Effective Medical is a full service agency with expertise in all aspects of pharmacovigilance and regulatory writing services. We can assist throughout Phases I-IV of the drug development lifecycle and work both directly with pharmaceutical/biopharmaceutical firms and indirectly partnering alongside major Clinical Research Organisations (CRO’s). We provide a flexible approach and can tailor all services to suit individual needs.
As a privately owned organisation, we are able to modify our operating approach to suit a customer’s specific requirements. With some customer and partner engagements, we are used as an ‘overflow’; making services available at short notice when required to assist in meeting very tight deadlines with complex drug submissions. Other customers and partners prefer to outsource entire programmes or work to us. We will flex to suit your needs.
Effective pharmacovigilance is the cornerstone of any healthcare company, and a failure to have robust and transparent processes in place can result in heavy fines and revocation of license to operate. Pharmacovigilance (or PV) is a continuingly evolving science and requirements have seen notable advancement in recent years, most significantly in the European Union for which developments are ongoing.
Effective Medical provides a comprehensive range of regulatory-compliant PV services delivered by experts with many years of experience within the industry. Our services cover both the pre- and post-marketed stages of drug development and we pride ourselves in our ability to provide tailored and innovative solutions which exceed the requirements of our partners.
PHARMACOVIGILANCE SERVICES WE OFFER INCLUDE
- Signal detection and management activities
- literature services
- safety processes and SOPs
- regulatory communications
- development and implementation of compliant pharmacovigilance, including provision of an EU QPPV
- case processing (data entry,narrative,causality assessment and MedDRA coding)
- Ad-hoc safety communications