Pharmacovigilance

Medical Safety Experts
We stay current with industry best practices and mandatory regulatory reporting requirements. Our focus allows us to provide solutions tailored to individual client needs. We deliver flexible, client-driven solutions to mitigate risk and ensure regulatory compliance. Pharm-Olam offers integrated services for multi-national studies to help sponsors develop and implement safety and surveillance programs for products across all therapeutic areas. Our safety data base, developed by ARISg, is a validated 21 CRF Part 11 compliant for all phases of clinical trials and post-marketing pharmacovigilance.

Our pharmacovigilance experts specialize in managing clinical trial AEs and SAEs, including initial receipt, case processing and follow-up, medical review, and closure. Our services include:

AE case processing including SAE management and expedited reporting in the US, EU, and other countries
Responsible Person for EudraVigilance
Generation of MedWatch 3500A/CIOMS I forms
Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction

Electronic Reporting

Pharm-Olam provides event reporting to ensure all regulatory timelines are met in compliance with ICH, FDA and EMEA standards. With our skills in many languages and knowledge of local medical practices we can communicate clearly with reporters to make sure we receive complete information for each safety event. Our system also allows sponsors to monitor safety data early to identify product risks and trends. Pharm-Olam uses a leading web-based management system to collect, assess and report adverse event information to regulatory agencies, including the EMEA and FDA. We can electronically process SAEs, SUSARs, and ADRs for reporting to sponsors, regulatory agencies, sites and ethics committees.