“We found that [sponsor] companies that document their quality expectations very well… at the beginning of a clinical trial, in fact, have much better results. “I was very surprised by the different responses,” added Leuchten, explaining that only half of the sponsors are satisfied with the overall quality of the suppliers, while the CROs surveyed feel they are doing a good job and providing quality services. The results of the survey were both interesting and disturbing and showed an important opportunity to engage stakeholder organizations to strengthen the links between expectations of quality and refinement for the proper implementation of these expectations. Data from the 2011 survey show significant and different differences between the perception of quality by sponsors and CROs obtained through the implementation of outsourced clinical programs. The differences in perception are remarkable for the “very satisfied” and the “dissatisfied in general”, the sponsors being generally less satisfied. CREATING A WIN-WIN SITUATION The participation of the management of each company and the clinical and quality teams involved was crucial to the success of the negotiations and the implementation of quality agreements and metrics. This was important because it determined what each party considered important to perform a quality test. The collaborative approach to the development of a quality agreement creates a sense of ownership of the project by all participants, with the common goal of carrying out a quality study. This will ensure a “win-win” situation in which both parties will be required to discharge their responsibilities and focus on unilateral errors made by the supplier if they do not meet sponsorship standards. Following the implementation of a quality agreement, a sponsor has conducted a study that meets its expectations and the supplier has gained the trust of the sponsor, which will hopefully lead to more fruitful future collaborations. The quality requirements for conducting clinical trials are absolute; few of them would debate in the pharmaceutical, biotech and CRO sectors. However, longitudinal data collected by Avoca Group point out that there are still definitions of quality, orientation to required quality levels and success in meeting these expectations. Business models for the design and implementation of clinical trials require that several stakeholder organizations (e.g.
B pharma/biotech, CROs, co-development partners and regulatory authorities) align themselves with mutually agreed quality expectations and successfully implement them. Each member organization has access to a comprehensive and proprietary knowledge centre with more than 400 leading procedures, guidelines, tools, templates and process documents, as well as AQC research and archived webinars. The willingness to inspect is a recurring challenge. How are you prepared? Are you ready to hand over your eTMF login data to an accountant? The concept of risk management has been discussed in clinical research for several years. With the introduction of ICH E6 (R2), risk-based quality management has become mandatory for clinical trials. Risk assessment, risk-proportionate monitoring and quality management approaches must be documented, justified and validated through measures. This documentation must be monitored and maintained, as auditors and inspectors, who primarily base their assessment on the ICH-GCP guidelines, will take these risk and quality management approaches into account and determine compliance with documented procedures and processes commensurate with the risks. Disproportionate risk approaches even address the content of the TMF/eTMF and require that certain process documents become essential documents. One membership benefit includes unlimited enterprise-wide access to the AQC Knowledge Centre, an online portal with more than 400 leading firms, guidelines, tools and models to improve efficiency, improve quality and reduce risk in clinical trials.