How would you describe PCMG to someone in no more than 20 words?

“A unique, member-driven association identifying and advocating best practices in Clinical outsourcing.”

What attracted you to join PCMG as a member and how did it happen?

“I found it online in 2000 and attended a workshop in 2001 – I became a Committee member the same year and the rest is history. The initial appeal of joining was to add leverage to my name and my company in dealing with CROs. I was also keen to know what were best practices, standard procedures, quality standards, industry norms etc. It very quickly became an excellent network of like-minded people working in similar roles, who were a brilliant source of support and information and have remained friends today.”

What benefit did you gain from joining the committee?

“Gaining knowledge from formal and informal sources. Over the years, I’ve amassed a huge amount of information and learning, including genuine insights into risk reduction and design structure of outsourcing functions. Knowledge of the market, tips on good service providers, particularly smaller CROs providing specialist services. It was also tremendous reassurance that I was doing things right, and I’ve gained some leverage with CROs I’m sure. Being involved in fabulous workshop events for deep learning. Also, the templates were excellent for the time in the early stages of PCMG.”

What experiences weren’t you expecting before you joined the Committee which proved useful in the workplace?

“The get-togethers in the early days were terrific – all about networking and forging good working relationships. Being able to network with colleagues from small, medium and large companies and getting a great insight into how outsourcing was working in the different companies has benefitted me hugely. I was able to see the evolution of outsourcing strategies and practices and pick the best bits to bring back in-house. The most important thing was possibly gaining a deep insight into the outsourcing language around the legal terms and contractual rigor. I also learned a lot about regulatory requirements, and in particular, I gained an awareness of the enthusiasm of the regulators to audit in particular the outsourcing function. PCMG was instrumental in helping me see which quality requirements were necessary to satisfy the regulators, and of the need to be inspection ready. I would not have achieved successful regulatory inspections without my PCMG engagement.”

How has membership of the Committee changed your working perspectives?

“I have worked in CROs in the past, so I believe I have a very good perspective on the CROs business model and business goals from that. I guess my perspectives on the importance of having robust and practical quality platforms has changed, because I’ve learned the importance of staff being able to follow them 100 percent day-to-day to enable my company to be inspection ready. I also appreciated that, when reporting upwards to the Board, my membership of PCMG was perceived as a benefit in reducing the risks of our operations. The Board were reassured that I had implemented an outsourcing platform that was efficient and effective, that there were less likely to be any nasty surprises, and that the shareholders were getting a good return on their investment. PCMG membership and engagement reduced the risks of our products not getting to market, hence increasing future discounted cash flows, and therefore increase the value of our assets under development. Can I quantify that? Unfortunately not.”

What are the major changes in the outsourcing landscape that are affecting members of PCMG?

“Decreasing power and authority of the outsourcing role generally. Increasingly sophisticated and skilled CRO business development teams and negotiators. The simple business model of the CRO versus pharma is also affecting PCMG members.”

What piece of advice would you give someone considering putting themselves forward for a place on the PCMG Committee?

“Membership of the Committee will raise your professional and personal profiles within the industry, outsourcing and CRO alliance communities. It will facilitate the perfomance of your day job, through greater knowledge and awareness and greater appreciation in the service sector of who you are and what you represent. You will become deeply embedded in the world of outsourcing, with a chair at the top table within the industry.”

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