Pharmaceutical Technology Europe - September 2010 - (Page 15)

Making a CRO project run smoothly When embarking on a new outsourcing project, there are a few initial steps that must be taken to ensure a project runs smoothly from the start. Firstly, the scope of the project must be discussed in great detail with the sponsor so Sponsors tend to be a little bit more hands-on at the beginning of a project until a few weeks go by and a certain level of comfort is established… that expectations are aligned. For example, if the CRO is requested to use the sponsor’s SOPs then these should be analysed to see if they will impact the time required to complete the project. All deliverables and assumptions must also be clearly documented along with the risks and their corresponding contingency/ mitigation plans. Sponsors tend to be a little bit more hands-on at the beginning of a project until a few weeks go by and a certain level of comfort is established that the project is going to plan. The first deliverables will be carefully reviewed to verify that the required level of quality is in place. Very often the contingency plans agreed up front can be put to the test early in the project if the sponsor delays or introduces a last minute change to the protocol. If the CRO is to work to the sponsor’s SOPs or on the sponsor’s own systems then there can be a learning curve, which is best minimised through a formal training programme. a selection of CVs to review in order to play a part in selecting the team for their project. Integration of CRO employees with sponsor staff is usually quite a speedy process. Arranging a short induction programme in advance, however, can make the CRO employee feel a lot more comfortable right from the outset. PTE Chris Hamilton The right team Selecting the right team is critical to the success of a project. A CRO should have its employees well catalogued in terms of their competency, years of experience and therapeutic experience. There is usually enough time between contract negotiation and project start to “pre-book” the most appropriate resource for the project. This is key to the successful running of the project and leads to a high level of customer satisfaction if the sponsor can be guided by the prior experience of the project team. Where there is a large pool of resources available, the sponsor should take the initiative and ask for Based on a contribution by Chris Hamilton, Director of Business Development at Quanticate. To read the full version of this article, go to www.pharmtech.com/hamilton www.quanticate.com 1 CONTENTS 9 THE RIGHT ASIAN PARTNER 3 SLOW CLIMB BACK 10 INDIAN PERSPECTIVE 6 FINANCIAL CRISIS 14 SUCCESSFUL RELATIONSHIPS 7 HOW TO COMPETE 16 READ MORE… http://www.pharmtech.com/hamilton http://www.quanticate.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - September 2010

Parmaceutical Technology Europe: September 2010
Contents
Pharmaceutical Technology Europe Poll
Slow Climb Back
The effect of teh Financial Crisis on Outsourcing
How a CMO Can Compete In An Increasingly Competitive Market
How Responsible Should the Sponsor Be For The Outsourcing Provider's Success?
How to Identify the Right Partner in Asia-Pacific
The Indian Perspective
The Challenges of Outsourcing Early Development
The Benefits of Outsourcing Highly Potent API Manufacture
Managing an Outsourced Biologics Project
Successfully Managing CMO - Client Relationships
Making a CRO Project Run Smoothly

Pharmaceutical Technology Europe - September 2010