Adverse Event Reporting

Transcription

1 Adverse Event Reporting AE Case Receipt When we receive a case, we induct it through a well-oiled process that reduces the number of subsequent queries, classifies events appropriately, and increases the speed of processing and regulatory reporting. The cases are received by our global hubs spread across many centers. All serious and non-serious adverse events are recorded from a number of sources such as clinical trial sites, medical literature databases, caregivers, consumers and sales personnel. The reports are documented in a safety database and assessed according to regulatory reporting requirements. We keep track of the cases to make sure they are completed in time and meet the regulatory timelines. Case Processing Our PV experts enter safety data into the database according to data entry conventions and code all events -- primary diagnosis, concomitant medications etc. They continuously and accurately evaluate the cases armed with any new information from individual case safety reports. At Wincere, we continuously keep track of new information to meet all regulatory reporting requirements. Detail case narratives are prepared and adverse events coded in MedDRA and WHO Drug Dictionary. The entire process is quality checked with source documents and rigorously followed-up. Adverse Event Review To make for a foolproof assessment, our medical specialists review the case for medical accuracy, document coded events, describe the narrative comprehensively and assess causality. All clinically significant events are captured. They also screen every ICSR, conduct safety surveillance to detect any safety signal, verify qualifications for regulatory reporting and then forward it to the sponsor for medical review and approval.

2 Adverse Event reconciliation Wincere s safety data managers work in close coordination with other data management activities to ensure this process goes smoothly. The process of reconciling data between the databases continues till reconciliation is complete with no outstanding issues. Wincere attaches special significance to reviewing reconciliation for oncology clinical trials. For example, progression in disease that causes hospitalization but not death may not be reported as serious in oncology clinical trials. This is a protocol specific determination that has to be established prior to beginning reconciliation of a study. The tools we use to manage this process are: * Reconciliation spreadsheet (Excel) * Master spreadsheet: documents all discrepancies, the action required to notify appropriate team * Review by a safety data manager * Partnering with group * Listings from safety database * Calendar of study milestones * Data management activities * Listings from clinical database

3 Drug safety reporting to health authorities and stakeholders Reports with detailed medical and risk assessment plans as well as an executive summary are prepared by our medical writing experts. They guide you through the process to ensure that all reporting forms are medically consistent. The idea is to streamline the periodic report preparation process. This makes for better surveillance and signal detection and ensures greater patient safety. We offer an array of drug safety services, including but not limited to: * Periodic Safety Update Reports (PSURs), Annual Drug Safety Reports. * Periodic Adverse Drug Experience * Developing Safety Update Reports (DSURs) * Expedited reports including MedWatch, Council for International Organizations of Medical Sciences I (CIOMS I) and Vaccine Adverse Event Reporting System (VAERS) Blockbuster drugs are periodically withdrawn from the market following safety issues. International regulatory frameworks are stricter compliance is not an exception anymore, it is the norm. Safety monitoring is more stringent than ever before. The backdrop is perfect for the best life sciences companies to thrive and the not-so-quality conscious to perish. Companies are increasingly sensing the merits of embracing a proactive pharmacovigilance (PV) program, an essential tool that helps them detect and manage emerging safety risks. A strong pharmacovigilance outlook also makes for regulatory compliance and cost reductions.

4 is now a critical phase in the clinical development programs of pharmaceutical companies. As safety regulations get periodically revised, companies have to invest time and again in safety data collection, analysis and regulations. Wincere steps in here to help life sciences and pharmaceutical companies minimize costs despite adhering to a foolproof compliance program. Our (PV) Services work on a partnership model. Companies benefit from our domain knowledge, global reach, quality systems approach and multidisciplinary safety expertise. We also help our partners stick to reporting timelines of FDA, EMEA, MHRA and other regulatory authorities. For us, pharmacovigilance is a continuous process that lasts through the lifecycle of a product. Essentially, it also means we ensure that no drug is withdrawn from the market for want of high quality pharmacovigilance. Our PV Services portfolio Wincere s repertoire includes best in the league pharmacovigilance consultancy, end-to-end management of the project, processing of serious adverse event cases as well as Individual Case Safety Reports (ICSR) at all stages including follow-up, MedDRA and WHODD coding, creating narratives for cases, global case reporting, managing safety data and an international safety database and preparation of safety update reports. What our PV Services offer * Risk management and Risk Evaluation Mitigation Strategies keeping in mind new compliance requirements of FDA and EU regulations * Compliance tracking * Case Processing, tracking and reporting: Serious Adverse Events, Individual Case Report Forms * Surveillance: signal detection and monitoring * PV processes that match global standards * Timely regulatory submissions compliant with global standards * Large volumes of safety data integrated and analyzed * PV metrics that allow immediate action

5 * Resolution of all issues with utmost immediacy * Industry best technologies and tools Our PV experts handle the process of adverse reporting logically, dividing it into actionable steps: case receipt, case processing, medical review and submission.

6 Why us? We take pride in blending next-generation technology with the classical approach of scientific excellence thereby creating a robust and cost-effective clinical trial process. Our resident experts in wide-ranging therapeutic areas identify potential clinical trial challenges and make specific recommendations to suit individual client needs. Wincere provides integrated custom solutions unique for its technology-driven user-friendly interface specializing in efficient delivery. Our use of technology for gamification of the clinical development process, adherence to strict compliance standards and offshore 24x7 support results in reduced costs and timelines with much-needed medical therapies reaching patients faster. The goal at Wincere is simple- to make the data handling process absolutely cost-efficient, crisp, process-driven and thus enjoyable. WINCERE INC Mission College Blvd, Suite 290 Santa Clara, CA UNITED STATES