CMO
What to Look for in Selecting a CRO/CMO and How to Ensure the Right Choice: A Quality Assurance Perspective
Amer Alghabban
Managing Director, GxP Compliance and Training Partners (GCTP), Basel, Switzerland
Former Global Head, Director QA Merck Serono, Global Head GxP QA Arpida
Submitted: 02/17/2015 Accepted for Publication: 02/24/2015
Alghabban A. What to look for in selecting a CRO/CMO and how to ensure the right choice: a quality assurance perspective. Pharm Outsourcing. 2015;16(2):14-21.
Outsourcing used to be done for mostly “non-critical products/services,” but the last 20 years have seen a reversal in this trend. More and more companies are outsourcing key critical Good X Practices (GxP)- regulated clinical processes and products manufacturing. To improve efficiency and increase productivity, reliance on Contract Manufacturing Organizations (CMOs)1 continues to increase.
and Clinical Research Organizations (CROs)2
When selecting service providers, according to a recent survey,3 sponsoring pharma companies stated that they focus on the following criteria (listed in order of importance). Respondents described the following as “very important”: Confidentiality (81%); Quality (81%); Consistency of performance (79%); cGMP compliance (75%); Regulatory inspection history (69%); timeliness (60%); contract firm’s financial stability (56%); and project cost (54%).3
Pharmaceutical company
sponsors are outsourcing more functions so that they can focus on their core strengths.4
Similarly, a third of clinical trials conducted by pharmaceutical firms are outsourced to vendors,2
increase of outsourcing to CROs.5
However, the selection of clinical CROs seems more focused on matching chemistry, ie, that they can work with the CRO (63%); followed by the perception of dedication (62%); experience in the same indication (61%); and CRO overall experience in the study’s therapeutic area, but hardly any weight is given to Good Clinical Practice or Good Pharmacovigilance Practice compliance.5
The way a pharmaceutical company contracts CROs/CMOs has a critical and direct impact on a company’s realization of its goals. Many
with 70% of pharma companies expecting an
collaborations have ended with catastrophic outcomes with shock- waves impacting all stakeholders, including the patients. In another survey,4
nearly half (45.6%) of responding pharma companies stated
that they had quality problems resulting from vendors, poor product quality, poor service quality, inexperience with regulatory requirements, and 49.1% of vendors made promises they could not keep.3,4
So where does it go wrong? Was the final decision not based on the most important factor—Good Manufacturing Practice (GMP) Compliance?
Identification and Selection of CROs/ CMOs: A Science or Art?
The Challenges
Outsourcing can present a unique type of challenge to any organization; it is both a challenge in its own right as well as a solution to another business challenge.3
The challenges are multi-faceted:
• As the highest risk is assumed by the company, it is, therefore, critical for the client company to implement a wide array of risk- mitigation tactics6
• The CRO/CMO business model is not designed to absorb high levels of risk
• Quality is variable and influenced by many factors • Cost savings can be less than expected in the end • Cost reduction initiatives can have an impact on performance
Pharmaceutical Outsourcing | 14 | March/April 2015
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