasterControl's clinical quality management system faster and easier.
Mobile Access: Ability to access information and perform tasks using a tablet or a smartphone will help boost overall efficiency and productivity.
For more information about how MasterControl's integrated software solutions can help with clinical quality management, please feel free to contact a MasterControl representative.