Pharmacovigilance

Pharmacovigilance is vital to ensure patient safety, data integrity and regulatory compliance. Regulatory guidelines around the world require a high standard safety management system team.

Medical Monitoring

The GreenLight Clinical medical monitoring team provides timely evaluation of SAEs to safeguard patient safety and provide feedback on any potential safety signals that may arise during the trial’s progress. The Medical Monitor can also provide their input regarding subject eligibility and may form part of the Safety Review Committee or Data safety Monitoring Board, as appropriate.

Pharmacovigilance Services

At GreenLight Clinical, we provide end-to-end pharmacovigilance services. We work closely with you to optimise your products’ benefit-risk profile in order to maximise its potential while ensuring patient safety.

We have highly skilled, experienced individuals who are experienced in projects with approved or unapproved medicinal products and devices across multi-disciplinary regulatory authorities. To ensure the provision of exceptional safety management services, our team works closely with:

Medical Monitors

To ensure monitoring of the study drug safety profile to identify, evaluate, and minimise safety-related risks.

Our Regulatory Affairs Team

To ensure regulatory compliance and to stay updated on ever changing regulatory requirements.

Our Quality and Assurance Department

Which is recognised and certified per industry’s best practices.

Technology

GLC has made uncompromised investments in technology and partnered with best-in-class safety databasing system – ArisGlobal – Multivigilance LifeSphere Safety (ArisG), which is customisable per your needs (clinical and post-market drugs, devices, vaccines, etc.), allows high volume safety processing in-house, and is 100% web-based.

Services

Our pharmacovigilance team can provide a wide range of services, which are not limited to:

Sponsor representation as QPPV – (Qualified Person for Pharmacovigilance – Australia, NZ), who can support and provide guidance on safety surveillance for clinical and post-marketing projects.
Complete ICSR management, including tracking, case processing, medical review, regulatory submissions.
Services for periodic reporting, including review and submissions.
Drafting a safety management plan.
Assisting sponsors with Pharmacovigilance Inspections and audits.

Post Marketing Support

At Greenlight Clinical, we understand the importance of meeting TGA marketing authorisation requirements after study completion. That is why we offer the support of our Pharmacovigilance and Device Vigilance experts to help your company stay compliant. We also offer advertising and promotion reviews for TGA compliance and can assist in preparation and submission of post-marketing variations.

We strive to provide seamless support throughout the entire product lifecycle, from development to post-marketing. Trust Greenlight Clinical for all medical monitoring needs and let us help bring your product to market successfully.

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Medical Monitoring & Safety Reporting Pharmacovigilance