Michael Chambers recently found this article, posted as a blog a few years ago, by Dr Jonathan Hare, when he was VP, Research at Kingfisher International Inc. It rang true for us, so we thought it was worth reposting here, or follow the link to the Kingfisher Website for more information.
TEN YEARS AT A VETERINARY CRO AND 10 LESSONS LEARNED!
February 25, 2014
Kingfisher International Inc. celebrates ten years in business this year. It’s been an amazing ride. Both the most stressful and fulfilling time in my career! Here’s some take-homes I’ve learned:
1. Plan for success but anticipate failure. The projects we do in regulatory science can be complex and difficult. When things go well and the sponsor gets the outcomes they expect, the scrutiny on your data is much less than when studies go awry. By continuously having the worst case scenario in the back of your mind, you’ll be anticipating the deep drill that invariably occurs with unexpected results. This is the true test of your documentation and data integrity.
2. The relationship with the sponsor is personal. In our business, branding is illusory. Sponsors are choosing you to do their project because of your scientific acumen, organizational skills, communication style, written skills, sense of humour… whatever! Price may be a determinant as a relationship starts but in my experience quickly gives way to the less tangible parts of the relationship. Almost always the relationship is between two people: a Study Director/Investigator and a Sponsor Rep. The Sponsor Rep is entrusting me with a chunk of their career. The unspoken objective is that I need to make them look good in front of their boss. That’s personal!
3. Identify solutions, not problems. Our work is hard. If it was easy, everyone would be doing it! Deviations happen, some are no biggie, some are catastrophic. But you can’t be the proverbial cat leaving a dead mouse at the doorstep of the sponsor! If you are the person to identify a problem, then you are uniquely qualified to make a first stab at the solution. Take ownership of problems.
4. Set deadlines and exceed them, always. Time activate your life. I have a task list with, on any given day, 50 or so items on it. I know when all of them are due. I have negotiated the deliverable timelines and have built in buffer so I can over deliver consistently. If circumstances change, I try to re-negotiate the timelines well in advance. Use task management software. Get rid of the sticky notes.
5. Don’t be afraid to be the dumbest guy/gal in the room. Ask questions. In all things seek crystal clarity. Re-iterate your understanding of confusing points. Stop the conversation and go back. If you are a Study Director, it’s all about you knowing what is going on. You have to get your arms fully around the science and the project.
6. QA is important, but poor QC will keep you up at night. Poor QC, even generally good QC with one or two slip-ups, can completely undermine your credibility as a CRO! Your sponsor should not be finding QC errors in your data. Make sure your internal processes are bullet-proof. Find people with a penchant for mind-numbingly repetitive tasks to do QC for you. Your QA is often NOT well suited to this task.
7. You have to know how to write. We work near Toronto which is an amazingly diverse city that has attracted brilliant scientists from all over the world. We are fortunate to have an amazing talent pool. Inevitably, English is not everyone’s first language, and even when it is, not everyone is Philip Roth or even JK Rowling! Spelling and grammar count. Formatting counts. Concise, lucid prose is the goal. Always have someone proofread internally.
8. Encourage sponsor audits and monitoring visits. They can’t tell how your team and quality systems work from your website. Having their buy-in to your quality systems prior to study start is vital. During the study, if they are physically present if issues crop up, they can assist in ensuring that things or dealt with, amendments are approved, and they can personally attest to the “out-of-the box” thinking you used to sort things out. Never forget, however; that as a CRO, your job is to make the Sponsor’s visit as boring as humanly possible!
9. Study deviations are not to be feared. As a CRO, you need a culture that, while not encouraging deviations, encourages their reporting. Most will be minor and of no impact. Some just show that you were paying attention to the protocol! Document them, assess the impact, and move on. Personally, I am very wary of subcontractors that tell me they conducted their part of the study without deviations. We’ve never done a GLP or GCP study without ‘em.
10. Be picky about external “experts”. Occasionally we need to go outside the lab to involve specialized scientists in our projects. Make sure they are committed and can deliver. A senior father-figure in the vet CRO world once told me that “competent experts are a dime a dozen, those who can DELIVER, are very rare indeed!” Ensure they have basic training on the regulatory framework you are operating under. And, most importantly, make sure they “stay on the reservation”. We routinely assign a technician to shadow them when they are in the lab, ensuring they stick to the protocol, document their findings properly, and complete their paperwork.
Jonathan Hare is VP, Research at Kingfisher International Inc. a CRO exclusively dedicated to the advancement of veterinary product development through good science, quality processes, and dedication to animal welfare.
Link to the article: https://kingfisherint.com/hello-world/
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