There are no trade-offs when it comes to drug safety. Excellence in technology, process efficiency, regulatory compliance and product quality are all required for a successful launch.
HighPoint has been there, for pharmaceutical companies around the globe, to see our clients through every stage of the software implementation life cycle. Our consultants stay ahead of international regulations and industry-standard technologies to keep projects moving — and moving fast. We know our clients face increasingly daunting compliance guidelines and timeframes. Our job is to get them there. Our experience makes it possible.
It Takes Practice
HighPoint’s work in pharmacovigilance starts with best practices we’ve refined over thousands of projects for life sciences clients.
At the top level, this means assessing existing systems and operations, then planning and implementing technology and processes that increase quality, efficiency, communication standards and compliance throughout an organization. Our pharmacovigilance experts enact best practices for the data collection and entry necessary for filing safety reports. And they work to define, implement or update workflows, processes, SOPs and user manuals to usher safety output forward, on time.
HighPoint works with project managers, sponsors and other stakeholders over the course of your entire project to ensure it remains relevant within the business and regulatory framework of your company. We will also assess your PM processes to show you where clear improvements can be made.
Is every aspect of your organization compliant with 21 CFR Part 11, EMA and ICH guidelines? HighPoint can give you the answer with full system and process audits. From there, we’ll develop SOPs for data management, reporting and other processes that will address compliance issues wherever they arise.
Software Evaluation & Selection
Streamlining pharmacovigilance software is easier when you’ve seen it all. We have. HighPoint consultants can define clear software evaluation criteria unique to your company’s needs, issuing RFPs and evaluating responses to guide your decisions.
Our support continues into deployment. We can help you understand and weigh options such as software purchasing, outside hosting, CRO services, etc., by developing a total cost of ownership (TCO) model that clearly outlines which deployment method best suits your financial, technical and safety needs.
Custom Pharmacovigilance Software
No single system can do it all, especially not for one company. In our experience, custom-developed software is often the answer.
With a HighPoint pharmacovigilance software veteran at your side, you can outline criteria for a custom solution. From there, we work closely with your entire business group to develop, validate and implement software that closes the gap for your safety processes.
Oracle Argus Safety Implementation
As an Oracle Argus Specialized Implementation Partner, HighPoint has the hands-on experience to take you through the full life cycle of system execution.
We’ve developed a structured approach both to version upgrades and fresh implementations that includes process redesign, configuration, data migration, validation, integration, report development and go-live, as well as training and post-implementation support.
Systems Validation Services
Proving that your pharmacovigilance system is functioning is second only to keeping it going. HighPoint has extensive experience employing up-to-date validation kits for Oracle Argus, Oracle AERS, and solution-agnostic accelerators. We work closely with your quality organization to properly document pharmacovigilance evidence — without encumbering the pace or cost of a project.
Data Migration Services
Leave legacy systems — and the anxiety associated with migrating away from them — behind. Our consultants have a deep understanding of pharmacovigilance data, including their sourcing and application, to successfully move your organization to modern, compliant solutions.
HighPoint will work with your team to plan and map out a migration strategy, then move data in discrete phases that allow for strict testing, validation and oversight.
Pharmacovigilance requires understanding at an organizational level. HighPoint can get your team up-to-speed on a variety of topics via either on-site training or remote web conference.
Train end users in the basics of reporting, or review a history of pharmacovigilance with newcomers. Give administrators an overview of Oracle AERS or Argus, or delve into advanced configuration processes based on your organization’s systems. HighPoint training courses can be customized and/or combined to suit the educational needs of your entire team.
Seth WarhaftigVice President, Pharmacovigilance
Seth Warhaftig brings to HighPoint more than 12 years of experience providing software solutions and services in the life science industry. He possesses a thorough knowledge of the drug development process, specifically in the areas of safety and pharmacovigilance, and clinical development and data management. His experience includes strategic planning, business process optimization, global regulatory compliance, custom system design and development, and system implementation and integration.
Prior to joining HighPoint, Seth was the President and CEO of November Research Group, employed as a Safety and Clinical Solution Specialist for Oracle Corporation, the Executive Director of Worldwide Business Development for NetForce, Inc., and a Senior Consultant for Ernst & Young, LLP. Seth also held the positions of Director of Pharmaceutical and Biotechnology Consulting Services for NetForce, leading a 20 person services group, and Oracle Clinical Development Manager for Oracle Corporation.Close
Raul InchaustiSenior Director
BS, Management Information Systems — Pace UniversityClose
20+ years of software solution and service experience in life sciences, including strategic planning, business process optimization, global regulatory compliance, custom system design and development and system implementation and integration. Raul holds particularly deep knowledge in safety and pharmacovigilance.
Alan SummerSenior Director
BS, Electrical Engineering with Computer specialization – Rutgers University BS, Computer Science – Rutgers UniversityClose
20+ years of full-life-cycle development experience in the design and development of internet and client-server software applications in a business environment. Experience in all phases of the system development life cycle performing both project and software development leadership. Expertise in strategic planning, business process optimization and global regulatory compliance.
BE with honors, Mechanical EngineeringClose
10+ years of experience implementing safety solutions — including planning and delivery — for global pharmaceutical companies. As Services Director and Leader of Noida (India) Operations, Anjani possesses expertise in setting up and managing offshore delivery centers. Before HighPoint, Anjani held positions at November Research Group, Argus Safety and Trackwise Service.
BS, Natural Sciences – Xavier UniversityClose
18+ years of experience working in life sciences, with 10+ years in drug safety consulting focusing on project management and business analysis. As Services Director, Lindsay is responsible for the day-to-day management of the U.S. consulting team, and manages client engagements and projects. Before HighPoint, Lindsay held positions at November Research Group, Baxter Healthcare, and Kendle.