What you bring back from a year on the sponsor's side
A year with MaaT Pharma is ending, and my toolbox has grown a lot. What I take with me, in five points.
The sponsor's chair
Moving from CRO to sponsor side changes everything: writing the oversight plan, choosing the indicators (RBQM, KRIs), preparing and presenting my own metrics at the governance meetings with the CRO. I learnt to steer and measure quality.
Site selection, country by country
Feasibility, submissions, contracting: I broadened my practice of the habits specific to each country, in Europe and beyond (UK, Switzerland, USA, Turkey, Australia).
Building rather than applying
A site selection SOP, a complete SSV toolkit (visit report, attendee log, confirmation and follow-up letters, checklist), a start-up tracking tool, and 10 freelance CRAs trained on the internal processes and coached week after week.
A site audit experienced from the sponsor's side
Attending one from the sponsor's chair is another school of rigour than an audit experienced from the site: you see what auditors expect from a sponsor, not only from an investigator.
Microbiome therapeutics in haemato-oncology
A field that was new to me, and a fascinating one: an innovative therapy that takes each patient's own biological terrain into account and moves towards a personalised product, patients in a critical situation, and a programme that matters.
And one conviction
Oversight is not control. It is a framework set at sponsor level, the global oversight plan, and designed study by study; but its quality comes from coordination across teams and with the CRO: a demanding partnership.
I want to keep growing my skills in both fields, project management and oversight. I am available at short notice for a Clinical Project / Trial Management or Clinical Oversight assignment. Let's talk.
Let's talk