Partnering with a Medical Information services provider is a great way for you to focus your limited resources on key areas of your business. However, it’s important to give due consideration – as early as possible – to how the service will function.
Transferring intellectual property you have accumulated over time to a group outside your organisation is a big undertaking. Consideration of our top 5 – even before you have engaged a Medical Services consultancy – will help to ensure your Medical Information transition is seamless. Selecting an experienced and proven Medical Services provider will also make the process much less complex.
Consider the service and enquiry demands to be outsourced:
- Do you want your Medical Information (MI) provider to deal with all or part of your product range?
- What is going to be the demand per day, per month?
- What is the split between products and frequently asked questions?
- What is the split between AE reports, PC’s?
- What is the enquiry mix – simple verbal or more complex written responses? And what will be the process for managing these?
2. Enquiry management
Review the processes required to receive and respond to issues, and their escalation:
- What will the mechanism be for incoming enquiries and outgoing responses?
- Do you need to involve your IT department in telephone call routing, permissions to email boxes and CRM access?
- Who, in your organisation, will be responsible for any issue escalation?
3. Data management
Determine how data is going to be collected:
- Will you need to train your MI provider in the use of your company’s global or local Medical Enquiry Database or does the provider have a CRF21 Part 11 validated MI database that could be used instead?
- Are there security and IT considerations such as unique user ID and logins?
- Providers may have systems that could improve your current compliance so explore these options early.
4. Dealing with AEs and PCs
This aspect of MI can be complex and needs to involve Drug Safety and Quality personnel at the outset:
- Ensure your MI provider will be flexible in how they report and collect information.
- Will your adverse events/complaints involve complex data exchange via IT gateways, direct entry in local or global databases or paper based lodging?
- Does data for transfer need to be encrypted?
- Do RMP commitments need to be implemented such as tailored questionnaires or special event monitoring?
5. Project Management
Consider what service levels and key performance indicators you want to mandate:
- Be sure you convey and document your compliance requirements at the beginning of the service and monitor them through scheduled reports and formal service reviews.
- Who will be responsible for supporting the MI provider when required, especially in the early stages when they don’t yet have the relationships or working knowledge you do?