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Description
Citeline serves as a robust platform for clinical development intelligence and analytics, offering life sciences organizations access to real-time research and development data, insights, and tools essential for making informed strategic choices throughout the drug and device development process. By compiling and refining the most comprehensive datasets related to global clinical trials, investigators, trial sites, drug development pipelines, and regulatory stipulations, it aids various functions including protocol design, feasibility assessments, selection of sites and investigators, enrollment predictions, competitive analysis, and tracking compliance with disclosure regulations in different jurisdictions. The platform encompasses several products, such as Pharmaprojects for monitoring drug pipelines, Trialtrove for benchmarking clinical trials, Sitetrove for gathering site and investigator intelligence, Global Patient Insights for ensuring feasibility aligns with actual patient access, and TrialScope Intelligence/Disclose for navigating regulatory disclosure requirements. With its wide range of functionalities, Citeline stands out as a vital resource for organizations aiming to streamline their clinical development processes and enhance their strategic decision-making capabilities. Moreover, the integration of these tools facilitates a more efficient approach to managing the complexities of clinical trials and regulatory compliance in an ever-evolving landscape.
Description
adWATCH - AE is a solution designed to aid pharmaceutical companies in handling and documenting adverse events that arise during clinical trials. It provides a quick and efficient way for reporters at clinics, hospitals, or investigative sites to create and oversee Adverse Event Reports (AERs), ensuring proper reporting to regulatory bodies and government organizations. An adverse effect refers to a harmful or undesirable reaction experienced by a patient due to medications or medical devices. The process of documenting adverse events necessitates thorough tracking of all medical complaint case details, which culminates in the creation of MedWatch reports, CIOMS reports, and other management documentation. With adWATCH - AE, researchers, physician investigators, Contract Research Organizations (CROs), clinical trial experts, and various health professionals can easily generate and submit AERs in compliance with FDA requirements, adhering to both MedWatch and CIOMS formats. This streamlined process not only enhances regulatory compliance but also improves patient safety oversight during clinical trials.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Citeline
Country
United States
Website
www.citeline.com
Vendor Details
Company Name
Atlant Systems
Website
atlantsystems.com/atlant/solutions/atwatch-ae/
Product Features
Product Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
