From Yahoo Finance: 2025-05-02 12:43:00

Clinical trial operations face challenges in maintaining trustworthy relationships with partners, vendors, and sites, according to invIOs’ Sarah Bischof. Dr. Claudia Hesselmann of ARENSIA criticizes current inefficiencies, suggesting an 80% improvement if counterparts demonstrate more initiative. Moldova’s regulatory environment for clinical trials is highlighted by Hesselmann as proactive and efficient. Bischof notes challenges with new EU Clinical Trials Regulation implementation, such as tight deadlines and data protection requirements.

Efficiency in clinical research can be significantly improved by proactive agencies like those in Moldova, as highlighted by Dr. Claudia Hesselmann. Sarah Bischof discusses challenges with the new EU Clinical Trials Regulation, emphasizing the need for early preparation and cross-functional coordination to meet tight deadlines. The importance of adapting to the new directive for improved trial planning is emphasized, while acknowledging the challenges for companies without centralized clinical operations.

Dr. Claudia Hesselmann stresses the importance of sponsor operational teams in clinical trial execution, highlighting the impact of limited resources on small to mid-sized biopharma companies. High turnover rates among project managers, scientists, and regulatory staff are acknowledged, leading to disruption and disengagement. The dedication of site staff and principal investigators can rely on project leaders’ commitment, necessitating role redesign and cross-functional collaborations.

Challenges faced by small and mid-sized companies in selecting and managing CROs and vendors are discussed by Dr. Claudia Hesselmann, emphasizing the importance of patient-centric approaches. External partnerships and empathetic leadership are key to retaining trust during transitions, while problem-solving mentality is crucial when dealing with limited resources. The 15th Annual Outsourcing in Clinical Trials Europe recently took place in Barcelona, Spain from April 29-30.

The article “OCT Europe: Small and mid-sized sponsors demand smart and reliable partnerships” by Clinical Trials Arena highlights the insights shared at the 15th Annual Outsourcing in Clinical Trials Europe event. The importance of efficient clinical trial operations, proactive regulatory environments, and adaptability to new regulations are key takeaways from the discussions.



Read more at Yahoo Finance: Small and mid-sized sponsors demand smart and reliable partnerships