All Pharma Industries are facing challenges when conducting clinical trials, and even more when the trials are complex. How is a mid-size pharma approaching the issues? Indeed complex studies need to be properly designed, and especially when the resources are limited and there is a high competitiveness in the investigational field. Study failure in a mid-size pharma is impacting in a material way the sustainability of the company, we need to ensure this risk is being minimized and carefully controlled in all areas. Involving all players in study design and feasibility is key to success.

Tufts CSDD convened a working group of sponsor and CRO companies to update and expand on previous benchmarks in the vendor qualification assessment process. Three separate surveys were used to collect data from sponsors and CROs, vendors, and clinical trial sites. Analysis of the survey results provides insights into the time and personnel investments required, as well as trends in how new technologies are being used in the VQA process.

A look into a small biotechnology "fit for growth” framework designed to optimize efficiency and scalability. We will explore how small biotech organizations can strategically balance functional insourcing and outsourcing to meet evolving needs across different stages of growth and clinical trial activities. The adaptive model addresses key considerations in personnel hiring, vendor selection and management to ensure seamless operations and maintain quality standards.

Clinical trials constitute the backbone of research and development for evaluating the safety and efficacy of novel interventions. Traditional trial designs have contributed to medical advancements; however, they often encounter challenges such as prolonged timelines, high costs, and limited generalisability. In response, researchers embrace trial designs that offer enhanced efficiency, flexibility, and patient-centricity. This presentation will review some innovative trial designs shaping the research landscape.

Clinical trials constitute the backbone of research and development for evaluating the safety and efficacy of novel interventions. Traditional trial designs have contributed to medical advancements; however, they often encounter challenges such as prolonged timelines, high costs, and limited generalisability. In response, researchers embrace trial designs that offer enhanced efficiency, flexibility, and patient-centricity. This presentation will review some innovative trial designs shaping the research landscape.

In clinical trials and biopharma research, ensuring GDPR compliance when working with vendors that process personal data is crucial. This presentation will cover essential controls for engaging vendors, including conducting due diligence on technical and organizational measures, executing comprehensive data processing agreements, and implementing continuous compliance monitoring. We’ll also explore how to address international data transfers and effectively manage sub-processors. Best practices will be shared to emphasize the importance of robust vendor management in maintaining GDPR compliance.

The non-profit European Forum GCP eConsent Initiative, comprised of 50 companies, has released a suite of global tools to address the misconceptions and lack of harmonization and insight about eConsent. Harmonized terminologies and study documents' requirements, insight in stakeholders’ benefits and challenges, and a 5-step framework to design the right eConsent for a particular study and generate effective eConsent study data are some topics covered in this session.

Radiopharmaceutical Therapy (RPT) is a rapidly expanding area of interest and its future success is highly dependent on the quality of clinical trials in this space. Early-phase RPT clinical trials require multifaceted site qualification as well as highly technical data collection for dosimetry analysis, involving complex imaging techniques. We propose a presentation on the complexities (and opportunities) that these types of study present from a sponsor’s perspective.