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We found that our discussions on quality agreements were an insightful process that created a dialogue with our suppliers and CROs and established more meaningful relationships between the parties. For example, a measure of our quality agreement required reporting on all critical audit results of regulators or proponents in a contracted region with respect to a contracted service. The quality assurance representative of the respective clinical service provider stated that it could not accept this measure because of its obligation to maintain the confidentiality of its clients. This led to a discussion on the root of the measure, which should provide assurance that a rigorous process will be followed when assessing the potential impact of critical audit results on other programs in the region or other programs that use the same service. We explained to the QA representative what we expected from a robust process, and the clinical service provider assured us that it had SOPs and work practices (WPs) that governed the assessment of potential impacts on other programs. Although the essence of what we described was detailed in their SOPs and WPs, the Quality Assurance Representative agreed that their process could be improved to meet our expectations. This led to a revision of their SOPs and WPs. Another example of how our quality agreement negotiations facilitated collaboration was our discussion with a CRO about the requirement to hold at least one quarterly risk management meeting to identify risks and develop mitigation plans. During this discussion, we were able to present to the CRO the use of the Failure Mode and Impact Analysis Tool (FMEA) in risk management for our studies. Both sides committed to establishing a risk management process in the quality agreement in which specific details would be discussed at future meetings. CONCLUSION OF A QUALITY AGREEMENT Quality agreements are well established in other industries such as manufacturing and finance; However, such agreements only apply to the conduct of clinical trials. A number of corporate sponsors participate in various consortia such as the Avoca Quality Consortium, which has developed a standard model for quality agreements with metrics. Examples of these measures, or Key Quality Indicators (KPIs), include the turnover rate of key personnel, the requirement to hold quarterly risk management meetings, the number of Corrective and Preventive Actions (CAPAs) implemented, and the CAPAs resolved within the timelines set out in CAPA.

Two common objections raised by suppliers during negotiations on measures included how proponents felt that the resources required to collect and manage the measures could deter the supplier`s actual performance in its study-related tasks and how certain measures could be influenced by forces beyond the supplier`s control. First of all, when negotiating the measures, we have endeavoured to continuously evaluate the measures that the clinical service provider generally collects and, therefore, to follow the additional measures only when we deem it absolutely necessary. When considering measures that may be influenced by forces beyond the direct control of a supplier, we have taken care to allow “exceptions,” which included “force majeure,” natural disasters, and unforeseen changes by regulators. Apart from these common objections, both parties acknowledged that the purpose of the quality agreement measures is to assess whether there is a trend in all our studies that can be learned and applied from ongoing and new studies in order to avoid a repetition of frequent complaints from promoters/suppliers. The collaborative approach of creating a quality agreement creates a sense of ownership of the project by all parties involved, with the common goal of conducting a quality study. This ensures a “win-win” situation in which both parties commit to fulfilling their responsibilities without blame and without concentrating one-way errors on the supplier because it does not meet the promoter`s standards. As a result of implementing a quality agreement, a sponsor has a study that meets their expectations, and the supplier has earned the sponsor`s trust, which hopefully leads to more successful future collaborations. According to data collected through a 2011 Avoca sector survey of sponsoring organizations, only about 65% of respondents had quality agreements with their CROs. However, in the same survey, 94% of respondents who used a quality agreement were satisfied with the performance of their CRO, while only 59% of respondents who did not use a quality agreement were satisfied with the performance of their CRO. This supports the idea that entering into a quality agreement is essential to establishing a strong relationship between the sponsor and the CRO. As clinical research continues the trend of outsourcing more clinical trial activities to clinical service providers such as CROs or other providers, it is essential that sponsors ensure that the activities they outsource are conducted in accordance with the sponsor`s quality expectations.

Due to short development times, often after a rigorous selection process, the clinical service provider immediately begins working on the project without both parties discussing their quality expectations. Discuss We realized that when we introduced the quality agreement and related measures into our company, we first needed to evaluate as a team how it fits into our overall governance model for clinical service providers. This led to discussions about our company`s quality expectations, followed by important negotiations on the proposed measures. In short, our company`s governance model for clinical service providers is based on a Master Service Agreement (SFM), which describes the scope of work of each specific study in an addendum. The quality agreement is executed as a separate contract that uses the MSA, and it describes the quality expectations with associated measures for all projects that are outsourced to the respective clinical service provider. The measures contained in the quality agreement represent elements that have been agreed as quality indicators and have been aggregated in all outsourced studies. Each MSA addendum that describes each individual study has a service level agreement (SLA) that includes the agreed expected level of service, penalty, and bonus language for that particular study. The Quality Agreement provides a means and structure to establish the parties` expectations, identify deviations from those expectations, and establish an escalation process to address/mitigate those deviations. The key to successfully negotiating the quality agreement is a clear communication of expectations between the parties and the emphasis that each party has a sense of ownership of the study through a jointly agreed language. CREATING A WIN-WIN SITUATION Decisive for the success of the negotiations and the implementation of the quality agreement and metrics was the involvement of the management of each company and its respective clinical and quality teams. This was important because it identified what each party considered important to conduct a quality study. By Jonathan Lee, Vice President of Development Operations and Mary Chow, Director of Contract Management, Cerexa..

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