Flexible outsourcing solutions of drug safety functions allow you to focus your internal resources on your core mission of discovering new drugs, or supervising the safety profile of your marketed products.

Our hands-on operational support across a range of routine pharmacovigilance activities helps you meet your regulatory obligations or address pressing safety issues. We support internal pharmacovigilance departments by providing drug safety services to assist with special projects, backlog and increased volume challenges. With our experience, we can augment your internal department by working according to your quality practices and workflow to provide the drug safety support you need.

You can rely on our team’s broad pharmacovigilance and medical expertise, which allows us to offer you the following:

Pharmacoviligance team
Case management services
Aggregate reporting services
Literature review services
Medical review & writing services

Pharmacovigilance team

The Medical Safety Analysis team with board certified physicians and scientists provides you with expertise gained in:

• Global pharmaceutical companies and Accovion
• Clinical trials (all phases including first-in-man), mega trials and post marketing surveillance
• A wide range of therapeutic areas, including cardiovascular diseases, metabolism, rheumatology, oncology, anti-infectives, anti-allergics, gastroenterology, endocrinology, vaccines and blood products

The Pharmacovigilance team includes medical documentalists, nurses, scientists and technicians with extensive experience in:

• Clinical trials including mega trials and post marketing surveillance
• Global pharmaceutical companies, other pharmaceutical companies, CROs, and Accovion
• Use of Clintrace™, ARISg™, and Argus Safety™ (including user support, data retrieval, compliance monitoring, etc.)
• MedDRA expertise

Case management services

• Serious adverse event (SAE) management including collection, documentation, case processing, qualified medical evaluation and assessment, active query process and follow-up
• Regulatory reporting of SUSARs and other safety issues from clinical trials to national authorities, European Medicines Agency, concerned ethics committees and investigators
• Management of ADR information from the post marketing area including documentation, case processing, qualified medical evaluation and assessment, active query process and follow-up
• Regulatory reporting of serious ADRs to national authorities and European Medicines Agency
• Electronic individual case safety report (ICSR) reporting according to ICH E2B via EVWEB
• Coding (MedDRA, WHO-DD) including regular coding reviews
• Compliance monitoring

Aggregate reporting services

• Preparation and submission of annual safety reports (ASRs)
• Preparation of periodic safety update reports (PSURs)
• Preparation of other ad hoc safety reports

Literature review services

• Literature reviews on data provided by your company or retrieved in collaboration with an established literature service provider

Medical review and writing services

• Preparation and update of risk management plans (EU-RMP) based on your available data on the clinical and non-clinical aspects, structuring the epidemiological information and evaluation of additional topics (according to EU requirements)
• Document review (clinical study protocol, informed consent form, clinical study report, investigator brochure, etc.)
• Writing of patient safety narratives for study reports