cGCP Software Systems

MasterControl cGCP Software Systems are Designed to Help Companies Maintain Compliance and Streamline Clinical Processes

According to the U.S. Food and Drug Administration (FDA), the observance of current good clinical practices (cGCPs) - including adequate human subject protection (HSP) - is a critical requirement when conducting any research that involves human subjects. In fact, FDA regulations for conducting clinical trials have emphasized both cGCP and HSP for more than three decades. Consequently, many countries have officially adopted cGCP standards as their principal guidelines. The cGCP software systems currently available on the market can be indispensable tools for helping organizations better manage clinical processes according to regulatory guidelines.

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In their efforts to maintain compliance with cGCPs, companies face innumerable challenges in controlling and managing critical documents during clinical phases. MasterControl cGCP software systems help life sciences companies meet compliance requirements by helping them:

  • Achieve compliance with cGCPs and maintain compliance year after year
  • Manage quality activities across the GCPs
  • Integrate compliance into corporate culture so that each department across the enterprise is aware of and able to meet compliance standards
  • Connect people with appropriate clinical data and processes
  • Meet the challenges of GCP multi-site study requirements
  • Manage clinical trial site information including data from institutional review boards (IRBs)
  • Handle process-based inspections and related information

Features and Benefits of MasterControl's cGCP Software Systems

  • A Complete cGCP Software Solution: A clinical trial involves a variety of documents, tasks, and processes that often share common information and may be interdependent. MasterControl’s integrated modules increase reuse and efficiency throughout clinical trial processes.
  • Industry-recognized Best Practices: The Drug Information Association Trial Master File (DIA TMF) Reference Model has been adopted as an industry best practice standard for ensuring documentation completeness for a clinical trial from resources both internal and external to an organization. To facilitate compliance with these best practices, MasterControl includes preconfigured forms based on the DIA TMF Reference Model.
  • Simple Implementation: Since employees may already be familiar with the DIA TMF Reference Model, using MasterControl's Reference Model JumpStart configuration decreases implementation time, ensures that companies get a standardized configuration, and reduces potential learning curves.
  • Risk Management: MasterControl is a comprehensive cGCP software system in that it features risk management functionality designed to enhance transparency and manage risk throughout the life of a clinical trial.
  • Mobile Access: External light users and mobile users can quickly access information critical to their roles (whether they are a monitor, auditor, or investigator) and accelerate the flow of information and the execution of tasks. In so doing the organization is also able to reduce cycle times (i.e., reviews, approvals, training, etc.).

MasterControl cGCP Solutions

MasterControl cGCP software systems provide proven solutions for:

eTMF Management

  • Project Plan Template based on the DIA TMF Reference Model
  • Manage, assign, and launch TMF artifact tasks to internal and external users

TMF Document Management - Document Management

  • 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
  • Clinical Monitoring and Clinical Quality Events Management - Site Management & Site Monitoring Visit Templates: Site Initiation, Site Interim, and Site Closeout
  • Clinical Quality: Protocol Deviation & Clinical CAPA

Clinical Site Management - Site Qualification and Relationship Management

  • Site Information (Facilities, Equipment, Audit History) and Documentation

Clinical Vendor Management

  • Manage vendor qualification, vendor documents, vendor audits, past history and relationships

GCP Audit - Audits

  • Clinical Site and Partner (i.e., CRO, CMO) Audits

GCP Training - Employee, Partner, and Investigator Training

  • Configurable Test/Quiz Setup

Clinical Risk Management

  • Project Risk - Study Timeline, Tasks Overdue, Completion %
  • Clinical Procedure - GCP Documentation, Patient Enrollment, Safety, Data Integrity, Product Accountability / Storage, CAPA/Deviations (Volume, Frequency, Trends)
  • Site Management - Investigator Selection / Site Qualification, Audit History, Deviations
  • Audit - CRO & Site Audits: Violation, Finding, Deviations, Follow-up / Corrective Action
  • Training - Completed, Outstanding, Overdue

Mobile Access

  • Access documents, processes, tasks, and training courses from tablets or smartphones.

MasterControl's cGCP Software Offers Real Solutions to Real Clinical Challenges

Some of the many pains of managing clinical processes that can be alleviated through the implementation of MasterControl’s cGCP software system include:

  • Efficiently managing all the documents, tasks, and processes that must be tracked during a clinical trial for compliance purposes
  • Electronically handling and tracking the overwhelming volume of documents that make up a clinical TMF
  • Importing and exporting high-value batches from a variety of sources (internal, CRO, clinical site, etc.)
  • Tracking site documentation and trial eligibility information from hundreds of sites for various clinical studies
  • Improving the quality and reliability of clinical data
  • Reducing negative findings and open cases from audit findings
  • Maintaining training records for cGCP compliance purposes

Here's how the MasterControl cGCP software system helps solve or simplify clinical headaches:

  • MasterControl's unique Reference Model-TMF JumpStart configuration is based on the DIA Reference Model which increases efficiency and provides a central, standardized repository for all required TMF documentation
  • Provides a variety of methods for batch importing and exporting of content to and from the system
  • The TMF project management capability allows users to plan their TMF documents and tasks as projects with automated task reminders and updates as tasks are executed, escalated, and promoted though various lifecycles
  • Each clinical site's information and documents (including facilities, equipment, past trial participation, and audit history as well as site- and study- specific documents) can be linked, searched, and reported on
  • Integrated processes, audits, and site information allow quality tasks to be executed and closed out effectively and conclusively for enhanced compliance
  • Training can be customized by user role and methods used (i.e., ad hoc, virtual class, etc.) and can take advantage of available proficiency tools such as questionnaires, tests, and quizzes

For More Information on cGCP Software Systems

For more information about MasterControl’s cGCP software systems for ensuring GCP compliance, please feel free to contact a MasterControl representative.