Strategies for managing an outsourcing partner

Robust oversight linked to increased efficiency and better communication with outsourcing partners. 

However, engaging an outsourcing partner such as a CRO or CDMO comes with its risks. According to Stephanie Gaulding, Managing Director at Pharmatech Associates, the more hands-off approach a sponsor takes, the higher the risk becomes.  

Gaulding led a session on strategies for managing outsourcing partners at CPHI North America this week and emphasised the importance of creating a robust oversight framework.  

‘You need to have processes in place to control quality and oversee your outsource activities,’ she told conference attendees.   

‘Without these processes you can run the risk of things going awry - not having adequate oversight, not making sure that products are made in accordance with the associated regulations.’ 

Gaulding recommended defining activities that can be delegated early in the process, and clearly outlining these in contractual documents.  

She added that the level of oversight a sponsor retains is a crucial consideration – too little can lead to delays and miscommunication, while micromanagement can result in inefficiencies.  

She said: ‘What we ultimately want to do is stay in that middle range, where we have tailored oversight that is tweaked and adjusted per the conditions that you’re dealing with. That’s going to get you to optimal efficiency, that’s going to get to robust communication.’ 

Gaulding encouraged sponsors to create detailed oversight plans, which includes everything about the scope and nature of the engagement with the outsourcing partner. She noted that gaining familiarity with an outsourcing partner’s internal processes and systems can pay dividends, so that requirements imposed on them are manageable and more likely to result in success.  

‘I’d encourage everybody to understand your partner’s processes really well, go into it with an open mind and only make adjustments where you absolutely think there needs to be an adjustment,’ she said. ‘Because you’re going to cause them to trip over themselves trying to remember all these additional requirements.’ 

Gaulding also advised assessing a partner’s risk points, mitigating these where possible, and enacting a change management plan.