OUTSOURCING D
ata science contract research organizations (CROs) are providers of clinical research services focused
on domain expertise, programming skills, and knowledge of mathematics and statistics, to extract meaningful insights from clinical data. In 2012, I introduced a clinical research outsourcing model to our company, which included a data science CRO as a constant partner. Eight years later, I decided to join this data science CRO partner as managing director. This article outlines the reasons for incorporating a data science CRO into a clinical trials outsourcing model and my transition from sponsor to CRO.
In the summer of 2011, after my second maternity leave, I returned to work at a mid- sized, European pharmaceutical company to take on the leadership of clinical operations. At the time, the clinical operations team was miniscule, with 1.6 FTE, all in project management (PM). With a large portfolio of products to be clinically investigated over the next seven years – and a gap in PM resource, data management and biostatistical expertise – it was time to think strategically. A cry for help to the Department of Statistics at Ludwig-Maximilian University led us to Metronomia Clinical Research, a data science CRO in Germany. Rewind to September 2005, when I joined the company to complete two ongoing phase-2 studies managed by two different full-service CROs and to select a further CRO to manage the largest international phase-3 allergy study of the time. In my 15 years in clinical trial management, and from 2015 to 2020 as global head of clinical operations, I observed a general pattern of cooperation between our mid-sized company to describe my experience. Tuckman believed that these phases are necessary and inevitable in order for a team to grow, face up to challenges, tackle problems, find solutions, plan work, and deliver results. Group development in sponsor- CRO teams generally occurs according to Tuckman’s model, but with the added challenge presented by differences between the companies in terms of interests, locations, regional and company cultures, pain-points and other aspects. The forming–storming–norming stages are
44 | H1 Virtual Events: Review and Summary Handbook
known collectively as the transforming phase and are followed by performing and reforming phases, in the John Fairhurst TPR model. In new collaborations with CROs, parallels can be drawn between the transforming phase and the honeymoon phase seen in developing personal relationships. Simply put, CROs are eager to please new customers, and to secure these for future projects, and clinical research sponsors are enamoured by the features, scope and promises of the new partner. However, in the performing stage, CROs may find themselves struggling to deliver on promises and meeting sponsor expectations, inevitably leading some customers to fall into a state of disillusionment and potentially to switch CRO partners, foregoing the reforming phase completely. One goal of the reforming phase is to allow the group to look back on the collective experience together, capture best practices or lessons learned for future use, and prepare the group for a further round of transformation, saying goodbye to departing members and optimally integrating new members. Hence, a short or one-off collaboration between sponsor and CRO can often result in a loss of return on investment (ROI). From this perspective, our ROI from
collaborations with CROs was decisively low. It was uncommon for a CRO relationship to extend beyond two trials for outsourced clinical services (e.g., trial feasibility, country and site selection, regulatory submissions, clinical monitoring, and site and vendor management). Perhaps we were “unlucky” to have partnered with CROs that underwent insolvency, mergers and acquisitions, or assimilation into the acquiring companies, which led to unexpected and undesirable changes in teams, services,
“Successful CROs need to be equipped with an exceptional troop of contortion artists, bending themselves to accommodate changes, with sufficient back-up staff and projects for periods of high and low activity”
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58
