November Research Group: “We help you help your patients!”

Carrying a firm mission to deliver products and services that enable the global Health Science industry to improve public and patient safety, November Research Group is a professional services company that specializes in pharmacovigilance training courses and software. Consultants at November Research Group carry deep expertise in all aspects of pharmacovigilance: from the selection of software solutions, through its successful implementation in redesigned business processes. The company also offers suite software solutions that extend the functionality of the global pharmacovigilance system.

Comprised of seasoned drug safety and pharmacovigilance experts, the group have made its presence felt in the US and Europe, and offers an average of 15 years industry expertise with the principle team. Today, the group is commonly recognized for its deep drug safety and pharmacovigilance subject matter expertise. With a successful team that includes pharmacovigilance operational experts who have managed adverse event cases and safety/regulatory departments, information technology experts, software validation professionals, and project managers, the company is ideally suited to supporting entire pharmacovigilance operations, with its broad spectrum of expertise.

Brief insight on products offered by November Research Group
November Research Group has a growing suite of commercially available software solutions that complement and extend the capabilities of off-the-shelf pharmacovigilance systems.

PRIMO- A web-based streamlined data capture system to support the intake on potential adverse event reports.

PRIMO Regulatory- An adverse event management system dedicated to the regulatory authority market. Designed with regulators, for regulators.

Eureka™- A true ad hoc report environment deployed from a web portal.

WebTools™- A suite of web-based utilities to augment Oracle AERS, including a Case Unlock utility and MedDRA Impact Reports.

E2B Viewer- web browser based utility to view E2B files.

Automated Follow-up
Request Form- A web browser based utility that generates and sends a cover letter and case report form with missing data highlighted.

Valuable Clients
Over the last decade, the November Research Group team has been involved in over 75 pharmacovigilance systems implementation projects to help pharmaceutical and medical device companies, CROs, and other life science organizations to deploy a single harmonized database with a truly global workflow. their clients come to them from every sector of the life sciences industry, from the world’s largest pharmaceutical companies to the most innovative biotech startups. To mention a few: Fda, Santen, PPD, CTI, Mylan, Shire, Covidien and biogen idec.

Knowing the Thought Leaders
Seth Warhaftig, President and CEO
Seth brings to November Research Group 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 pharmaco- vigilance, 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 founding November Research Group, Seth was 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.

Alan Summer,Vice President
Carrying an experience of more than 20 years in the IT industry, Alan’s strong management and technical background provide him with the knowledge and skills required to consistently deliver successful solutions on many platforms. For the past twelve years, his focus has been on delivering solutions for the Pharmaceutical and Biotech industries. His expertise includes project management, user requirement gathering, business process re-engineering, application configuration, training, and legacy data conversion. Alan has managed multiple AERS and Argus global implementations.

Prior to joining November Research Group, Alan co-founded LSWorks, which assisted companies with Pharma covigilance needs. Before LSWorks, he was employed by Oracle Corporation as a Senior Principal Consultant where he managed and implemented numerous AERS projects. He also managed several ARISg implementations as a Senior Technical Consultant at First Consulting Group (FCG) and was employed by AT&T as a Senior Developer for a Global Call Center system

Brad Gallien, Vice President
Brad brings to November Research Group more than 20 years of experience in clinical research and development, both within industry and as a software and services provider. He has an overall view of the entire product lifecycle, with specific expertise in clinical data management and pharmacovigilance. His experience includes strategic planning, business process optimization, global regulatory compliance, custom system design and development, and system implementation and integration. Prior to joining November Research Group in October 2005, Brad was employed as the Director of Life Sciences Industry Strategy at Oracle Corporation, the Vice President at NetForce, Inc., and a Manager of Software Systems Support at Syntex. Mr. Gallien also held the positions of Director of Product Management for Oracle AERS for Oracle and various positions in clinical data management and biostatistics at Syntex.

November Research Group’s core values

• Honesty and transparency in everything they do
• Collaboration and teamwork to establish long-term customer relationships
• Leverage accelerators and tools to reduce project risk and cost
• Absolute commitment to make each project successful through an exemplary customer experience

“We have provided services for all sectors of the life sciences industry: from the largest global pharmaceutical companies to emerging biotech and contract research organizations.”