Argint International

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Argint International Clinical Research and Development Services (Argint) is a privately owned regional CRO, providing clinical research services throughout Europe, but with a primary focus on Central and South Eastern Europe (CEE). Argint is focused on providing tailor made full-service solutions to small and medium sized biotech companies, partnering clients as they bring their drug candidates or devices into the clinical phase. Argint supports the planning and execution of our client’s development programs: from initial consultancy through phase I, POC and larger phase II and phase III studies

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http://www.argintinternational.com
Type Private
Industry Pharmaceuticals
Founded 2006
Slogan Your Study is Our Study. Your Risk is Our Risk. Your Success is Our Success.
Headquarters 22 Boloni Gyorgy u. Budapest, 1021 Hungary
Key people Agnes Pinnel

CEO and Co-Founder Steve Dobbin COO and Co-Founde

Number of employees 51-200 employees

History

Argint supports the planning and execution of our client’s development programs: from initial consultancy through phase I, POC and larger phase II and phase III studies. We provide a ‘one-stop shop’ for all clinical outsourcing needs in Europe. Their clients enter into a single contract with Argint and the clients construct the most suitable team to deliver the study they are planning from specialist vendors and manage the study for them, and with them, as their European partner.

A CRO for Small and Medium Sized Biotech Companies. Argint International Clinical Research and Development Services (Argint) is a privately owned, regional CRO, providing clinical research services throughout Europe. Argint is focused on providing tailor made full-service solutions to small and medium sized biotech companies, partnering clients as they bring their drug candidates or devices into the clinical phase.

Argint supports the planning and execution of their client's development programs: from initial consultancy through phase I, POC and larger phase II and phase III studies. Argint provides a "one-stop shop" for all clinical outsourcing needs in Europe. Clients enter into a single contract with Argint and then construct the most suitable team to deliver the study they are planning from specialist vendors and manage the study for them, and as their European partner.

services

Clinical

  • Consultancy
  • Feasibility
  • Project Management
  • Monitoring
  • Phase I
  • IT: Collaborative Study Platforms

Regulatory

  • Regulatory & Ethics
  • Legal Rep in EU

Data Management

  • Biostatistics
  • EDC
  • Medical Writing

Central Laboratory Services

  • Central Safety Laboratories
  • Cardiac Safety Laboratories
  • Central Respiratory Laboratories
  • Imaging Laboratories

Medical

  • Pharmacovigilance
  • Medical Monitoring

QA/ Audits

  • Argint's SOPs
  • Quality Assurance

Training Argint have entered into a strategic partnership with Brookwood International Academy

Pharmacovigilance

Argint's chosen partner for pharmacovigilance services is ProductLife UK Ltd.  Argint has a proven track record of collaboration with ProductLife over many years and they subcontract their PCV services for clients as needed. 

Services include:

  • Maintenance of the product safety database (fully validated safety database system which is E2B and 21 CFR Part 11 compliant)
  • Individual Case Safety Reports processing for Serious Adverse Events (SAEs)
  • Medical Monitoring and Medical assessments of SAEs
  • Full Serious Adverse Event case management (SAE processing, SUSAR submissions)
  • Developmental Safety Update Reports (DSURs)
  • EudraVigilance registration and maintenance
  • Un-blinding and global regulatory reporting
  • ICSRs, monthly line-listings, annual safety reports and periodic safety update reports

Medical Monitoring

The Medical Monitoring Plan provides a comprehensive review of procedures and practices to be conducted by the Medical Team during the course of the study.  Medical monitoring ensures that medical data generated from the trial are valid and reliable, and the early recognition, identification and reporting of issues impacting on patients' health and well-being are maintained for the duration of the trial.

The role of medical monitor is divided into two distinct functions: proactive and reactive medical monitoring.  

Argint's own medical personnel assume the 24/7 reactive medical monitoring function.  Argint assigns experienced physicians to the study team and calls from investigators relating to the protocol, procedures, eligibility or safety issues are directed to the assigned Argint study physicians.  Received calls are directed to the physicians assigned to the study who are both familiar with the study and the indication.  Questions related to predefined issues are escalated to the client as agreed and as defined in the Medical Monitoring Plan.

ProductLife UK Ltd., Argint's chosen partner for medical monitoring support, provide the proactive medical monitoring service which includes:

  • Review the eligibility requirements and any violations
  • Review of safety signals
  • Review of Frequently Asked Questions (FAQs)
  • Monthly review of all AE's in a study and perform on-going safety trend analysis and signal detection
  • Monthly review of all SAE’s in a study and perform on-going safety trend analysis and signal detection
  • Review laboratory listings and other trial data to identify safety risks ensuring compliance with actions recommended in the protocol

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References

  1. http://argintinternational.com/
  2. https://www.linkedin.com/company/argint-international

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