QUALITY ASSURANCE
Can you give us some background about yourself? I’ve been working in quality assurance (QA) for over 30 years now. My career has allowed me to work in large and small sponsor/biotech companies and clinical research organisations (CROs). On top of that, I’ve worked for more than 10 years as an independent consultant before returning to the biotech industry. I’m currently working at a small biotech, and have been there for just over a year.
When should we involve QA when moving between vendors? Your QA should already be part of the escalation process, so if there are any issues with a vendor, we should know about it already – it shouldn’t come as a big surprise to your QA. Make sure that QA are involved right at the start of any process where vendors are involved. One thing you will see is that moving to a new vendor while your study is ongoing actually requires the same, if not more, input from your QA department. I would advise you to always consult your QA for their timelines and requirements before making the move to a new vendor.
What are some of the main issues you see behind biotechs wanting to move to a new vendor?
One of the questions that I ask the study team is: why do we need to move? Is it always about the vendor we’re working with or is it about us, our company, or other subcontractors, too? Before deciding to move, we need to first examine ourselves and see if we are the problem. There’s always the perception of the grass being greener on the other side, but is it truly, or is that just the perception? The other thing I see is urgency, which is often a factor behind the perceived need to move vendors.
“Urgency is what causes people to jump ship without a life jacket in the middle of rough seas and then wonder why they drowned. Moving to another vendor in the middle of the study could result in trouble.”
What questions do you advise sponsors ask themselves before moving vendors? The first thing I’m going to ask you about is your planning. How are you going to move vendors quickly when you took months to set this study up? You spent time carefully assessing and selecting your initial vendors. Sponsors cannot expect to quickly change vendors mid-study and expect processes to be all set up and running smoothly in no time at all. When thinking of moving vendors, initially look internally at yourselves: were you clear enough in selecting and setting up with your current vendor? When you say that the current vendor isn’t doing what you expected them to do, is it really all about them or did you not give them clear, detailed, unambiguous guidance? If you move, how are you going to improve or change that process to avoid a recurrence? It’s important to ask if you are actually going to improve things by moving, or could you not work with the current vendor to make that improvement? The other thing that we are often asked about in clinical trials is budget, and sometimes it costs a lot more to move to another vendor than to go back and fix the problems with the vendor that we already have. So rather than going to a brand-new set of people, in a brand-new relationship, with a brand-new vendor, is it not better to spend that money to look at why we went wrong in the first place, and could we not improve that? What else could we improve on? Communication, oversight, and teamworking could be considered before ‘jumping ship’.
Could you elaborate more on the ‘urgency’ factor behind people wanting to move? Urgency is one thing you see that causes people to jump ship without a life jacket in the middle of rough seas and then wonder why they drowned. Moving to another vendor in the middle of an ongoing study, without using the infrastructure that you had in place to choose the original vendor, could result in trouble. You just end up firefighting, and you’re more likely to fail because you’re not using your controlled environment. So the question I always ask people is: is there a true urgency? For example, if a vendor really cannot provide what you need in a timely manner that will compromise patient safety or data integrity, then yes, that’s a true urgency. If there’s nothing you can do about the
Outsourcing in Clinical Trials Handbook | 13
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100
