Gap Analysis, Strategy & Training

Are you concerned that your current system is not fit for your company’s planned expansion in activities?  We can review your processes and systems, identify the gaps and recommend solutions.

Do you need to expand your pharmacovigilance activities outside of your home region, or perhaps develop a global solution in a rapid, cost-effective and compliant manner? We can design a system that can either interlock with your existing processes, or we can create the whole thing from scratch.

We train and oversee teams worldwide.  A cost-effective solution maybe to train existing employees or distributors to be part of the global solution. Or we can work with you to recruit new team members and provide contractors in some countries if required.

If you are aiming to bring in your own pharmacovigilance database at some stage, we can assist you to implement a cost-effective fully compliant solution.

Implementation Pre- and Post-Marketing

We don’t just design pharmacovigilance systems, but we can implement them for you.  We can oversee the process from initial report through to compliant submission to regulatory authorities.  Our case processing is performed cost-effectively in the EU, with oversight and Quality Management from our HQ.  We are experienced in submitting to most key health authorities worldwide. Most pharmacovigilance reporting globally can be conducted from our bases in the EU, UK and USA.

We can ease the load of aggregate reporting by writing the documentation for you and you may wish to consider our harmonisation solution where aggregate reports are drawn from multiple CRO sources.

Harmonisation across CROs

Many small to medium sized pharma and biotech companies ask their CROs to look after pharmacovigilance for them.  This can lead to your data being on multiple databases, subject to differing processes, levels of compliance and costs.  Aggregate reporting can be a challenge.

Problems can occur further down the line if you want to bring the database inhouse, the product is acquired, or you decide to move CROs.

We can bring all this together in your own database, or via a hosted solution which gives you full access and control.  We can do all the rest, including interacting with multiple CROs if necessary.

Safety Support during Clinical Development

We work closely with our Clinical Development team to ensure seamless delivery of services to support your clinical development program. We can provide safety support for your trials at all stages of clinical development, below are just some of the services we can provide, contact us to discuss how we can assist you:

  • Design of Serious Adverse Event (SAE) and Pregnancy reporting forms
  • Implementation of safety databases
  • SAE management from receipt to assessment and expedited reporting of SUSARs (Suspected Unexpected Serious Adverse Reactions)
  • Provision of Safety Physicians
  • Preparation, review and submission of Development Safety Update Reports (DSURs)

Safety Support for MAA and Beyond

If you are proceeding to Marketing Authorisation Application in Europe, you will need to have developed a Pharmacovigilance System Master File (PSMF) that describes how your system is compliant.  This needs to be hosted in the EEA for inspection purposes.  We can create this with you and host it for you.

We can also work with you on your Risk Management Plan (RMP) that is an essential part of the submission.

You will also need an EEA QPPV (Qualified Person for Pharmacovigilance) and local contacts/QPPVs throughout EU as required by national law.  We can source these from our network of experts and oversee them for you.

When your MAA is successful, you may have additional pharmacovigilance activities in the RMP.  We can plan these with you and oversee or conduct the implementation of those activities and help you design ways to evaluate their effectiveness.

Should you require support with all of your post-marketing pharmacovigilance activities we can provide this, ensuring that you remain compliant with the legal obligations of a Marketing Authorisation Holder (MAH). Below are just some of the services we can provide, contact us to discuss how we can assist you:

  • Establishing your global pharmacovigilance system
  • Provision of EEA QPPV and local PV contacts/ QPPVs
  • Provision of Safety Physicians
  • Assistance with the EudraVigilance registration process
  • Provision of Responsible Person for EudraVigilance
  • Data entry and maintenance of product details in the Article 57 database (XEVMPD)
  • Pharmacovigilance process gap analysis
  • Standard Operating Procedure (SOP) & Work Instruction (WI) preparation
  • Preparation, maintenance and hosting of the PSMF
  • Pharmacovigilance training
  • Preparation, maintenance and submission of RMPs
  • Implementation of safety databases
  • Individual case safety report (ICSR) management from receipt to expedited reporting
  • Literature searching services
  • Safety signal management
  • Risk minimisation activities
  • Preparation, review and submission of Periodic Safety Update Reports/ Periodic Benefit-Risk Evaluation Reports/ Periodic Adverse Drug Experience Reports (PSUR/PBRER/ PADER)
  • Preparation or review of Safety Data Exchange Agreements
  • Pharmacovigilance system, process and document audits
  • Support prior to & during pharmacovigilance Regulatory Inspections, including inspection readiness training
  • Corrective action/ preventive action (CAPA) preparation
  • Guidance & advice during integration of pharmacovigilance systems following company mergers/ acquisitions
  • Interim pharmacovigilance support during busy periods/ staff shortage

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