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Service Introduction

Our process

Working in Partnership to Enhance Patient Care

Here is an overview of our Medical Information implementation process, explaining our 8 steps from understanding your requirements through to launch and review.

Click the sections to the left for more information

Working In Partnership to enchance patient care Database Setup Information Collation
Implementation Plan
Service Requirements
Information Loading
Service Go Live
Service Review
Team training
01 Service Requirements   
 Working together, we will discuss and define your requirements for the provision of Medical Information by PrimeVigilance. We will need to determine:
  • The number of products you require medical information for and the countries where these products are available
  • The business hours and time zones you require the service to be available and if a 24 hour service for 365 days a year is required
  • The level of information that is currently available to answer the requests
  • Who will maintain the current information going forward and who will create new information documents to address enquiries not previously received
  • If in addition to healthcare professional and patient enquiries, there is a field force to support for medical information
  • When you need the service to go live
02 Implementation Plan  
Having clearly understood, defined and together signed off your requirements, we will now pull together a plan of how we will implement the medical information service for your organisation.

The implementation plan will list all the activities and time required to complete those activities:

  • Compiling the product information and documents
  • Creating and setting up the database for your organisation
  • Loading the product information into the database
  • Database testing and validation once set-up and information loading has been completed
  • PrimeVigilance Team training on your products
  • Service “Go Live”
  • Service review(s) post “Go Live”
03 Information Collation 
This time in the plan is for you and your organisation to collate all the necessary information on your products which you will provide to PrimeVigilance to allow us to effective manage your medical information enquiries. This information would include, but not limited to, the following:
  • Standard Letters and Frequently Asked Questions (FAQs) currently used to answer medical information enquiries
  • Patient Information Leaflets (PIL)
  • Summary of Product Characteristics (SPC)
  • European Public Assessment Reports (EPAR)
  • Literature References quoted in Standard Letters and FAQs
  • Data on File quoted in Standard Letters and FAQs
  • Product Safety Data Sheets (SDS)
  • Product Formulation and Stability information
  • Copy of all product packaging
04Database Set-Up 
This time in the plan is for PrimeVigilance to set-up the call centre system and database so they are configured to receive and record medical information enquiries on your products

This would typically include:

  • Setting up your organisation in the database
  • Creating your products in the database and assigning to your organisation
  • Creating “read access” to the database for you so you are able to access the information PrimeVigilance is capturing on your behalf
  • Assigning the PrimeVigilance staff to your medical information service
  • Setting up service reports based on your requirements
05Information Loading 
With all the product information collated and the PrimeVigilance medical information database set-up and configured to your requirements, we now load all the product information into the database.

If necessary, we will reformat all documents before loading, to ensure the documents are correctly formatted and spell-checked to ensure a professional look to all written replies. Once all the product information is loaded, we will undertake validation testing of the information and database, ensuring everything has been created and loaded correctly

The time taken to load the information will depend on:

  • The number of products and the volume of information available for each product
  • The quality of the information
  • Whether the existing information conforms to your organisation’s letter formatting
  • Whether we need to update the information as the information is out of date
06Team Training 
With the database now ready, the PrimeVigilance team are trained on your products and the product information provided. 

Team training will take the form of classroom delivered training on your products and the wider product disease area(s).
This will be followed by an assessment to ensure all the key information has been understood.

“Training tailored to requirements.”

The time taken to train the medical information team will depend on:

  • The number of products and the volume of information available for each product
  • The complexity of the product
  • The level of medical information service being provided
  • The number of countries being supported and the Regulatory requirements in those countries
07Service “Go Live” 
medical-information-service-goliveWith the Implementation Plan now fully executed, we are ready to go live with the medical information service for your organisation.

The PrimeVigilance Medical Information team are ready and waiting to commence answering enquiries on your products from healthcare professionals and patients.

08Service Review 
With the medical information service now in operation for your organisation, together we sit down and review how the service is working and where improvements could be made:
  • Number of enquiries being received
  • Nature of the enquiries
  • Number of Adverse Events and Product Quality Complaints by Product
  • Percentage of enquiries unable to be answered with the information provided to PrimeVigilance
  • Number of enquires being received outside of normal business hours

“Working together for continuous improvement.”