Pharm-Olam International Ltd. Expands Pharmacovigilance Services
“Pharm-Olam provides sponsors timely evaluation and reporting for adverse events to ensure all regulatory timelines are met in compliance with ICH, FDA and EMEA standards”, said Iain Gordon Global Vice President of Business Development, “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.”
POI uses a web-based management system to collect, assess and report adverse event information to regulatory agencies, including the EMEA and FDA. POI can electronically process SAEs, SUSARs, and ADRs for reporting to sponsors, regulatory agencies, sites and ethics committees.
About POI’s Pharmacovigilance Group
Pharm-Olam offers integrated services for global 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. Our safety services include:
• Quality safety and medical coverage with 24/7 call centers • Expedited report generation/submission to regulatory authorities • AE data entry and logging, tracking, coding, and case processing • Data coding for any version of MedDRA and WHO Drug • Narrative writing and causality assessments • Safety assessment for individual case reports • Comprehensive risk management plans • Local language AE translations • Notifications to investigators • DSMB management • Spontaneous reporting activities • Stand alone pharmacovigilance services • Pharmacovigilance consulting
About Pharm-Olam International Pharm-Olam International is a multi-national contract research organization offering a wide range of comprehensive, clinical research services to the pharmaceutical, biotechnology and medical device industries. From Phase I to Phase IV, POI focuses on delivering the highest quality data, achieving targeted enrollment and meeting projected timelines.