Sponsor SOP Package: For the Management of GCP-Compliant Clinical Trials

In need of regulatory-compliant procedures for the management of clinical trials within your Sponsor organization?

WCG now offers Sponsors a regulatory-compliant and operationally lean suite of Standard Operating Procedures (SOPs) curated to Sponsors utilizing a highly outsourced operational model.

With this suite, Sponsors will receive 26 individual procedural documents, including 2 policy-level documents and 24 SOP-level documents to use as-is, or to customize to meet the organization’s specific needs. These documents have been developed by a multidisciplinary bench of industry experts, while leveraging insights gained through WCG Avoca’s Quality Consortium and consulting expertise. All documents provided comply with applicable federal regulatory and harmonized guidances, including the U.S. Code of Federal Regulation, the EU Regulation and Directives, and ICH Guidelines.

Procedural documents cover content in relation to the following:

• General Policy
  Includes antibribery/anticorruption, privacy and confidentiality

• General Procedures
  Includes procedural development, personnel management, and contractual agreements

• Clinical Development
  Includes trial document development, safety management, and blinding procedures

• Clinical Operations
  Includes site management and monitoring, deviations, and trial supply management

• Quality Assurance
  Includes inspection preparation, audit management, management of issues and misconduct, and qualification of service providers

• Data Management
  Includes data management processes for study start-up, ongoing maintenance, and study close-out activities

• Regulatory Affairs
  Includes regulatory submissions, reporting requirements and registries

• Project Management
  Includes transfer of regulatory obligations, project planning and communication, study oversight, trial master files, and risk management

For additional information on this high-quality suite of foundational procedures for Sponsors, please reach out to James DeFalco at jdefalco@wcgclinical.com.