Case study 1
Built a virtual, multi-disciplinary, international team of functional experts to plan and execute a development program for a novel medical device with an ancillary medicinal substance. Steered the program from laboratory bench to regulatory approvals, including design and delivery of pivotal trial and selection, management, oversight and governance of CROs and CMOs. Built a robust compliance and governance model for third party service providers.
Case study 2
Resolved protracted dispute between sponsor and CRO on a phase II clinical trial study in erectile dysfunction: Created dialogue, established shared commitment and vision, resolved conflict of interest, resolved performance issues, re-established a high performance collaboration, steered project delivery on time and to budget.
Case study 3
Directed the delivery of a complex phase II study in childhood asthma for a CRO working on behalf of a global pharmaceutical company. This was an innovative, outcomes-based, risk-sharing contract model and presented a raft of novel challenges both for the CRO and the sponsor. Built and directed a high performing team to deliver this high value, high profile project ahead of time, on budget and to demanding quality standards.
Case study 4
Devised and delivered discrete, robust quality platforms for development of pharmaceuticals and medical devices within a virtual start-up company. Engaged the board and the staff to establish a culture of high quality. Introduced parallel suites of SOPs and independent QA and audit functions with implementation of staff training throughout the organisation. Successful MHRA and MDA inspections with no critical or major findings