Our drug safety team is made up of pharmacists, physicians and scientists with extensive experience in the pharmaceutical industry and in the field of drug safety.
HPM assists companies in setting-up drug safety reporting systems. We provide full safety system setup services including the preparation of all SOPs, access to the validated Drug Safety Database Basecon and reporting to health authorities using the mandatory E2B format.
In clinical trials and post-marketing setups, we perform individual case processing including data entry, narrative writing, causality assessments and timely reporting to health authorities, investigators and ethics committees.
HPM also prepares periodic safety update reports, annual safety reports, risk management plans, responses to regulatory authorities’ queries, issue work-ups and other safety documents.
Our drug safety team is committed to work according to all regulations and international standards and we have been successfully audited several times.
For more information on the validated Drug Safety Database Basecon, please visit:
