Comprehensive Pharmacovigilance Solutions to Ensure Drug Safety
McHade offers a full range of pharmacovigilance (PV) services to support your drug safety needs, from basic adverse event reporting to full-service PV solutions. Our in-house capabilities and trusted partnerships allow us to provide seamless drug safety monitoring, ensuring compliance with global regulatory standards.
Tailored Pharmacovigilance Services to Meet Your Needs
Our Aim is to Ensure Drug Safety & Regulatory Compliance
McHade’s pharmacovigilance services are designed to safeguard patients by ensuring that drug safety issues are identified, assessed, and addressed promptly. From basic adverse event reporting to comprehensive safety monitoring and reporting services, we provide customized solutions that meet your needs and comply with global regulatory requirements.
Frequently Asked Questions About Pharmacovigilance
What services are included in McHade’s basic adverse event reporting?
We collect drug safety reports, assess their severity, follow up with healthcare providers, and cascade completed reports to sponsors and manufacturers.
What full-service pharmacovigilance capabilities does McHade offer?
Our full-service PV includes ADR case processing, medical review, safety database validation, regulatory reporting, literature reviews, signal detection, benefit-risk evaluation, and more.
How does McHade ensure compliance with global pharmacovigilance regulations?
We provide comprehensive regulatory support, including PBRERs, PADERs, DSURs, REMS, and EU-QPPV services, ensuring compliance with local and international requirements.
How does McHade support drug safety in clinical trials?
We offer safety protocol support for clinical trials, including drug safety monitoring, adverse event reporting, and regulatory submissions for investigational products.
What type of reporting does McHade provide for pharmacovigilance?
We handle the production, generation, and submission of regulatory reports, including PBRERs, PADERs, ASRs, SBRs, and DSURs, ensuring timely and accurate submissions.