Comprehensive Drug Safety & Regulatory Compliance Solutions

With a steadfast commitment to drug safety and regulatory compliance, CRK Clinical Research Key provides tailored solutions to support clients throughout the entire product lifecycle.

Leveraging extensive expertise in pharmacovigilance, risk management, and regulatory affairs, CRK delivers high-quality services powered by advanced technology and innovative methodologies. Our dedication to excellence and continuous improvement helps clients navigate complex regulatory landscapes with confidence, ensuring patient safety and public health.

Our Services Include:

Clinical Trials Safety Management:

• SMA preparation
• Full processing of individual cases
• Preparation of periodic reports (line listings, DSUR)

Post-Marketing Activities:

• SMA preparation
• Literature search and review
• Product complaint management
• PSMF preparation and maintenance
• Risk and crisis management consulting (RMP preparation)
• Qualified Person for Pharmacovigilance (QPPV) in Kenya
• Local Pharmacovigilance (PV) contact person
• Aggregate periodic reporting (PSUR, etc.)
• Safety database hosting & electronic regulatory reporting
• Global coordination & reporting to competent authorities
• Generation of CIOMS reports
• Product reporting within XEVMPD

Trust CRK to ensure the highest standards of safety, compliance, and efficiency in clinical research and post-marketing surveillance.