Pharmacovigilance

• Who we are
• What we do
• What you get

Who we are

The Pharmacovigilance group currently comprises 25 members, including 6 MDs.

Expertise and Experience

You can benefit from our many years of experience, knowledge and cross-functional work in over 20 successful submissions to the FDA and EU authorities in key therapeutic areas.

Highly skilled pharmacovigilance specialists ensure continuous SAE processing, MedDRA coding and timely distribution of regulatory reports.

Board-certified physicians with special knowledge in key therapeutic areas ensure ongoing data analysis and safety evaluation throughout your studies and your product lifecycle.

Profit by our industry-wide safety experience with investigational new drugs in over numerous studies ranging from first-in-man studies and phase III megatrials to phase IV studies in clinical development, including the pharmacovigilance of marketed products.

Our clients rank among the "Top 20" pharmaceutical companies as well as mid-size and small companies.

ACCOVION, especially the pharmacovigilance department, underwent numerous audits by clients and other organisations and has successfully passed regulatory inspections without any findings by several national authorities.

What we do

ACCOVION offers you full service pharmacovigilance solutions that smoothly integrate with your teams, and expert consultancy you can count on:

• Serious adverse event (SAE) management incl. collection, documentation, qualified medical evaluation and assessment, active query process and follow-up
• SAE processing within required timeframes in either the client's (e.g. ClinTrace™ and ARISg™) and other non-commercial systems or in ACCOVION's database ARGUS Safety™
• Qualified medical review of all SAEs for data completeness and medical sense and safety monitoring
• Appropriate MedDRA-Coding
• Writing of safety narratives for study reports
• Regulatory reporting to authorities, investigators, and ethics committees
• Electronic Safety Reporting according to ICH E2B
• Preparation and submission of Annual Safety Reports (ASRs) and Periodic Safety Update Reports (PSURs)
• Data reconciliation of pharmacovigilance and clinical trials databases
• Regulatory safety support including ad hoc responses to regulatory authorities
• Project-specific standard operation procedures
• Risk assessment and risk management

And, last, but no least,

• Pharmacovigilance consultancy, particularly in the ever growing area of European pharmacovigilance requirements

What you get

ACCOVION offers you full-service pharmacovigilance solutions, including support for the regulatory transition of your product from submission to registration. Just as important: we ensure that you are well prepared for the first two years on the market, the most critical years from both a patient safety and a product market perspective.

Let ACCOVION be your strategic pharmacovigilance partner:

• Acting as your drug safety department
• Augmenting your safety resources
• Supporting your clinical trials and submissions
• Providing consultancy

Contact us and find out how we can support you with clinical safety and pharmacovigilance services.

ACCOVIONs client-specific processes ensure cost-effectiveness, high quality, regulatory compliance and reliability

Our processes are the result of more than 16 years of experience in pharmacovigilance standards and training. We follow good pharmacovigilance practices, giving expert attention to risk detection and medical assessment of safety signals. Compliance with regulatory requirements - such as expedited reporting to EMEA, national agencies, concerned ethics committees, and investigators in a timely manner - is the natural result.

Full pharmacovigilance system audits and project specific pharmacovigilance audits were successfully passed. Processes and systems used in the pharmacovigilance department were subject of these reviews including our comprehensive state-of-the-art set of pharmacovigilance SOPs and Working Procedures. Affirmative feedback by our clients and the auditors was also received on qualification, extensive experience and regulatory knowledge of our pharmacovigilance staff, our ability to transfer applicable requirements into project specific processes and on ACCOVION's safety-database. This was also confirmed during a regulatory inspection, conducted by the German local competent authority in May 2006 and after our Pharmacovigilance department was involved in an MHRA Inspection of a client in October 2006.