OUTSOURCING
policies and pricing, and significant changes in staffing. In Joelle Herman’s article 5 Major Challenges In CRO Outsourcing And How To Overcome Them, the author states that “sponsor teams are under pressure to deliver results in a fast-paced research environment with resource constraints and operational risks, and the resulting situation can present several operational challenges related to CRO outsourcing”, including: • lack of specificity • lack of transparency • long timelines • generalists versus specialists • dedicated resources Confronted with similar operational challenges, and following a series of one-off CRO relationships, a decision was taken to include a data science CRO as a single data centre, responsible for all clinical trial data from all sources and trials. This strategy gave prospect to the standardization, quality, integrity and security of our clinical data, irrespective of the CRO contracted. A data science CRO in our outsourcing model introduced efficiencies and risk-reduction measures we had previously not experienced, the most prominent being: • Direct access to dedicated data science experts in stable and robust teams with low staff turnover
• Retention of knowledge and expertise acquired in our studies and our therapeutic area
• Development of standard formats, forms and libraries for generation of standardized outputs, reducing study set-up and close- out time, time to submission and costs
• Implementation of risk-based monitoring strategies independent of the clinical CRO for increased transparency of trial status and complimentary to sponsor oversight activities
Since joining Metronomia in 2020, my appreciation for the challenges faced by CROs has grown tremendously. Successful CROs must master the art of managing projects in the dark because no project runs as originally planned and scheduled. Successful CROs need to be equipped with an exceptional troop of contortion artists, bending and stretching themselves to accommodate last-minute changes, with sufficient back-up staff and projects for periods of unforeseen high and low activity, respectively. Finally, a lack of qualified and experienced candidates on the employment market, and the fierce scouting tactics of recruiters luring away staff, are the bitter reality CROs, as well as sponsors, encounter on a day-to-day basis. My introduction of a data science CRO model of clinical trial outsourcing, and over eight years of successful implementation at my former company – together with my decision to join the very same data science CRO partner as managing director – are testament to the viability of the model for sponsors facing outsourcing challenges now and in the future.
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