Audience
Drug Discovery solution for pharmaceutical organizations
About adWATCH
adWATCH - AE helps pharmaceutical organizations manage and report adverse events that occur during clinical trials. adWATCH - AE gives the reporter at a clinic, hospital, or investigative site a fast and effective means of generating and managing Adverse Event Reports (AERs) and reporting to the regulatory departments and government agencies. An adverse effect is a negative or dangerous effect experienced by a patient and caused by drugs and/or medical devices. Adverse event reporting requires the tracking of all medical complaint case information, resulting in the generation of MedWatch reports, CIOMS reports and additional reports for management. adWATCH - AE allows researchers, physician investigators, Contract Research Organizations (CROs), clinical trial specialists, and other health professionals to produce and file AERs in the FDA mandated MedWatch and/or CIOMS format.2
Other Popular Alternatives & Related Software
Veeva Vault Safety
Veeva Vault Safety is a modern individual case safety report management system that supports the intake, processing, and submission of adverse events for clinical and post-marketed products. Within one system, sponsors and CROs can process global and domestic adverse events for drugs, biologics, vaccines, devices, and combination products. Built-in gateway connections and reporting rules streamline the submission management of cases to health authorities and distribution to partners. Central coding dictionary management automates semi-annual MedDRA, WHODrug, and EDQM updates. Vault Safety unifies pharmacovigilance systems and processes on a single cloud platform to deliver proactive patient safety. It leverages real-time reports and dashboards and seamless collaboration to provide visibility and compliance for adverse events.
Learn more
Evidex
Automated surveillance of any data source, fully integrated with a GVP IX compliant signal management platform. GVP-IX compliant signal management platform integrated within Evidex and ready to use off-the-shelf. Modernize and audit-proof your management processes without having to move back and forth between platforms and services. Unlock the value of your safety data. When you automate signal detection and management, you can focus not just on regulatory requirements, but on driving value for your organization. Identify safety signals from traditional sources like ICSR databases, FDA Adverse Event Reporting System (FAERS), VigiBase and clinical trial data. Include new data sources such as claims, EHR, and other unstructured data. Bring these pools of information together seamlessly to enhance signaling algorithms, make validations and assessment more efficient, and provide faster answers to drug safety questions.
Learn more
PharmaPendium
PharmaPendium is a comprehensive resource that provides access to FDA and EMA drug approval documents, including pharmacokinetic, pharmacodynamic, and safety profiles. It offers detailed information on drug-drug interactions, adverse effects, and clinical study outcomes, facilitating informed decision-making in drug development and regulatory submissions. The platform's extensive data supports researchers and healthcare professionals in evaluating drug efficacy and safety, contributing to the advancement of pharmaceutical research and patient care. Find information about previous regulatory submissions and profit from precedents to predict agencies’ requirements. Seamlessly move from table view to interactive charts, graphs, and visual aids to easily interrogate and interpret data. Find information by adverse events (MedDRA), targets, indications, drug,s and endpoints using normalized data. Result pages bridge the preclinical to clinical divide.
Learn more
Ennov CTMS
Ennov CTMS facilitates the end-to-end management of clinical trials. The software allows sponsors to be more efficient, to make better decisions, to ensure compliance, to select investigators well, to monitor patient recruitment and to manage finances. Ennov CTMS includes comprehensive directories to manage site personnel (investigators, sub-investigators, study coordinators, pharmacists) and organizations (hospitals, competent authorities, CROs, suppliers).
Ennov CTMS provides functions for tracking patients, patient visits, EDC data, activities, queries, deviations, adverse events, drug supply, monitoring visits and finances. A full complement of reports and dashboards provide total visibility into the status of each study, country, site and investigator to provide the information necessary to make the best decisions possible.
- Comprehensive CTMS software
- Integrated with Ennov Clinical Data Management
- Clear visibility into investigational sites
- Integrated workflow
Learn more
Integrations
No integrations listed.
Company Information
Atlant Systems
atlantsystems.com/atlant/solutions/atwatch-ae/
Videos and Screen Captures
Other Useful Business Software
Simplify Purchasing For Your Business
Simplify every aspect of buying for your business in Order.co. From sourcing products to scaling purchasing across locations to automating your AP and approvals workstreams, Order.co is the platform of choice for growing businesses.
Product Details
Platforms Supported
Cloud
Training
Documentation
Live Online
Support
Online
