CRO/Vendor Oversight
Make the most out of your partnerships
Outsourcing is great. It gives you flexibility while it brings the benefit of shared expertise and experience. On the other hand, outsourcing without proper alignment of expectations, controls and oversight may turn into data quality issues, delays, extra costs and overall frustration.
At CLINERGY, we deeply understand what makes successful partnerships and what the potential watch-outs are. We can help you navigate these.
Having an independent party fully focused on different aspects of CRO/Vendor oversight not only allows you to invest your time and energy on strategic decisions that really matter but it also increases your ROI by reducing quality issues and delays.
A "not so pretty" picture
Although the clinical outsourcing market remains on an upside trend, an increasing number of sponsors go through frustrating outsourcing experiences due to limitations of the traditional outsourcing business model.
High staff turnover
The clinical research outsourcing market is known for its high turnover with an average 25% CRA turnover rate (getting up to 70% in some countries) and a 21% PM turnover rate, according to a 2017 survey.
Ever increasing workload
In order to maximize operational earnings, it is not uncommon to have Project Managers within large clinical vendors working for 15+ clients simultaneously on completely different areas and study types.
Stretched too thin
In order to provide competitive bids, some vendors provide unrealistic assumptions around key operational aspects, ultimately leading to delays and quality issues, which turn into additional costs.
Such limitations pose great risk to business continuity throughout the life cycle of studies and create most of the frustrations experienced by sponsors such as lack of focus and responsiveness, poor communication, quality issues that could have been avoided, among others.
While we can’t change the sad reality presented above, we can add real value by utilising our world-class experience and expertise to plan, track and adjust strong oversight systems, tailored to each client-CRO relationship, so that such inherent risks and threats are mitigated for.
Our highly experienced team understands the cultural diversities and distinct clinical approaches that come into play when working on international clinical trials.
Our oversight services include:
Sponsors are ultimately responsible for the integrity of the data generated by their third-party vendors. CLINERGY’s assessment eliminates the inherent bias that may exist in a long-term relationship between a sponsor and its CRO through objective assessment of CRO’s activities and standards. Our assessment provides you with a clear picture on whether you are getting value for the money you are investing.
Do you need highly qualified professionals to oversee your CRO’s activities on a continued basis? CLINERGY offers world-class oversight capabilities gained from our experience overseeing clinical studies in different therapeutic areas across the globe. We will oversee metrics, risk management plans, monitoring activities and all critical operational aspects of your projects to ensure you are getting the best possible return on your investment.
Our oversight visits allow us to assess the performance of CRAs with a critical eye towards continuous improvement and relationship with site staff, reducing nonconformance-related delays and costs.
Vendor Oversight Plans (VOPs) are essential in ensuring compliance and optimal deliverables when it comes down to any working relationship between two parties. Very frequently, such plans are written in a “check box exercise” manner, which leads people to not use it properly. At CLINERGY, we develop VOPs that are user-friendly, metric-driven and present key information in a ready-to-use format. We make sure key elements established within the VOP are extended to other tools used in the study, so that such elements are ever visible and present on the team’s routine.
Our in depth-assessment of the sponsor-CRO relationship and of the CRO’s performance allows us to propose, develop and implement value adding tools and working instructions in order to close gaps and reduce study related inefficiencies.
Whether you need an one-off assessment or continued vendor oversight support throughout the life cycle of your studies, we are here to help you.
