Pivotal Clinical Trials (conducted under Good Clinical Practices, GCP)

Activities in support of GCP studies include:
• Helping Sponsors design a development plan and negotiate the plan with the CVM
• Developing or assisting with development of protocols and case report forms
• Preparing and producing Investigator manuals, casebooks, owner diaries and supporting materials
• Developing study specific SOPs (Standard Operating Procedures) in consultation with the Sponsor
• Identifying, qualifying, and training investigators
• Monitoring and project-managing the trial
• Managing clinical trial material (test article)
• Optimizing patient recruitment
• Reporting and managing adverse events
• Data management
• Statistical services
• Quality Control and Quality Assurance services
• Writing Final Reports
• Coordinating the regulatory submission process, including pagination, copying, assembling and shipping
• Writing and editing the FOI summary and proposed label language
• Communicating and negotiating with the FDA Center for Veterinary Medicine

To request more information on AlcheraBio’s Contract Research services in the area of GCP trials, please click here.