|
Pharmacovigilance.
Pharmacovigilance and drug safety naturally complement the other
services traditionally provided by CROs. Typically, after SAEs/SADRs/SUSARs
are sent to the drug safety monitoring centre from the Investigator
site and reported to the drug safety team, there can be substantial
dialogue among the monitors, investigator site, site coordinators,
and the drug safety medical monitors and data review personnel,
to clarify the data and to understand fully any extenuating circumstances.
This can be a time consuming and inefficient process involving
multiple parties and often threatening delays to defined reporting
requirements. Using ERGOMED’s drug safety monitoring or pharmacovigilance
service, this process can be handled more effectively and quickly.
Safety data, queries and reports coming from the drug safety unit
are handled by local investigators, with the support of their study
site coordinators who will be conversant with the Sponsor, investigator
and ERGOMED processes. Thus, pharmacovigilance and drug safety
services, integrated with trial monitoring and site support services
on a specific project, is a natural fit, optimising data querying
and reporting to the benefit of the sponsor, patient and regulatory
authorities.
This is the principal reason why ERGOMED has integrated a pharmacovigilance
and drug safety unit; far from being an attractive ‘add-on’ service,
it is a part of the core service which ERGOMED provides. A team
of highly trained and experienced staff members performing data
entry, data review and medical review provides this function. The
team is supported and monitored by the best international industry
drug safety and regulatory consultants all of whom have many years
experience of European and FDA interactions.
ERGOMED has selected the ARIS-g safety database as the information
technology platform of the new unit. ARIS-g is a fully validated,
industry-standard database created for SAE management, reporting
and regulatory reporting (including E2B). As the system is web-based
it allows for maximum flexibility, both within ERGOMED as well
as to ERGOMED’s pharmacovigilance clients.
Medical Monitoring and Safety Database Administration
Medical monitoring and safety database administration tasks include:
• data entry (and missing information assessment and follow up),
• data review (QC process),
• medical review/medical monitoring of every SAE by qualified and experienced
MDs,
• MedDRA Coding (indication, adverse event, medical history, laboratory
values)
• SAE narrative production (in accordance with ICH E3 data elements, MedDRA
terminology, and with the approved template)
• Follow up of reported SAEs to resolution or stabilisation
Regulatory Activities
The following reports can be prepared for or managed on behalf of, the Sponsor
in accordance with National regulations:
• Suspected Unexpected Serious Adverse Reaction (SUSAR)
reporting to Regulatory Authorities
• Submission of expedited reports to Investigators
• Ad hoc reports to Regulatory Authorities
• Ad hoc reports to Ethics committees
• Annual Safety Report documents for:
• Line listings
• Summary Tabulations of SUSARs and other reports in accepted terminologies
(MedDRA)
• Risk/Benefit analysis (to be produced with Sponsor) as a requirement
of the EU Clinical Trials Directive
|
