CS-SAFETY 

PHARMACO-VIGILANCE DATABASE

DRUG SAFETY APPLICATION

Clinevo Safety is a cloud based, user-friendly, easy to use, regulatory compliant end-to-end Pharmacovigilance / Drug safety system. All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety Signals capabilities under one platform.

Patients' safety is given prime importance for ongoing medical support at the site. Serious Adverse Events and Adverse Drug Reactions are all monitored, documented and reported within the defined timelines. Our team consists of several Physicians and Doctorates in Pharmacology with experience in Pharmacovigilance practices for trials across a wide array of therapeutic indications.

  • Providing medical monitoring/support to sites

  • Serious Adverse Event (SAE) Management

  • Assessment of Causality and Expectedness of Adverse and Serious Adverse Events

  • Preparation of Alert letters

  • Medical Writing Authoring of clinical study documents (Protocol, Investigators Brochure, Summary reports and Publications and authoring of medical communications

  • Our team consists of several Physicians and Doctorates in Pharmacology with experience in medical writing for trials across a wide array of therapeutic indications

 

CSafety consulting and Implementation services

  • Implementation and customizations

  • Validation

  • Data Migration

  • Upgrade

  • Hosting / Cloud computing

  • Maintenance and Support

  • Oracle Partnership and Oracle Certified/Specialized team

  • ICSR Processing

  • Training

ONE PHARMACOVIGILANCE SOFTWARE

CS safety is  Pharmacovigilance database / Drug Safety Database includes PV Intake, Case processing, Submissions, AI & Analytics, and Safety signals

 

LOWER TCO AND EASY MAINTENANCE - Built on simplified technology stack which provides a lot of configurations and less customizations

 

CASE COMPLIANCE ALERTS - Provides end user alerts for cases nearing due dates

 

AI & AUTOMATION -  Advanced Automation & AI features to lean case processing efforts

 

DYNAMIC WORKFLOWS - Consists of easily configurable dynamic workflows for expedited case processing

 

FASTER USER ADOPTION -  Business team, CROs, and others can be trained on the Pharmacovigilance database / drug safety database within few hours of time

ADVANCED ANALYTICS -  Provides powerful and actionable insights

 

ANYTIME, ANYWHERE & ANY DEVICE - User friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers

 

REGULATORY INSPECTION READY-  Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

 

In summary, CS safety Provides, 

  • transparent optimized pricing with no compromise in functionality, 

  • High performance and efficiency, 

  • built on a secured regulatory complaint infrastructure,

  • works towards reduction of end user efforts through constant automation and AI capability enhancements.