Winter 2006/07
ACDM College Week: CRO/Pharma Interactions
I attended the half-day ACDM training course CRO/Pharma Interactions which was run for the first time on 16 November 2006 by Jon Wood from Pfizer.
The ACDM College Week flier described the course as:
"This half day course is designed for Data Management Professionals with at least 2 years’ experience in Clinical Data Management who are involved from either side in CRO/Pharmaceutical company collaborations. Through interactive presentations, you will discuss Pricing Models, Contract Development, Service Agreements, Relationship Building and Maintaining and Resource/Task Split”.
The training was run as a hands-on discussion group where all delegates were encouraged to participate fully. The delegates consisted of representatives from major Pharma companies, CROs and some people like me who did not fall neatly into one of the categories (DM from a Phase I unit), providing an ideal mix.
The discussion topics consisted of the following sections – Outsourcing Drivers, Key Factors in Partner Selection, the Contracting Process, Performance Management and Relationship Models.
The section on Outsourcing Drivers explained the current industry trend to outsource more work in an attempt to reduce costs and time getting drugs to market.
In view of this, the choice of CRO partners becomes critical to pharmaceutical companies and this topic was discussed in the section Key Factors in Partner Selection. Many pharmaceutical companies have a selection strategy, but if not, they were encouraged to develop one. This might be to use a single CRO for all services or multiple CROs to provide different services, but definitely to define what business was best to keep in house and outline the reasons for that decision.
The Contracting Process covered the different types of relationship which can be employed between CROs and pharmaceutical companies, what relative risks and profits may be incurred in partnership, alliance and basic consumer-supplier contracts. Request for information, request for proposal and bid defences were discussed along with pricing strategies. Letters of intent, master service agreements, work orders and change orders were defined and discussed, stressing the fact that these should be clearly defined, so scope changes can be agreed by both sides without conflict.
Performance Management discussed how issues should be dealt with, without compromising the relationship between the CRO and pharmaceutical company.
Relationship Models were concerned with deciding the optimal arrangement between the CRO/pharma. This can range from an ad hoc arrangement through preferred supplier to strategic relationships. The latter was of great interest to me as the Wyeth/Accenture long-term strategic relationship was discussed and having worked at both Wyeth and Accenture during the time the alliance was formed, it was interesting to see an outside perspective.
In summary, this course provided a huge insight into the differences and similarities that exist between CROs and Pharmaceutical companies – the joint result of which should be to provide flexible, timely, quality and cost efficient Data Management services. Jon’s background covers both CRO and Pharmaceutical industries extensively and he proved to be an interesting, informative and knowledgeable trainer.
I would recommend this course to anyone who participates in a CRO/Pharma environment, to get the best out the relationship between a CRO and pharmaceutical company, irrespective of which side of the equation you find yourself. It provides a lot of information for a relatively low cost and would be suitable for data managers of all experience levels.
Vicky Wiggins
Manager Data and Statistics, Clinical Research Centre