The number of project tasks, documents, and processes that must be managed during the course of a clinical trial are overwhelming for even the most seasoned and prepared organizations. Clinical trial project management entails the coordination of all aspects of a clinical trial which significantly impact the time and cost taken to research and develop a drug or medical device. A clinical trial project manager coordinates all activities across the study team, organizes meetings and communications (including study start-up activities), maintenance to study close-outs by utilizing various tools to analyze and report up-to-date study status, patient enrollment, site information, deadlines, and milestones, as is also responsible for tracking information for use by regulatory for submissions.
Managing all of the many projects that arise during the life of a clinical trial can seem like an impossible task, even for experienced professionals who recognize that good clinical trial project management is essential if the clinical trial is to be conducted efficiently and economically. A clinical trial project management solution can help organizations accelerate their clinical trials and give them powerful tools that are designed to improve efficiency in clinical trial project management. MasterControl CQMS provides an integrated approach to clinical trial project management and the handling of vital information such as milestones, visits, status, etc.
The trial master file (TMF) is at the core of clinical trial project management. The TMF clinical trial project management capability of MasterControl CQMS allows a user to plan their TMF documents and tasks as a projects and provides automated task reminders and updates as tasks are executed and promoted through various lifecycles.
MasterControl CQMS provides essential tools for clinical trial project management that cannot be found in any other single solution, specifically:
- A sample project plan template based on the DIA Reference Model, the ultimate TMF standard. Using this model increases efficiency and provides a central location for all required TMF content.
- Integrated project tasks (i.e., documents, processes, etc.). When integrated and automated, quality tasks can be executed and closed out efficiently for increased compliance.
Site documentation and trial eligibility information from hundreds of sites for various clinical studies can create massive clinical trial project management headaches. With MasterControl's clinical trial management software system, each clinical site's information and documents can be linked, searched, and reported on. This information includes facilities, equipment, past trial participation, and audit history as well as site- and study- specific documents.
The MasterControl CQMS also eases clinical trial project management burdens because it provides mobile access to the system. External and mobile users can quickly access information critical to their roles (think: monitors, auditors, or investigators) and can also accelerate the flow of information and execution of clinical trial project management tasks, which reduces cycle times (i.e., reviews, approvals, and training).
Document Types, Metadata, and Taxonomy based on the Drug Information Association’s (DIA) Trial Master File (TMF) Reference Model
Workflows: Routes, Collaboration, and Electronic Signatures
Study Monitoring (Initiation, Intern & Closeout Monitoring), Protocol Deviation and Clinical CAPA Process Management
Study Information, Project and Timelines
Clinical Vendor Qualification (CRO, etc.)
Clinical Vendor Relationship Management
Site Information (Facilities, Equipment, Audit History) and Documentation
Investigator Site File (ISF) Management
Site Qualification and Risk Based Selection Criteria
Vendor, Study and Site Audit Management
Study Team, Partners/Vendors, Study Site Training
Risk based Configurable Study Training
Access Documents, Processes, Tasks, and Training Courses from tablets or smartphones.
Project Risk - Study Timeline, Tasks Overdue, Completion Percentage
Clinical Procedure - GCP Documentation, Patient Enrollment, Safety, Data Integrity, Product Accountability / Storage, CAPA/ Deviations (Volume, Frequency, Trends)
Vendors/Partners – Risk-based Vendor Qualification/Selection
Sites - Risk based study site Qualification / Selection
Audit - CRO and Site Audits: Violation, Finding, Deviations, Follow-up / Corrective Action
Training - Completed, Outstanding, Overdue