Clinical Vendor Management


Supplier Management Solutions Critical to Quality Management

In today’s virtual business world, no organization can do it alone, and as the trend toward outsourcing clinical research continues to grow, those charged with vendor qualification, selection, contracting, and ongoing oversight must be ready to meet these expectations. Accountability for compliance cannot be outsourced, so it goes without saying that a quality systems-based approaches to risk mitigation, and risk management, are effective tools for ensuring successful third party vendor partnerships and critical to the success of all parties involved. The management of clinical trials can be the most expensive and time consuming part of developing a new product. In addition to managing documents, sites, protocols and studies, one of the most crucial elements of handling clinical trials is clinical vendor management. These clinical vendors may include technology vendors, contract research organizations (CROs), product distributors, clinical laboratories, and other third party partners.

The processes and protocols involved in managing clinical trials inevitably change over time and new vendors, suppliers, and other third parties are continually added to the mix. But just like a skilled juggler makes difficult skills look easy, you can flawlessly execute your organization’s clinical vendor management by using the right professional tools. An integrated, comprehensive software solution can help ensure that you never drop the ball when it comes to efficient and thorough clinical vendor management.

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White Paper: How to Successfully Manage Your Suppliers and Ensure Product Safety and Compliance
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Product Data Sheet: MasterControl eTMF Manager™
Product Data Sheet: MasterControl Supplier™
Product Data Sheet: MasterControl Clinical Quality Management System (CQMS)™”
Interactive and Live Demonstration: MasterControl Quality Management System (QMS) Overview
Consulting Services: MasterControl Quality and Compliance Consulting™ (QCC) Supply Chain Management Services


Effective Clinical Vendor Management with MasterControl CQMS

The MasterControl Clinical Quality Management System (CQMS) is a holistic solution designed to manage all of the vendors, documents, tasks, processes, relationships, audits, and training that must be administered and controlled throughout the life of a clinical trial. MasterControl CQMS is a complete solution designed to increase efficiency and reuse of information while streamlining the processes and tasks that must be executed during the length of a clinical trial. The solution incorporates partner management tools that expedite the handling of clinical vendor relationships and the qualification component of clinical vendor management.

Supply Chain Management Process

Tools that Facilitate Comprehensive Clinical Vendor Management

MasterControl’s supplier management tool handles all crucial information about the various vendors with which your organization does business. The solution provides a single source for managing information, documents, and interactions with vendors in order to provide an efficient and transparent understanding when selecting a vendor as an extension of the organization. It provides risk-based tools that enable organizations to better select and qualify vendors.

Because transparency into the relationship and capabilities of vendors is essential in clinical trials, the solution gives users a central information repository for essential elements of clinical vendor management such as contact detail, geographic capabilities, study aspect specialization, therapeutic area experience, and many other details.

The system also allows for viewing previously conducted audit reports and findings, in addition to providing the ability to schedule audits of the vendor.

Critical partner-related documents such as correspondence, contracts, agreements, and study documentation are easily accessible as well.

Additional Benefits of the MasterControl CQMS

Aside from offering the most comprehensive clinical vendor management software tools on the market, the MasterControl CQMS also provides a long list of additional features and benefits, including:

  • A Complete, Integrated Clinical Solution: A clinical trial involves the management of countless vendors, documents, tasks, and processes that are most often dependent upon each other and share common information. Integrated MasterControl modules increase reuse and efficiency throughout the clinical trial process.
  • Industry-recognized Best Practice: The DIA TMF Reference Model on which the MasterControl CQMS is based has been adopted as an industry best practice standard for ensuring completeness of documentation for a clinical trial from various resources both internal and external to an organization.
  • Easy Implementation: As many employees are familiar with the DIA TMF Reference Model, using MasterControl’s Reference Model TMF Jumpstart configuration decreases implementation time, ensures that companies get a more standard configuration, and reduces the learning curve.
  • Effective Risk Management: A complete clinical risk management solution designed to enhance transparency and manage risk throughout the life of a clinical trial, thus improving compliance throughout the clinical trial process.
  • Mobile Access: External light users and mobile users can quickly access information critical to their roles (monitor, auditor, investigators) as well as enhance the flow of information and execution of tasks, thereby reducing cycle time (i.e., review, approval, and training). This is an especially beneficial component of streamlined clinical vendor management.

For More Information on Clinical Vendor Management

For additional details about the clinical vendor management system available from MasterControl, please contact a MasterControl representative.