One of the key challenges in clinical trial operations today is maintaining a trustworthy and reliable relationship with partners, vendors, and sites, says Sarah Bischof, Head of Clinical Developments at invIOs, a private biotech company developing next-generation cancer therapies.
At a closing panel discussion on the first day of the Outsourcing in Clinical Trials (OCT) Europe 2025 meeting, Dr. Claudia Hesselmann, Founder and CEO of ARENSIA, an early phase clinical trial partner, reproached the current inefficiencies in clinical trials. She stated that “efficiency in clinical research could be improved at least by 80%” if only counterparts demonstrated greater initiative and accountability, actively questioning existing limitations rather than accepting established practices.
In her opinion, one of the best regulatory environments to conduct clinical trials is Moldova, which has a ten day fast-track review timeline for clinical trials of all phases. As the Clinical Trials Information System (CTIS) portal was implemented in the European Union, the authorities in Moldova wanted to attract more clinical trials and drive innovation in the country and become as competitive as other countries such as Australia, said Hesselmann. Moldova’s regulatory bodies are an example of how proactive agencies are essential to implement changes that can drive efficiencies, she said.
While discussing their experience with CTIS, Bischof shared that when submitting trial protocols for immunotherapies and autologous cell therapy trials through the new EU Clinical Trials Regulation (CTR) with their contract research organisation (CRO), her team was faced with new administration and documentation burdens with new workflows, portals, and registration processes. With the new CTR implementation, Bischof observed lesser flexibility in terms of responding for trial sites and manufacturing because of the tight deadlines, such as twelve calendar days to provide the request for information. Data protection for confidential documentation with the new directive created a need to re-adapt trial strategies to redact and protect their data.
Early preparation for CTIS submission is crucial because delays may lead to compliance issues, and the a cross-functional coordination of all teams from regulatory to legal is needed to meet these tight deadlines, Bischof shared. However challenging this was, Bischof stated that she would not go back to the old CTR directive because the timelines are more defined in this new directive, leading to improved trial planning. Still, companies without centralised clinical operations are finding it harder to adapt, and success depends on changes to internal processes, retraining teams, and updating document templates, she noted.
Hesselmann highlighted that in her experience from the site’s perspective, she has observed a dramatic difference in whether the sponsor has an operational team. “The sponsor has a different approach to timelines because they own the compound, whereas the CRO does not,” said Hesselmann.
In small to mid-sized biopharma companies, resources are limited; however, according to Hesselmann, even a single clinical trials operation leader from the sponsor side can make a meaningful difference in the smooth clinical trial execution.
Diving into the topic of limited resources of small and mid-sized companies, both speakers acknowledged the high turnover rate amongst key project managers, scientists, and regulatory staff in the industry, which results in project disruption, uncertainty and disengagement. Hesselmann said that sites see a very high turnover rate, especially on the CRO side, with “even three to four manager changes in one project,” which negatively affects the project continuity. “Staff retention in the industry is a huge problem, not only on the programme manager level but even on the monitoring level”, she added.
In some cases, the dedication of the site staff and principal investigator (PI) hinge on the project leader’s commitment. Bischof agreed that when faced with staff turnover as a small and mid-sized company, there is a need to redesign roles to encourage multi-skilling and cross-functional collaborations. Further, she noted that it is important to empower trans-functional market scaling strategies to the remaining team as well as to be agile and adapt fast in terms of structure and processes.
The biggest operational challenge of small and mid-sized companies lies in the selection and management of CROs and other vendors as well as the implementation of patient-centric approaches. Hesselmann pointed out that “the site should not be put in the unfortunate position of inviting patients for screening, only to send them home due to randomisation system failures or other technical or decisional issues caused by the sponsor, CRO, or vendors.”
To conclude the panel, Bischof noted that external partnerships can temporarily ease the load with long-term headcount gaps and a transparent empathetic leadership can retain trust during transition periods, while Hesselmann stressed the importance of possessing a problem-solving mentality when faced with limited resources.
The 15th Annual Outsourcing in Clinical Trials Europe took place in Barcelona, Spain from 29-30 April.
“OCT Europe: Small and mid-sized sponsors demand smart and reliable partnerships” was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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