Sponsors rely on contract research organisations (CROs) to ensure a trial runs smoothly at all stages, through planning, execution, and final data analysis. It is therefore vital that a sponsor can trust a CRO to ensure that every part of a study is being conducted properly and on time. However, sponsors are concerned about this.
At Veeva’s Clinical Operations Outsourcing 2024 Forum, which took place in Milan, Italy, on 20 November, there were signs of a lack of trust between sponsors and CROs. Still, it was clear that all parties wanted to work out how to regain the trust needed to run studies efficiently, highlighting the importance of sponsor oversight.
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Sponsor oversight encompasses all the activities undertaken during the clinical trial to ensure the protection of patients, the reliability of the data, and that the trial is conducted per the legislation. It is the sponsor’s safety net to check that any trial protocol, procedures or training, which have been conducted by either outsourced or internal personnel are running correctly. If something is not logged properly on the sponsor oversight, a regulatory agency will assume it did not happen.
Ed Fowler, VP of operation excellence at global CRO Parexel spoke about finding the right balance when it comes to sponsor oversight of a trial, providing a Goldilocks-style analogy that neither too much, nor too little oversight by an effective sponsor – it must be ‘just right’.
Fowler said: “If you want successful and effective study delivery, you must get sponsor oversight just right. Too little is no good, too much is no good. Too little oversight and you have misaligned deliverables, deviation from project goals, quality issues, and disjointed teams, that can all happen if there is not enough oversight.
“Too much oversight gets expensive, if you are always at meetings and looking at data, that is a high cost for both organisations. It is quite a controversial opinion but too much oversight can stifle the CRO’s creativity and efficiency. It can slow down decision processes because people want to wait for the next meeting. There is also relationship strain from being in so many meetings and having so many questions about processes. We need to find the middle of this.”
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By GlobalDataEmma Forrest, head of R&D operations at sponsor Recordati, seemed to have struck a chord with Parexel in her presentation about the difficulties on the sponsor side when a CRO does not pull its weight or makes a mistake in a study. She spoke about how having an eTMF system in place can avoid those kinds of issues.
“There was no way we could run a fully outsourced model by relying on the CROs, no one is going to treat your trial with as much heart as you do,” Forrest said.
From the first meeting
Evgenia Delyagina, head of TMF [Trial Master File] operations at sponsor Debiopharm discussed how agreements must be made about how sponsors and CROs will collaborate from the first meeting.
“How do we enable collaboration? It starts very early when we start our discussions with a CRO. There will be a clear requirement that a CRO has to work in our interior system. If the CRO is not okay with that, they are out,” Delyagina explained.
This ensures that Debiopharm always has access and control over the documents they need and can provide efficient oversight for the study, Delyagina added.
As has been the case for years, if a trial fails or there is an operational failure, it falls upon the sponsor, not the CRO. Therefore, trust is key in sponsor-CRO relationships added Fowler, before passing over to Pooja Purewal, associate project director for biotechs at Parexel.
Purewal explained how being transparent is vital when it comes to maintaining a balance between CROs and sponsors – saying effective sponsor oversight is important in this. This relationship needs to be determined from the outset so that a CRO can understand the frequency of conversation that a sponsor will want.
She said: “You have your study level oversight but on a partnership level, a governance level, what as a CRO is it that you need to deliver or provide oversight on so that both parties are accountable and know what is going on.”
Purewal said that defined roles and responsibilities need to be established on both sites from the very start of a study, as well as having a pulse check during the study to ensure that all parties are still happy.
As trials get more complex, it becomes even more important to ensure efficient sponsor oversight said Pinar Bérénice Bénet, senior director of strategy,
clinical operations at Veeva Systems.
“More companies are conducting more complex studies to be able to reduce timelines to reach the market. Instead of using the standard waterfall system – Phase I, Phase II and Phase III – companies are now putting all those stages together in an umbrella trial with multiple arms. On top of this more complex trial design, these are common in more specialist therapies such as cell and gene therapies. As a result, the risk is significantly compounded so oversight is even more important,” Bénet said.
