PERC’s Project Management Team is committed to quality service. We fully understand how important it is to carry out your trial in the most cost-efficient manner, while addressing regulatory details. All members of our Project Management Team maintain their annual research certification requirements and are dedicated to conducting trials under the applicable regulations and International Conference on Harmonization of GCP Guidelines.
PERC is also prepared to meet your clinical trial monitoring needs. Our skilled Clinical Research Associates (CRA - Monitors) are individually assigned to maintain site continuity, and are well versed in both monitoring and regulatory reporting.
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
- Site Team Training In All Facets of Protocol and Trial Management
- Site 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
- Clinical Trial Monitoring Adherence 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