Pharmacovigilance

We provide diligent pre- and post-marketing drug safety services (Pharmacovigilance [PV]). We consider patient safety our #1 priority.

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When it Comes to Compliance, Focusing on Case Processing Alone Isn’t Enough

Pharmacovigilance projects are complex and require solid project management. There are many departments involved that often operate in silos, which results in an inability to communicate effectively and duplicated efforts. Organizations can have multiple locations, each with their own set of processes. All these barriers should be broken to allow for complete harmonization across all departments.

It’s no longer enough being compliant with case processing alone. We encourage strategic thinking about Pharmacovigilance, which considers multiple factors and how they intersect.

We Create Global Pharmacovigilance Organizations

We’ve worked with Pharmacovigilance organizations for a long time, and we have mastered the regulations and understand the process. We recognize the effort it takes to become a forward-thinking organization, and we know how to support your transformation.

We Can Help You Transition From Domestic Operations To A Global Organization By

Facilitating the Implementation of Adverse Event Case Processing and Signal Management Systems

Educating Management on the Implications of PASS and PAES

Performing Current State Assessments and Future State Designs for Case Processing

Standardizing Your Processes and Procedures for Compiling and Maintaining your PSMF

Helping Organizations Outsource their Case Processing Activities, and Developing Training Materials for the end Users who will be Performing those Activities

Developing a Program For Implementation of Benefit/Risk Methodology

Key Offerings Include

Adverse Event Case Processing

Risk Management

Outsourcing Activities

PBRER Listings

Signal Detection and Signal Management

PASS/PAES

DSUR Listings

CIOMS II Line Listings

Signaling and Frequency Reports

Advanced Pharmacovigilance

Benefit/Risk

AER Data Reports

Case Processing Metrics

Regulatory Compliance

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Clinical Individual Case Safety Reports

We create regulatory-friendly reports for clinical and marketed products to ensure compliance. Our team delivers client-approved operation procedures such as submission-prepared paperwork.

Aggregation Of Safety Reporting

Our clients can’t afford to forego vital safety information regarding products. We develop periodic reports for a tactical regulatory response, plus country-specific reports.

Risk Management

Our services to help our clients meet product safety issues in an assured, proactive way. We back clients up daily with the progress of clinical and post-approval tactics. Our consulting and preparation services make up the expansion of essential safety specifications and risk minimization tactics.