By: Natalia Vlcek – Pharmacovigilance Manager and EU QPPV – Arriello Group
For many clinical research organizations (CROs), offering full-service outsourcing, safety is too often an add-on. The risk of this approach is the safety team is not sufficiently knowledgeable to ensure full compliance or to support clinical trials efficiently. Global CROs offer a large network of local partners – and that may be initially reassuring to multinational pharma companies. But there’s often a disconnect when it comes to using that network effectively for clinical safety.
So often, the CRO’s global partner network knows everything about how to get the trial registered and how to run the trial, but they are less experienced with safety. They may suggest a less than optimum approach to safety or, through inexperience, request time to consult with local National Competent Authorities (NCAs) on a safety question. This introduces inefficiencies and potential non-compliance because the trial is running like a train that cannot be stopped while the safety services are still trying to catch up. Delays and inefficiencies have led to pharma businesses having to double or even triple their clinical safety budget.
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Practical Steps
There are several practical steps that can support pharma businesses looking to put safety front and center of clinical research outsourcing strategy.
It is important to avoid a one-size-fits-all approach. Each product has a specific safety and efficacy profile. Pharma businesses vary in size and focus, from small biotech to orphan oncology to generic bioequivalence, all requiring specific expertise on varying budgets.
Any outsourcing arrangement must take account of the protocol planned for the study, the characteristics of the product – and the business type and size. If a small biotech company is the sponsor of a study, it may need more consultancy and proactive advice on how to approach certain areas, rather than a traditional execute-only partnership.
If companies don't get this right, it can lead to inflated costs. For example, a small biotech company working with a large company that offers safety as an adjunct may find themselves paying for systems and processes that are over and above what they need. This can lead to a lot of unpleasant budget surprises for the client, arising from additional meetings and customization. When choosing a supplier for outsourced services, this type of business would need to focus on a requirement for consultancy and partnership.
Communication Issues Cost Money
Another key step to putting safety front and center of clinical research outsourcing strategy is to prioritize effective communication. An efficient exchange of information is crucial to nip potential issues in the bud and to stay ahead of any issues that might develop into a safety risk to patients or a budget drain on the study. Communication issues cost money and may even impact the quality of the safety part of the trial.
For many vendors offering outsourcing services, a partnership approach to safety demands a cultural change that they have yet to make. So, when assessing reference sites, look for evidence of very frequent communication – multiple meetings and not just with the technical team and the study execution team, but also between the project manager and the contact person on the sponsor side, to discuss everything that’s going on from an oversight perspective. And check that communications highlight the pain points and provide clear actions, rather than just comprising masses of unexpurgated data.
Sub-Optimal Use of Local Networks
Clinical safety vendors range from small companies offering services in a single region to the big CROs offering clinical safety as an add-on service. The bigger the company, the bigger the global footprint. Yet the ‘big boys’ often fail to make optimal use of their local network, to ensure the study sponsors have the correct and most up-to-date information for full compliance, whilst not losing out on efficiency.
The reasons for sub-optimal use of local networks range from slow knowledge transfer processes, long reporting lines and circuitous reporting routes and no drive to keep costs down. Smaller and mid-sized companies often have more direct communication channels within their global network and will understand the importance of keeping sponsor costs low.
It is important to ask potential outsourcing partners questions about the governance of the local network. Ask difficult questions. How do you make sure that you will get the information that we need from the vendors and in a format that is usable? How do you keep oversight of the local subcontractors and vendors? Do you audit them? Do you speak to them on a regular basis? And how do they optimize those networks?
Consistency Drives Efficiency
Achieving consistency in safety information across studies can go a long way to driving efficiency – and safety. Ensuring data consistency in an outsourced arrangement is a challenge. Sometimes sponsors choose different vendors for each study, due to regional coverage or a specific expertise in a disease area. The downside of this approach is that safety information is scattered across multiple systems.
This makes it difficult to maintain an oversight of the safety database. Processes are less efficient as various teams all need training on different systems. At the end of the process, multiple data migrations will be needed. There’s a clear benefit in having all the data in one place, facilitating a holistic view. At the same time, this approach provides an oversight of vendors and helps maintain good communication with them.
Ensure Safety is a Central Requirement When Outsourcing
Many CROs offer safety as an add-on service. The danger inherent in taking this approach is that the safety team is often not specialized. To avoid the possibility of multi-tasking clinical research associates (CRAs) not having the breadth of experience needed to ensure full compliance – or not being able to think out of the box in terms of efficiency – it is vital for study sponsors to select an outsourcing partner that has a safety as their core business. Otherwise, there is a real risk of unpleasant budget surprises, non-compliance and compromised safety.
About the Author
Natalia Vlcek is Pharmacovigilance Manager and EU QPPV at Arriello Group. Vlcek has 16 years of experience in the fields of pharmacovigilance and quality assurance, ranging from primary care products to the orphan space. She has worked within pharmaceutical companies as well as CROs. [email protected]; www.arriello.com
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