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What is adWATCH?

adWATCH - AE serves as a comprehensive solution for pharmaceutical companies to effectively manage and document adverse events that may occur throughout clinical trials. It offers a rapid and streamlined method for individuals at clinics, hospitals, or research sites to generate and monitor Adverse Event Reports (AERs), ensuring that all necessary information is accurately relayed to regulatory authorities and governmental entities. An adverse event is defined as any harmful or negative reaction a patient experiences as a result of medications or medical devices. The meticulous documentation of these adverse events requires detailed tracking of all medical case specifics, which leads to the production of essential reports such as MedWatch and CIOMS. With the implementation of adWATCH - AE, researchers, physician investigators, Contract Research Organizations (CROs), and various healthcare professionals can efficiently create and submit AERs that comply with FDA standards, following the formats established by both MedWatch and CIOMS. This organized approach not only bolsters adherence to regulatory guidelines but also significantly enhances the oversight of patient safety during the course of clinical trials. Furthermore, the tool's user-friendly interface facilitates collaboration among multiple stakeholders, contributing to a more transparent and accountable research environment.

What is Citeline?

Citeline acts as a comprehensive platform for intelligence and analytics in clinical development, providing life sciences companies with essential real-time data, insights, and tools necessary for making well-informed strategic decisions throughout the drug and device development journey. By gathering and refining an extensive array of datasets concerning global clinical trials, investigators, trial sites, drug development pipelines, and regulatory requirements, it supports multiple functions, including protocol design, feasibility studies, site and investigator selection, enrollment forecasting, competitive analysis, and adherence to disclosure regulations across various regions. The platform features a variety of products, such as Pharmaprojects for tracking drug pipelines, Trialtrove for benchmarking clinical trials, Sitetrove for acquiring site and investigator information, Global Patient Insights to ensure feasibility matches actual patient access, and TrialScope Intelligence/Disclose to navigate the intricacies of regulatory disclosure mandates. Citeline’s diverse functionalities make it an indispensable asset for organizations seeking to optimize their clinical development workflows and improve their strategic decision-making processes. Furthermore, the seamless integration of these tools not only enhances efficiency but also equips organizations to adeptly handle the challenges associated with clinical trials and regulatory compliance in a constantly changing environment. This adaptability is crucial for maintaining competitiveness and ensuring successful outcomes in the fast-paced life sciences sector.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Atlant Systems

Company Website

atlantsystems.com/atlant/solutions/atwatch-ae/

Company Facts

Organization Name

Citeline

Company Location

United States

Company Website

www.citeline.com

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Categories and Features

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