spmd is a service provider founded in 2016 in the USA, offering state of the art (pharmaco-) vigilance services for the pharmaceutical industry.
The founders of spmd have a long standing international experience in clinical development, clinical pharmaceutical research and (pharmaco-) vigilance particularly in Europe and the USA.
Our professional experience includes:
- managing global development projects resulting in successful marketing authorization
- implementation of SOP and Quality Management Systems
- implementation and validation of E2B-compliant (pharmaco-) vigilance databases
- data management including migration of safety data
- generation of Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs) and Risk Management Plans (RMPs)
- provision of drug information services
- managing global drug safety departments
- acting as QP Pharmacovigilance (EU-QPPV)
- conduct of risk management procedures
We strongly believe that (pharmaco-) vigilance management not only is essential for patient’s safety but also is value adding to the company’s pharmaceutical product portfolio.
We offer tailor-made safety solutions either as your full service external (pharmaco-) vigilance department or modular project specific services.
It is worthwhile to compare our services with in-house solutions, especially as a mid size company with limited case volume.
++ Through our exclusive cooperation with spm², a specialized European safety service provider, spmd can offer a E2B compliant safety database and additional professional expertise in the complex regulatory environment of Europe please visit spm² ++