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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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

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 No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management No 

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