Service Introduction

1. 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

2. Implementation Plan

Having clearly understood, defined and together signed off your requirements, we will prepare an implementation plan which will list all the required activities and the time required for completion.

This would typically include:

• 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”

3. 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 will vary according to product and service requirements but might include:

• Service review(s) post “Go Live”
• 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

4. Database 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

5. Information 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 be required to check that the information is up to date

6. Team 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).

“Training tailored to requirements.”

This will be followed by an assessment to ensure all the key information has been understood.

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

7. Service “Go Live”

With 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.

8. Service Review

With the medical information service now in operation for your organisation, scheduled joint reviews will assess 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