HPM provides a customized safety system to help our clients better meet their needs in today’s increasingly complex regulatory environment. Our integrated pharmcovigilance services include the following:

• Whole system setup: supporting your company’s safety projects and representing your company in dealings with health authorities

• Standard Operating Procedures (SOPs): preparing all safety relevant SOPs specifically designed to for your company and to comply with all regulations and quality standards
• Validated database: providing you with our validated database Basecon which is E2B compliant and offers you a flexible, efficient, cost-effective way to have all your safety data in one place. www.basecon.com
• Electronic (E2B) reporting via Eudravigilance Web (EVWEB): reporting any appropriate safety cases to the health authorities via EVWEB. Electronic reporting has been mandatory since November 2005 and we are certified EVWEB users.
• Reporting compliance tracking: monitoring and documenting the compliance of case reporting according to international quality standards.
• EU Qualified Person for Pharmcovigilance (QPPV): our experts in drug safety provide services as EU qualified persons, which is a mandatory key role as presented in volume 9A
• Training: training your staff and investigators on the latest safety standards and regulations.
• Licensing agreements: preparing licensing agreements for the exchange of safety data between you and your licensing partners