Helping you meet the highest safety and regulatory standards
About Pharmacovigilance service
AstaLynx provides pharmacovigilance services that meet the highest regulatory standards. Our dedication to meeting business drivers such as compliance, quality, and customer service enables us to process and analyze cases in a timely and efficient manner. Our in-house team of PV experts work extensively to cover our clients portfolio of products in a highly integrated and global environment, while keeping up to date with current industry trends.
Helping you meet the highest pharmacovigilance standards
We deliver pharmacovigilance services that meet the highest regulatory standards. Our expert team works extensively to cover your firms portfolio of products in a highly integrated global pharmacovigilance department and are set to meet all industry wide requirements. The business drivers that we focus on at all times are compliance, customer service, and proactivity.
Our pharmacovigilance services portfolio
AstaLynx currently collects cases from a variety of sources from both clinical and post-marketing stages. Our case intake activities have been digitalized; cases from different sources are compiled into our intake platform, ADRium-Intake. Cases are then seamlessly transferred to our safety database, ADRium-Safety. Drug safety professionals complete critical steps such as triage, data entry, medical review, quality check, and submission using ADRium-Safety.
AstaLynx’s medical review team performs overall ICSR assessment of properties such as case seriousness, causality, company clinical evaluation, listed/unlisted, signal identification, and MedDRA coding accuracy.
AstaLynx’s medical experts design and implement complete Risk Management Plans (RMP)and Risk Evaluation and Mitigation Strategies (REMS) for our clients products and ensure effectiveness of the risk mitigation measures.
Astalynx’s case intake module, ADRium Intake, works dynamically and recognizes the basic criteria from the source data for ICSR validity, identifies report type (solicited and unsolicited), performs duplicate checks, identifies initial and follow-up case information, and confirms proper case registration. The case intake module allows us to populate the data elements from source data into the data entry page of ADRium safety database.
Our case processing team efficiently works with all the stakeholders including safety partners for ICSR reconciliation, including for regulatory submissions purposes.
AstaLynx provides medical information management services to our clients for managing their medical information queries through our call centers and mailbox management team. Our team of experts can process adverse events and product quality defects received from the medical information queries for integrated ICSR case processing.
Our pharmacovigilance experts perform case triage activities as per criteria such as ICSR validity, product identification, seriousness, causality assessments, and prioritization of cases for regulatory reporting purposes.
Our team of reporting professionals prepare and submit line listings to authorities as required for aggregate ICSR submissions.
AstaLynx’s medical writing experts have decades of experience in writing aggregate reports such as Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Adverse Drug Experience Reports (PADER), Clinical Study Reports (CSR), and ad-hoc reports in response to health authority queries. Our team prepares submission ready aggregate reports including planning and kick-off of the aggregate report schedules, collection of data from different internal stakeholders, and finalization of the reports.
About our Regulatory Affairs service.
Our PV experts will perform end to end data entry activities and enter all the details from the source documents into the database, which include reporter information, patient information, patient medical history, laboratory details, family and surgical history, clinical course, and treatment details of the patient. Our ADRium safety modules maps the unstructured data into E2B format and auto-populates the source data into different fields.
Signal Detection and Management
Here at AsatLynx we provide end to end, tech enabled Signal Detection and Management services. ADRium Signals is our signal detection module which provides a complete solution for all in one signal identification and management. The module allows the users to review drug-event combinations that meet statistical thresholds for quantitative signal detection purposes and to review individual cases for qualitative analysis of signals identification and management .
Learn more about our Pharmacovigilance services
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