Clinical Trial Management

Accurate, clean, and supportable protocol-acquired data are the manifestations of PERC’s services. Quality pervades all activities. We understand your time constraints and have the ability to implement your project quickly and within budget.

Site Management

PERC’s clinical operation team is committed to quality service.

The Team

Facilitates and assures that trials are conducted under the applicable regulations and International Conference on Harmonization GCP Guidelines

• Combines speed, accuracy, efficiency, and accountability
• Provides CRAs skilled in monitoring and regulatory compliance issues
• Assigns an experienced clinical trial manager to act as liaison to all parties
• Adheres to the appropriate internal standard operating procedures (SOPs), adapts to the client’s or PERC’s, or creates customized SOPs specific to the project’s needs
• Acts as liaison for participating Site IRB affairs and approvals
• Implements and/or facilitates U.S. and governmental submissions and correspondence based on the client’s needs

PERC tailors services to project-specific needs:

• Trial Set-up: Investigator recruitment, pre-trial site qualification visits, and management of site/third-party vendor contract/budget negotiations
• CRF development or review
• Subject safety and regulatory compliance
• Site team training in all facets of protocol and trial management
• Initiation, interim monitoring, and close-out visits
• Subject safety and regulatory compliance
• Acquisition and delivery of trial supplies
• Clinical site/third-party vendor payments
• Expediting accurate, clean and supportable protocol acquired data
• Collection and archiving regulatory documentation
• Quality assurance reviews/FDA audit prep

Independent Auditing

PERC provides third-party auditing or services customized to meet project-specific needs. Whether establishing a Data Safety Monitoring Board or responding to an FDA data audit request, PERC delivers specialized assistance. PERC understands time constraints and has the know-how to get your project up and running quickly, as well as the resources to complete any task within tight deadlines.

• Experienced auditors/reviewers and auditing/reviewing teams
• Customized SOPs
• Auditors skilled in monitoring and regulatory compliance issues
• Auditors and data reviewers trained to protocol-specific and disease-specific indications
• A clinical trial/project manager to act as the liaison between all parties, including regulatory agencies
  

PERC customizes services for auditing/review needs:

• Arrange DSMB/CEC and conduct meetings specific to the project’s therapeutic requirements
• Produce and implement SOPs or DSMB/CEC rules of engagement meeting FDA requirements
• Develop auditing plans meeting FDA concurrence
• Deliver project reports
• Manage DSMB/CEC third-party contracts and payments
• Provide accurate, documented tracking of the project’s materials, e.g., auditing worksheets or data measurements