Full service vs functional outsourcing in SMEs, with John Shillingford, Director Orsus Medical

Clinical trial outsourcing strategy is a major concern for any company, whether it’s Big Pharma or a small or medium-sized enterprise (SME). With hugely differing budgets and sizes of operation, each sponsor has different requirements and factors affecting its choice of full service or functional outsourcing.

Increasingly, ‘Big Pharma with larger budgets are looking for one-stop-shop turnkey solutions’ according to John Shillingford, a director responsible for clinical evaluations at medical device company Orsus Medical. In contrast, SMEs tend to ‘run clinical development programmes in a very hands-on way, watch costs carefully and minimise reworks, which requires a very integrated approach between the SME and their vendors.’ Shillingford – who is speaking on the topic at T3: Trials, Tech and Transformation – is keen to emphasise that ‘both approaches have their advantages and their dangers’.

‘The full service approach allows the pharma company to move into an oversight role. Everything has the same standard operating procedures and same culture’, but there is a ‘loss of control - perceived or real, and the possibility of poor quality that’s only discovered late in the process’.

Conversely, functional outsourcing allows a greater flexibility to ‘bring in experienced people and expertise the company doesn’t have quickly on short term contracts’. However, this is also presents the biggest challenge; ‘if there is a turnover of these people, the team spends too much time on retraining and monitoring performance and quality’.

It’s clear that there are still problems to overcome with both approaches, but Shillingford sees a number of ways industry can innovate to improve partnerships. The use of technology is at the top of many people’s lists and Shillingford wants to see ‘dashboards to monitor progress and quality’. Alongside that, he recommends the need for ‘full and detailed risk analyses before and during a project's process’ as well as working towards ‘greater integration of sponsor/vendor teams to better focus goals’.

Away from outsourcing models, Shillingford sees the biggest challenge facing clinical trials today as ‘the right patients recruited to the right deadlines with the right level of data quality’. To combat this, he expects greater involvement of patient advocacy groups, as well as the use of social media and ever increasing databases to identify patient populations as among the biggest changes in the next couple of years.