by Anna Kamocsai | Jul 10, 2020
Clinical Safety Experienced safety experts, embedded in your trial from set-up to close-out. From early phase studies to large Phase III programmes, our clinical safety team works as an extension of yours, keeping your study compliant and your patients protected. Our...
by Anna Kamocsai | Jun 10, 2020
Benefit-Risk Management Every product’s benefit-risk balance is under continuous review. Regulators expect you to show that you understand it, manage it and act on new evidence quickly. Our pharmacovigilance team works as an extension of yours, using structured...
by Anna Kamocsai | May 10, 2020
Global and Local Literature Monitoring Global and local literature monitoring plays a critical role in identifying reportable Individual Case Safety Reports (ICSRs) and detecting emerging safety signals. Biomapas provides comprehensive post-authorisation...
by Anna Kamocsai | Apr 10, 2020
Signal Management A safety signal can emerge at any point in a product’s life, from a single case report, a pattern in your data or a paper in a local journal. Finding it early is what protects patients and keeps you ahead of regulators rather than reacting to...
by Anna Kamocsai | Feb 10, 2020
National QPPV / LPPV Network With its wide Local Safety Officers (LSOs) network, Biomapas can fulfill all and any local Marketing Authorisation Holder’s obligations in EU and non-EU countries and perform all local pharmacovigilance representation activities,...
