Pharmacovigilance

The pharmacovigilance department provide a comprehensive suite of outsourced services to ensure compliance across the full lifecycle for a broad range of product types.

 

Our in house QPPVs and operational team provide a safe-haven for your safety data and we help our clients to remain in compliance and manage their commitments to monitoring patient safety.

We use a fully validated and industry standard ARISg™ database and we have the flexibility and capability to scale our services for small clients with a single clinical trial, through to global multinationals with marketed products that create high case volumes requiring 24/7 support.

We provide the following services:

  • Post market PV
  • Post market medical information
  • Clinical trial PV
  • Medical device vigilance
  • PV documentation
  • PV auditing and training
 

Post Marketing Support

Our experts provide full pharmacovigilance support for products including generics, innovator products, advanced therapies. Led by in-house QPPVs and a team of experienced professionals, can flex to meet the medical safety needs for an extensive range of product portfolios and provide the following services.

  • QPPV services
  • 24-hour Pharmacovigilance cover
  • Support for EU companies with no presence in UK & Ireland
  • Medical Information service
  • Electronic management of Adverse Event reports on the ARISg™ database
  • Electronic expedited reporting (EudraVigilance)
  • Literature Search and Reviews
  • Signal detection
  • Periodic Safety Reports (PSURs)
  • EudraVigilance set up and oversight
  • Risk Management Plan (RMP) writing.

In addition to these outsourced services, we also help our client’s internal teams by carrying out auditing of their PV systems and by providing PV training.

 

Clinical Trials & Speciality

Ensuring that patient safety is evaluated in the clinical setting requires scalable Pharmacovigilance coverage to meet the evolving needs of the Sponsor. Our team specialise in providing bespoke PV solutions for challenging clinical programmes by providing the following services:

  • Global drug safety project management
  • Reporting of serious adverse events to Competent Authorities, Ethics Committees and investigator sites
  • Responsible person for EudraVigilance
  • EudraVigilance set up and oversight
  • Preparation and distribution of DSURs
  • Management of pharmacovigilance for global clinical development programmes
  • Electronic management of Adverse Event reports on the ARISg™ database
  • Electronic expedited reporting (EudraVigilance).

In the clinical setting the team have experience in meeting the needs for named patient supply and compassionate use. Our team have expertise in the reporting requirements for Advanced Therapies with broad experience in this niche area.

 

Medical Device Vigilance

The regulatory landscape for medical devices has undergone significant change, but our team can provide a robust solution for your medical device vigilance programmes by providing the following services:

  • Device Vigilance Project Management
  • Collection and follow-up of Medical Device Incidents
  • Weekly literature searches of Medline
  • Electronic management of Incidents on the ARISg™ database
  • Expedited reporting of Medical Device Incidents to Competent Authorities
  • Distribution of Field Safety Corrective Actions and Field Safety Notices.
 

Auditing, Training and PV Systems

Our team provide a range of services to assess the performance of pharmacovigilance departments and to put in place plans for continued improvement. Services include:

  • Pre-inspection preparation and planning
  • Provision of audits to monitor PV department performance
  • Procedural gap analysis and provision of recommendations for continual improvement
  • Staff training
  • Quality systems review.