ECRON ACUNOVA
 
 
 
Pharmacovigilance
 

Pharmacovigilance

 
   
Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. It is a key public health function (European Commission).

The Pharmacovigilance department of  Ecron Acunova have the expertise to undertake this challenge. We meticulously collect from patients and healthcare providers all information concerning the safety of medicinal products that have been entrusted to us, either in developmental phase or post-marketing. . We constantly assess these data and determine the best possible risk minimization measures, in accordance with regulatory authorities.
 
     
     

Ecron Acunova Expertise



Our team consists of dedicated, skilled, and experienced physicians, life science professionals and other clinical professionals experienced in drug safety. Broadly categorized, our services encompass safety management, regulatory reporting and post-marketing surveillance, as well as technology support.

Adapting our services to sponsor‘s needs, we provide all the necessary pharmacovigilance services, both during and after the clinical trial.

During the clinical trial, our services include:

  • Trial-related safety management plan
  • Drug safety coverage during a trial (24 / 7)
  • Training / briefing (in-house and investigators)
  • Regular medical monitoring
  • Reporting to sponsor (SAEs, Pregnancy, other significant events)
  • Handling of ICSR / medical review and clarification
  • Unblinding services
  • MedDRA coding
  • SAE-database (Oracle AERSTM)
  • Writing of case narratives
  • Generation of ICSRs in CIOMS-I form
  • Reporting of individual case safety reports to authority
  • Distribution of SUSAR/CIOMS-I reports to investigators and committees
  • SAE reconciliation (including solving discrepancies)
  • Generation of safety reports (DSURs and LL)
  • Distribution of safety reports
  • Safety chapter in trial report
  • Prepare literature reviews
  • Responsible Person for EudraVigilance
  • EudraVigilance reporting using EVWEB

Post-Marketing Services:
  • Signal detection and trend analysis
  • Risk evaluation and management
  • Individual Case Safety Report (ICSR)
  • Case Narratives / MedDRA coding
  • Pharmacovigilance Physician services
  • Case Reporting
  • Periodic Safety Update Report (PSUR) preparation and submission
  • EU Qualified Person for Pharmacovigilance (QPPV) and deputy

All our team is at least bilingual and speaks English. Other languages for our team in Frankfurt are German, French, Spanish, Arabic, Russian and Ukrainian.
 

We've got you covered around the world



Pharmacovigilance is assured at a global level through specialized agencies in different regions. In Europe, Pharmacovigilance is coordinated by EMA (European Medicines Agency) and the different national competent authorities. The FDA is responsible for coordinating these efforts in the US and the DCGI assures pharmacovigilance in India.

Ecron Acunova closely monitors these agencies, paying close attention to their development and to the latest regulatory matters. The challenge of standardizing processes worldwide in pharmacovigilance is in progress.

Pharmacovigilance support center



The Pharmacovigilance support center is setup with SIEMENS OpenScape Contact Center Enterprise.

This seamlessly and efficiently integrates Inbound Voice, Email, Web Collaboration, IVR Self Service and Callbacks into the Contact Center to professionally handle all the inbound contacts from our clients across the globe.

Our Communication Platform is provided by TATA Communication for cost-effective and high quality voice on Toll-Free numbers. IVRS can handle multi -language, intelligent queue announcements. Agents can also login from remote locations. This is a highly customizable workflow based system which is scalable to handle a high volume calls and agent size from LAN and remote locations.
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Pharmacovigilance
Ecron Acunova Expertise
We’ve got you covered around the world
Pharmacovigilance support center
 
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For further information, please email:
pharmacovigilance@ecronacunova. com
 
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