Pharmaceutical Technologist - May 2008 - (Page 24)

SMEs versus CROs SME to understand these things and to do everything it can to facilitate the delivery of the project within the timescales agreed, to the quality standards prescribed, and to provide something of value that propels the product further down the drug development pipeline. In the real world, the customer is not always right and to be successful in any project and to work together in partnership, there must, from the outset, be an understanding and transparent relationship within the project team. There must be a joint desire to see the project through to completion and, while not on paper, a feeling that the product is as much the CRO’s as it is the client’s. By bucking the obvious trend to be all things to all men, there is much to be gained from knowing exactly what you do and doing it to the best of your abilities. If the concept of customer care was to be distilled into one single word then it would be reliability. To make any comment on customer care, the SME must deliver what it has promised to the client. If customer care is to be a true differentiator then there must be an alignment throughout the business from sales to operations and administration. Understanding what the client is seeking to gain from the relationship, and what each of the departments involved must contribute to the partnership is essential to ensure that minimal compliance is not being paid to promises that have been made. doors. Large organizations can often be a victim of their own successes because flexibility and adaptability of an operational area or project team become constrained by the modus operandi of the parent organization. The ability to react quickly can often be stifled by the adherence to procedures, which protract the process rather than facilitate an efficient resolution. To qualify, this does not mean that the quality standards, as previously discussed, are either stretched or broken, but rather the actual response time from asking to implementation is being achieved. In an SME environment, without the risk of conflict of interest, there will be a number of core individuals at the disposal of the client who are empowered to make decisions. These individuals can marshal resources across interdepartmental boundaries without the need for complicated forms or apportioning the costs and profits between the different cost centres involved in the project, cutting through the bureaucracy that controls and stifles larger CROs. In the SME environment, the client will have access to all levels of the management structure, from bench to boardroom. Effective communication at the outset will have established both the scope and the parameters of the project, but in the right context it will be understood that there must be an element of slack in these and that, as a project unfolds, there may be circumstances and data that require a quick and effective reaction. In essence, flexibility and adaptability equate to truly working in partnership with the customer, albeit most likely on their terms and conditions! Scientific excellence The concept of the one-stop-shop solution is very attractive to outsourcers of any drug development programme. There is much to be gained from having all the elements situated with a single provider, such as continuity of the work, an understanding of the ‘bigger picture’ and leverage in obtaining the best deal for the package. Global CROs are often the one-stop-shop specialists for all your outsourcing needs. However, while the SME cannot compete on the breadth of its services, it can often capitalize on the depth of services it offers. By bucking the obvious trend to be all things to all men, there is much to be gained from knowing exactly what you do and doing it to the best of your abilities. There are many excellent scientists employed within larger CROs, but they cannot be the masters of all trades. Specialization of the SME in either a therapeutic area or a specific scientific discipline will facilitate a service from the SME that is both targeted and value adding to the client’s end objective. The SME must be able to work on two principle levels. Add value. First, it must add value to the client’s project in a way that the competition cannot easily match. To simply follow the guidance will not be enough; with a wide portfolio of services, compliance with the guidance will easily be within reach of the larger CRO players. Providing specific expert insight or data interpretation requires both experience and a proven track record in an area of science, and the ability to provide something beyond what the protocol or project plan prescribes will undoubtedly add the value that many outsource managers and scientists seek. Guarantee claims. Second, delivery of any claims of excellence must be guaranteed. Failure to meet with customers expectations is a recipe for disaster regardless of the size of the organization. If scientific excellence is the prescribed differentiator, then there must be a tangible mechanism for the client to see, engage with, discuss and understand how the data are to be used. Being able to communicate the science behind the service is what the client wants. Flexibility/adaptability Much is made in the modern day competitive landscape of being a 24/7, 365 service provider, but is it enough to say that our doors are always open? Inevitably, always being open does not equate to being able to meet the needs of whoever walks through the The time to act In summation, size is not necessarily everything. An SME that understands and promotes the basic tenants noted previously, in conjunction with a clear understanding of the customer’s aims and objectives, cannot fail to add value to the partnership. The 24 MAY 2008 PHARMACEUTICAL TECHNOLOGIST

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - May 2008

Pharmaceutical Technologist - May 2008 Contents Industry Highlights Morpheus Market Watch Pharma’s Need for Integrated Safety Is Pharma’s Future Mobile? Facing the CRO Behemoths Q&A

Pharmaceutical Technologist - May 2008

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