By: Margaret Schubert, Sr. Investigational Product Specialist, Compliance Specialist, Cato Research
What if you were looking for a new pet? Would you simply go to the internet and pick out the first one that came up in an internet search? No, of course not. There are thousands of types of pets and different breeds and all have different qualities and personalities.
The same principles that guide finding the perfect pet should guide the choice of the best fit in an Investigational Product (IP) vendor. There are literally dozens and dozens of Investigational Product packaging and distribution vendors in the US alone. Some of these vendors are large “one-stop” shops and others are smaller and more specialized. The landscape is constantly changing too, what with company mergers and buy-outs, larger companies splitting off various service functions and staff moving from one company to another on a frequent basis. How do you choose the best one for your clinical trial project?
First step: do your homework – dog, bird, snake?
You would ask friends, relatives and colleagues about their pets, but you wouldn’t just ask them “what kind of pet do you have and do you like it?” You would go into much more depth. You’d ask things like – what do you like or not like about it? How does it mesh with your personality? Your way of life? How much did it cost and what does it require for maintenance? And finally, how easy is it to live with? You’d also do some internet searching for the perfect pet-fit.
Talk to everyone you know in the industry and people you meet at conferences and see who they have used in the past. Don’t just ask who they have used, though, a few pointed questions will give you much needed information:
- What kind of project – blinded? vials, bottles, blisters? How large? How does it compare to what you are planning?
- What kind of product?
- Customer service and communication – what kind of challenges did they face and how were they resolved (or not)?
- Timelines – how well did they meet your timelines. What were delays and why?
- Cost issues – unexpected costs, project delay costs
- Overall quality of service and deliverables
You can also find IP vendors through a web search or by meeting vendors at conferences. Check out their promotional materials and websites to be sure that they can (at least on paper) meet your needs.
Assess the needs of your project and compare the information gained to the specific needs of your project, particularly if you have some specialized needs like temperature considerations, highly toxic compound, a very large or very small project – all of these will need to be factored into your decision.
Okay, it’s a dog I want. More homework!
When you’ve narrowed down the dizzying variety of pets available to just a few breeds of dogs, you might start asking some more pointed questions – it’s time to dig a little deeper and the same is true when looking for vendors.
You’ll need to do some due diligence of your narrowed field of vendors. You’ll need to get confidentiality agreements in place before you can go much further. Then you should consider sending along a vendor questionnaire, which will act as an informal, remote audit. Though not a true replacement for an on-site audit, these can give you a better feel for how the vendor operations. Many vendors will be happy to send along their audit packet as well.
A Beagle, that’s what I want. Looking for the best-fit Beagle…
You’ve decided a Beagle is the dog for you. Now you have to find the perfect one. Large or small, breeder stock or rescue? It’s time to get serious about the final contenders. You’ll need to do the same with your vendor list.
By now you should have just a few vendors that you feel might be able to meet your project needs. Send a Request For Proposal (RFP) to two or three of them so that you can compare costs and services. Make sure that your RFP is detailed and comprehensive – the better your RFP is, the better the quotes you receive back will be.
When you get the proposals back from your vendors, you’ll discover that you don’t have apples and apples, but rather something that looks more like a fruit salad. All the vendors have different ways of presenting their services and costs. A spreadsheet can be very helpful here – comparing bottom lines doesn’t really work. Remember to make sure they provided comprehensive costs for all of the services you requested in your RFP, and realize that cost might not be the only deciding factor. Do you just buy the cheapest Beagle you can find, even if it has a nasty temper?
Maybe I should foster the Beagle for a few weeks before I buy.
You should definitely go meet that Beagle before you buy it. An on-site audit is almost always recommended before you send your product to a facility. It’s only by actually setting foot (or a contracted auditor’s foot) in a facility that you can truly evaluate their capabilities and Good Manufacturing Practices (GMP) compliance.
Your dog is such a perfect fit for your family! Where did you find her??
Okay, so finally finding the perfect IP vendor for your project might not be quite as exciting as finding the perfect furry partner for your family, but the rewards are reaped in the cost savings and efficiency with which that portion of your project will be carried out. You definitely don’t want to have buyer’s remorse in either case.
You shouldn’t go wrong as long as you remember to first research your needs, then research available vendors and their capabilities. As you’re able to narrow the field by ruling out vendors that do not suit your needs, you’ll be able to drill down to find the one that feels like the best fit. And then pay it back by telling your colleagues about your experience when it’s their turn to find an IP vendor.
It can be quite a process selecting IP vendors and managing the development of your product. Cato Research has a full range of Investigational Product management services, from vendor selection and auditing through IP planning and management. Feel free to contact us for more details.