Post-marketing and Clinical Trials Patient Support Programmes
Almond Operations – Post marketing and Clinical Trials
Many companies outsource their Pharmacovigilance services as they feel it allows them to focus on other areas of the business. It also reduces their overheads and takes a lot of stress from them. Did you know that EU Pharmacovigilance laws mean that all Fatal or Life-Threatening Unexpected ADRs must be reported as soon as possible but no later than 7 calendar days after first knowledge by the sponsor that a case qualifies, followed by as complete a report as possible within 8 additional calendar days.
Serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be filed as soon as possible but no later than 15 calendar days.