Standardizing Processes in Pharmacovigilance Information Management with the Release of VigilanceExpertTM 5.0

    Listening to our customers has always played a significant part in AMPLEXOR’s product research and development (R&D). Our account managers are in constant contact with their clients and we also run events such as our annual BE THE EXPERT 2019 Training and Conference, which takes place this year in Provence, France, and provides an opportunity for customers to network, share experiences and best practices and to give feedback to us on what they need from AMPLEXOR solutions and services.

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    We have channeled this feedback into the launch of AMPLEXOR VigilanceExpertTM 5.0, the latest addition to our Life Sciences Suite of solutions. This is a suite that is designed to helps Life Sciences companies overcome the key challenges they face in Regulatory Affairs (RA), Research and Development (R&D), Quality Assurance /Quality Control (QA / QC), and Pharmacovigilance (PV).

    Addressing Pharmacovigilance

    It’s Pharmacovigilance where VigilanceExpertTM 5.0 can really make a difference for Life Sciences firms. Pharmacovigilance involves the collecting, recording, assessment and reporting of the adverse effects of drugs and must be stored in a company’s database and reported to authorities within strictly defined timelines in a compliant electronic format. 

    This is a process that’s fully supported in VigilanceExpertTM 5.0 and is flexible for adaptation to a customer’s specific requirements through simple reconfiguration. It also includes embedded gateway functionality for direct electronic submission of safety cases to EMA, FDA and other health authorities as well as periodical reporting capabilities. 

    With the new ISO ICSR / ICH E2B R(3) electronic reporting format requirements, it felt like the right time to launch a completely redesigned VigilanceExpertTM 5.0, and this new version completely standardizes the processes around pharmacovigilance information management, meaning a much simpler and more efficient experience for any users.

    Data consistency across modules

    VigilanceExpertTM 5.0 can make even more of a difference when deployed in conjunction with other modules within the AMPLEXOR Life Sciences Suite of solutions.

    Given that data plays such an important role in so many elements of modern Life Sciences, data consistency is a major challenge faced by many in the industry. By deploying VigilanceExpertTM 5.0 as part of the broader solution suite, it will significantly increase efficiencies through data consistency across modules.

    There is no one else in the market that can offer such a breadth of solutions with such advanced functionality, either on premise or cloud-based solution according to client preference.

    It’s a highly flexible solution and a drastic move forward for any organization that wants to improve its pharmacovigilance. We are proud of the time, effort and resource that went into making this new solution and can’t wait to see how it improves life for our Life Sciences customers.

    Click here to learn more about VigilanceExpertTM 5.0 and the rest of the AMPLEXOR Life Sciences Suite of solutions.

    Published on 05/04/19    Last updated on 10/04/19

    #Regulatory Information Management (RIM), #Pharmacovigilance, #Safety, #Reporting

    About the author

    Elvis Paćelat is Vice President Compliance Management at AMPLEXOR Life Sciences. Elvis is a business and technology executive with more than two decades of international experience in the Life Sciences market. With detailed technical understanding and expertise in compliance and regulatory content management solutions for Life Sciences, Elvis is a specialist in business impact analysis. As AMPLEXOR’s VP Compliance Management, he is responsible for driving the corporate strategy and market success of the AMPLEXOR Life Sciences’ suite business. Elvis is committed to delivering benefit for clients, partners and shareholders, whilst supporting client-centric strategies and spearheading groundbreaking innovations.

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