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CONTRACT SOURCING LIFESCIENCELEADER.COM JANUARY 2015 40 outsourcing ith clinical research con- tinuing the trend of out- sourcing more clinical trial activities to clinical service providers such as CROs or other vendors, it has become critical for sponsors to ensure that the activities they have outsourced are per- formed in accordance with the sponsor's quality expectations. Because of short- ened development timelines, often after a rigorous selection process, the clinical service provider immediately starts work on the project without the benefit of both parties discussing their expectations of quality. Based on the data collected in a 2011 Avoca Industry Survey of sponsor organizations, only about 65 percent of respondents had written quality agreements with their CROs. However, in the same survey, 94 percent of the respondents that used a quality agreement were satisfied with their CRO's performance, while only 59 percent of the respondents that did not use a quality agreement were satisfied with their CRO's performance. This supports the idea that establishing a quality agree- ment is crucial in building a strong relationship between sponsor and CRO. ESTABLISHING A QUALITY AGREEMENT Quality agreements are well-established in other industries such as manufacturing and finance; however, such agreements are just starting to be applied to the conduct of clinical studies. A number of sponsor companies are participating in various consortiums such as the Avoca Quality Consortium, which developed a standard quality agreement template with metrics. Some examples of these met- rics, or Key Quality Indicators (KQIs), are turnover rate for key personnel, commit- ments to holding quarterly risk manage- ment meetings, number of corrective and preventive actions (CAPAs) implemented, and CAPAs resolved within the time frame specified in the CAPA. The quality agreement provides an avenue and structure to set the expecta- tions of the parties, identify any devia- tions from these expectations, and specify an escalation process to address/mitigate these deviations. The key to successfully negotiating the quality agreement is clear communication of expectations between the parties and the emphasis on each party having a sense of ownership over the study through mutually created, agreed- upon language. HAVING THE CONVERSATION We found that when introducing the qual- ity agreement and associated metrics to our company, we first needed to evaluate as a team how it fit into our overall clinical service provider governance model. This led to discussions of our company's expectation of quality, which was followed by significant negotiations regarding the proposed metrics. Briefly, our company's clinical service provider governance model is centered upon a mas- ter service agreement (MSA) with each specific study's scope of work described in an addendum. The quality agreement is executed as a separate contract which leverages the MSA, and it details expecta- tions of quality with associated metrics for all projects outsourced to the specific clinical service provider. The metrics contained within the quality agreement represent items agreed-upon as indica- tors of quality aggregated across all of the outsourced studies. Each MSA addendum that describes each individual study has a service level agreement (SLA) that contains agreed-upon expected service level, penalty, and bonus language for that particular study. We found our quality agreement discus- sions to be an enlightening process, which created dialogue with our vendors and CROs, building more meaningful relation- ships among the parties. For example, one metric in our quality agreement required the reporting of all critical audit findings from regulatory authorities or sponsors within a contracted region regarding a contracted service. The specific clinical service provider's QA representative stat- ed that they were unable to agree to this metric due to their obligation to maintain confidentiality of their clients. This led to a discussion about the root of the metric, which was to provide assuredness that a robust process is followed when assess- ing the potential impact of critical audit findings upon other programs within the region or other programs which use the same service. We explained to the QA rep what we would expect of a robust process, and the clinical service provider reassured us that they had SOPs and work practices (WPs) which governed the assessment of potential impact upon other programs. However, while the essence of what we described was detailed within their SOPs & WPs, the QA representative agreed that their process could be enhanced to meet our expectations. This led to a revision of their SOPs and WPs. J O N A T H A N L E E A N D M A R Y C H O W Quality Agreements In Clinical Development: A Road Map Toward A Successful Partnership By J. Lee and M. Chow QUALITY AGREEMENTS IN CLINICAL DEVELOPMENT: A ROAD MAP TOWARD A SUCCESSFUL PARTNERSHIP W