Pharmacovigilance

Services

 

Our consultants combine their Pharmacovigilance expertise with information technology to continually stay on top of current global regulations, business issues and trends in the industry to, in turn, help companies meet their best practices for drug safety. We offer support for all stages of the software implementation lifecycle.

Compliance • Development and implementation of systems and business processes to ensure compliance with worldwide government regulations.

Project Oversight • Assistance with medium and long-term project design and implementation to ensure clear and valid objectives and requirements and effective planning and management.

Software Evaluation & Selection • Direction of the software evaluation process from proposal writing through selection to ensure that candidate systems meet financial, technical and safety requirements.

Custom Reporting • Design and development of custom and company-specific reports to augment the out-of-the-box reports available in your commercial system.

Implementation & Upgrade • Comprehensive support for initial implementation or upgrade of your Pharmacovigilance to meet business goals and to comply with worldwide regulatory guidelines.

Data Migration • Planning, executing and testing the migration of legacy data and data from other commercial safety systems into your internal system(s).

 

Best Practices

 

Pharmacovigilance is becoming increasingly critical as public and changing global regulatory pressures require assurances from pharmaceutical companies that the drugs they produce are safe. Pharmacovigilance best practices are the standards for implementation of the various components to ensure that the goal of drug safety is achieved.

HighPoint’s Pharmacovigilance Practice helps companies meet their best practices by combining Pharmacovigilance expertise and information technology to support drug safety units in optimizing quality, compliance, communication and efficiency within their day-to-day processes. Strategically, we look at ways to streamline case management and reporting methods to efficiently meet global regulatory timeframes. We also assist in integrating tools to effectively detect, analyze, and alert Pharmacovigilance staff to new and potentially important information on drug, biologic, vaccine and device-associated adverse reactions within their chosen safety system.

We will work with your team to design and implement optimal processes for individual and aggregate global Pharmacovigilance adverse event reporting. Additionally, we will provide business process expertise in the collection and data entry of safety information and provisions needed for the required regulatory reports. We will provide Pharmacovigilance and data management support to define, implement and/or update requirements for data entry and reporting, workflow processing, the development and harmonization of global processes, SOPs, and User Manuals, and to utilize methods to effectively retrieve and manage the safety output that is generated in a timely manner.

Our consultants combine their Pharmacovigilance expertise with information technology to continually stay on top of current global regulations, business issues and trends in the industry to, in turn, help companies meet their best practices for drug safety.

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