Our strategic relationship with Drug Safety Management partners enables us to provide the highest quality deliverables across a wide array of clinical services.
Through our preferred partners, we offer drug safety services including Serious Adverse Event (SAE) collection and reporting, subject safety narrative preparation, safety database, safety database reconciliation, and safety data review. In addition, we provide Investigator and Ethics Committee safety notifications, as well as annual reporting services such as IND, EU ASR, and DSURs.
KEY ADVANTAGES TO PARTNERING WITH PRC CLINICAL FOR DRUG SAFETY INCLUDE:
- Experienced Drug Safety staff
- Development of Safety Monitoring Plan
- SAE notifications to sites and sponsor within 24 hours
- Development of Safety Narrative Template
- Full SOPs (Standard Operating Procedures)
DRUG SAFETY MANAGEMENT SERVICES FOR YOUR CLINICAL TRIALS INCLUDE:
- Serious Adverse Event (SAE) collection and reporting
- Subject Narratives
- Safety Database
- Database Reconciliation
- Safety Data Review
- Investigator and Ethic Committee safety notifications
- Annual reporting (IND, EU ASR, and DSURs)
Our preferred partners allow us to provide quality assurance and regulatory compliance services for your clinical trials.
Our quality assurance services include clinical report, protocol development, investigator brochure and clinical laboratory audits. Our compliance staff will meet and discuss your needs and scope of the services. Following the meeting a detailed audit plan is prepared which is reviewed and approved by you before the audit occurs. Following the audit and within 10 working days, a draft report which documents all findings, including deficiencies from the audit.
KEY ADVANTAGES TO PARTNERING WITH PRC CLINICAL FOR QUALITY ASSURANCE AND COMPLIANCE INCLUDE:
- Compliance staff is well versed in ICH Guidance for Industry, Good Clinical Practice, and Good Laboratory Practice
- Detailed Audit Plan which is reviewed and approved by you before the audit
- Audit report provided with 10 working days following the audit
- Full SOPs (Standard Operating Procedures).
QUALITY ASSURANCE AND REGULATORY COMPLIANCE SERVICES FOR YOUR CLINICAL TRIALS INCLUDE:
- Investigator Site Audit
- Clinical Report Audit
- Protocol Development Audit
- Investigator Brochure Audit
- Clinical Laboratory Audit
- Vendor Audit