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Outsourcing PV: Selecting your Partner
Posted on January 23rd, 2017 by J.-P. Clement MD in Pharmacovigilance
Once you know what functions and expertise you want to keep in house and what are the PV activities you want to outsource, the next challenge will be to identify potential partners and pick-up the one which will fit your PV needs for the years to come.
Unfortunately, the process for selecting a PV service vendor often happens before a clear identification of what the company wants to keep in house as core competencies. Imagine yourself going to a car dealer not knowing if you need a pickup truck or a convertible, and not knowing which car dealer to visit, and you will understand the issue here. Too often, the selection of a PV services vendor will be done without due diligence, based on previous exposure with the vendor, or because it is driven by an influential stakeholder’s recommendation. Though it can work (sometimes), this is not the preferred approach for selecting a long-lasting partner. There is no such thing as blind-dating for PV services.
Knowing that the business of PV services has been booming over the last years, many providers have the experience you are looking for, but several others want to get into this market without the credentials you need. Due diligence and fact checking will help in making your decision.
These are a few items you should look at:
- Experience: look for a partner with more than a few years in the business, not only in the Pharma services, but more specifically in safety. Evidence of such activities is a must. The ability to contact a couple of existing clients to confirm the quality of services should be offered.
- Specific expertise: based on your core competencies, do you have a good match between all the activities you plan to outsource and the service offer? How many DSURs or PSURs have been generated by the vendor to date? Is the vendor familiar with EU GVPs and has a footprint in Europe? Is the vendor experienced with the complexities of the IND rule in the US or as a call center for medical information? There are many areas to look at.
- Quality and Performance: regulatory authorities are expecting a total (100%) compliance in expedited reporting and you should not ask for less (as long as it relates to what is in the control of the vendor). A limited but meaningful set of key performance indicators (KPIs) should be accepted with financial impact in case of deviation. The CAPA process used by the vendor in case of non-conformance should be transparent and accessible by the client. It often gives a great insight on what are the vendor’s strategy and practices on quality.
- Geo-location: large organizations need a 24/7 availability for processing cases and managing issues. A time difference that prevents timely discussion of case details can be frustrating. You should also be comfortable with dealing with groups trained in a different world region than yours, where medical terminology and medical writing practices may not totally blend with your own practice and expectations. Be clear if you need a locally based team or not.
- How big is your business for the vendor: will you be a minor or major client for the vendor (small fish/big pond or big fish/small pond)? Will you get all the attention and customization that you need considering other clients that the vendor is helping?
- Know your team: having a vendor service presentation is nice, but that is pretty much about it. The vendors will put their best team forward, but may allocate different resources/talents to your project. Knowing who will work with you in the long term and what governance model and escalation path will be used and will increase trust.
- Due diligence is key: if you have not had an experienced and qualified auditor to check that the vendor meets your criteria from functional (PV), financial and security (IT, offices, data) standpoints, there is a lot that you do not know about the vendor.
- Look at the proposal itself: the way it is written will be very informative on the comfort zone of the vendor to talk about safety activities, international PV regulations and complexity of the PV world. It will tell you much in terms of the vendor’s familiarity with the subtleties of signal detection activities and benefit-risk assessment. It will help seeing the supporting evidence of the vendor experience and where are potential red flags. Numbers matter a lot (cases processed, compliance rate, number of products managed) and should be available without reticence.
There are many checkpoints to verify to optimize the decision for a PV services vendor. Establishing a partnership of many years deserves time and methodology. Bringing internal/external experts in as needed to guide your selection can be extremely helpful. What matters here is to maximize the probability of success of a long-lasting partnership. It will allow you to reduce operational friction and maximize your energy and resources on your key strategic priorities: products and patients.
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All opinions shared in this post are the author’s own.
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J.-P. Clement MD
Executive Pharmacovigilance Consulting
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