Resource optimization: Uncharted territory in vendor oversight
In a recent Comprehend webinar, Laurie Halloran presented some stimulating ideas on how to address an underserved issue in optimizing resources between Sponsors and CROs. While there has been much talk about finding metrics that both teams can share, and how to address risk issues, it has come up repeatedly that a lot of the stress felt between these two groups comes from misaligned goals, roles, and expectations.
According to Laurie, there are five Top Best Practices that sponsors can address to optimize their Vendor relationships:
- Match outsourcing strategy to business strategy
- Plan & select fir-for-purpose vendors
- Set up a collaborative relationship with clear expectations
- Set up and manage through use of objective measures, including financial ones
- Shape performance through management, not redoing work
Within each of these areas, she explained not just the theory behind the best practices, but also the operational approach. When considering an outsourced relationship, she suggested that Sponsors may want to define their core competencies in advance of sourcing help and make a considered trade-off between what could be managed in-house (i.e., with technology) versus what could be outsourced.
Another point of consideration is spending the appropriate amount of time to evaluate the vendors. Rather than distributing RFPs and making decisions on what comes back, Laurie advocates the analogy of a committed relationship – where areas such as setting expectations, defining critical success factors, and culture fit come into play. As in all vendor selections, the work to determine risk versus benefit, and what sort of ROI will come out of the relationship, is always good advice.
One crucial element of vendor relationships is the concept of “we” rather than “us vs. them.” Internal and external teams need to not only agree on the same goals but need to work collaboratively. This means understanding where the other team is coming from and putting yourself in their shoes. Laurie defined the process these teams must agree on to manage milestones, deliverables, and interactions. Another key takeaway was her advice to not work IN the project, but more importantly, work ON the project. This helps avoid a huge time-sink for the Sponsor – an expensive mistake to make. It makes sense that when a sponsor has to do rework, it’s an indication that the deliverables and milestones were not clearly defined with the vendor.
In an audience poll during the webinar, a majority of sponsors indicated that their top concern was integrating multiple data sources. This is a key piece of information – in recent Benchmark Surveys, both sponsors and CROs ranked the timeliness and difficulty in achieving successful data integration as a major issue for them.
Following Laurie’s advice, Comprehend followed up with a case study on how a midmarket Sponsor put these strategies to work. The Sponsor was challenged with a growing number of studies plus the work to add another CRO to its existing two, and yet it needed to accomplish all of this with no additional staff.
They applied Clinical Intelligence applications to jointly select important metrics and prepare a Quality Agreement Plan with defined roles and escalation paths. The applications helped clinical and medical teams reduce time and effort in accessing the data and reports they needed at the time they needed it. Safety risk signals were automatically sent to both internal and external teams with a collaborative method of jointly sharing the work on issues.
The result was a reduction in hundreds of hours of work in both clinical operations and medical review teams, along with staying within safety risk thresholds. Proof that optimizing resources through the use of automation does work!
Click here to listen to the webinar.
Comprehend offers a suite of Clinical Intelligence applications that enables ClinOps Execs, Data Managers and Medical Monitors to significantly improve the speed, safety, and quality of a portfolio of clinical trials. Across studies, sites, systems and CROs, Comprehend’s Clinical Intelligence Suite is particularly effective for centralized monitoring, risk monitoring, CRO oversight and collaboration, data review and medical monitoring initiatives. With powerful capabilities to intelligently unify, monitor, and analyze clinical data across CROs, studies, and systems, Comprehend gives life sciences companies the ability to address the most difficult and complex FDA guidelines for quality, risk and oversight. Comprehend: the speed to quality results.