Thoughts/Warnings about choosing mid/smaller CROs

Discussion in 'CROs - General Discussion' started by Anonymous, Sep 19, 2011 at 12:53 PM.

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  1. Anonymous

    Anonymous Guest

    When choosing a small local regional CRO here are a few pointers to be wary of based on my prior bad experience(s):


    1) if the CEO is a finance person with little or no healthcare contract services experience in his/her cv; especially if he has made small market entries into LSE, IEX, NASDAQ... run the other way...he/she just wants to show the shareholders he can craft a 20-30% profit margin out of smoke and mirror sales to bio/pharma using a ensemble of cast and crew he contracts for your project. Not to forget that he/she tags on 10% of the amount of capital they raise via some government grant scheme for start-ups.

    2) if the company claims to have "relationships" that enable them to provide global services or minimum "international" scope services; run the other way...because this means I have registered a enterprise in 2-3,4,5 countries with rented office addresses in the middle of nowhere, with one contract CRA residing there, and I solely use body leasing companies to fool you into believing that I have such capabilities.

    3) if they claim to provide "faster cycle times for sponsors" or to "accelerate the delivery of drugs to the market worldwide"; run the other way...these people play on being nimble because John or Jane in the back office was at one time a PM for a blue chip pharma clinical team -developing the last blockbuster the world saw in the 1990's and happened to work with regulatory officials on a first name basis....or they did not make the cut when working for one of the top 5 global CROs, (ex. burnout, fatigue, etc...) in which case they are sub-par for plenty of reasons.

    4) if the company claims to be "an extension of your team"; run the other way...because this means you are so bad at what you do that this actually makes sense....

    5) if they claim "strict adherence to SOPs, GCPs and regional guidelines"; well, send in a real auditor with boots on the ground and see if this can be supported with hard facts. Otherwise you can be fooled by a piece of paper that says "no actionable findings..." or better yet; like hiring a new employee –do a thorough background check, lookup past customers or employees. They typically have "former colleagues" give references which later is interpreted as a happy customer....

    6) if your services provider claims "to be more cost effective" well duh, we all know what the top tier CROs are charging and its pretty steep but when you strip away all the other stuff you are still getting value for money from the big boys. So the crafty small CRO -CFO takes his trusted calculator and comes in about 40% cheaper and plays on cost. This is still a good chunk of change for a small company so you (sponsor) love the savings on the surface. Tell your procurement guys that you value your career and will not compromise integrity of data/patients for saving a few bucks.

    7) if your services provider has an EDC system which they claim performs just "like"; well let's say Medid@t@ (not to plug anyone); run the other way. Its not validated, open DB and they can mess with fields, dates and time stamps. I have seen cases where patients were randomized, then flagged as ineligible, then surprise another patient randomized to the same number like it never happened. Vanished without a trace...

    From time to time I will chime in and share some bad experiences in order to expose the tricks of the trade. In the end there are several reasons why you outsource, but the space is overcome with imposters and people who put profits before patient safety or the integrity of the data. A few bad apples really.

    PS one last point, I have used linkedin to gather intelligence about employee turnover, actual global presence, or better yet I have reached out to past employees to get a feel for the sort of provider they really are. Happy to report that so far so good.
     

  2. Anonymous

    Anonymous Guest

    Previous message sponsored by Covance and Charles River...
    Thank you
    Captain Obvious