Strategies for Preclinical Outsourcing in 2011

When choosing and working with preclinical CROs, what are the key factors that should influence your selection? A recent article, “Smart Moves for 2011,” written by Steve Snyder for the March 2011 issue of Contract Pharma, answers that exact question. The article lists several ways in which sponsors can improve their relationships with, and the quality of work from contract research organizations. Here are some of our favorite tips:

1.       Check the regulatory status, quality history, and accreditations of CROs. There are several questions you may want to ask yourself before selecting a CRO: Will your testing be performed according to GLP regulations? What is the history of the CRO with the FDA? If inspections have resulted in a form 483 issuance what was the reason, and has it been adequately addressed? Depending on your studies, you may even want to speak with the management team regarding quality control. Additionally, you may want to look at the responsiveness of the CRO to any client dissatisfactions that may have occurred in the past.

2.       Provide accurate information when requesting study quotes. CROs, like any company, do their best to estimate business and plan personnel and capacity levels based on expected activity levels. If, as a company, you schedule studies with CROs and then cancel them, it can negatively impact the CROs ability to plan and to handle your business in the future. If you are requesting information for planning purposes only, let the CRO know. Most will still be happy to provide you with costs and information on the chance that they can secure your business at some point in the future.

3.       Be wary of very low prices. This almost goes without saying, but if one price comes in substantially lower than all other bids, there may be something the CRO isn’t telling you. Be sure to ask about past experience with the study type, and compare testing lists from one quote to another to make sure that the lowest cost bid isn’t cutting corners that might negatively impact you later on when it’s time to file an IND or other regulatory submission. Sometimes money saved in the preclinical phase can end up costing you much more later.

4.       Personnel. Have there been significant personnel changes within the CRO? If experienced personnel have moved on, the knowledge necessary to carry out your testing to the highest standards may have left as well. It’s worth performing a little investigation to make sure your project will be completed the right way.

5.       Get your test article to the CRO on time. Study sponsors expect their testing to begin on time, and to finish on time. Yet, some of those same sponsors have been known to delay shipment of samples, which can put an entire study off course from the onset. Many studies, especially complex ones, require a high level of coordination to execute. Key personnel need to be scheduled, space needs to be reserved, and in many cases animals need to be purchased. Late arriving samples can put this entire process in jeopardy. Give your study the best possible chance for success and ship your samples on time.

These are just a few points out of many that the articles lists. The full text is excellent and is definitely recommended reading for anyone looking into new outsources testing services. You can find it here: http://www.contractpharma.com/articles/2011/03/preclinical-outsourcing