It takes two to Tango!
Today, to a large extent, clinical trials conducted by small and midsized Biopharmaceutical and Medical Device Companies are outsourced to CROs and other vendors. When entering the clinical stage of product development, such companies usually face great challenges regarding limited budgets and resources. Therefore, outsourcing and effective vendor management are essential for these companies to survive. However, during the study conduct, many small sponsor companies recognise a big gap between their needs and the actual support they obtain from their vendors.
To prevent such situations, in our experience it is paramount to implement an effective and efficient vendor management system at the early stage of a project. The vendor management system enables the sponsor not only to successfully manage the vendor but also to keep full oversight of a clinical trial and being able to mitigate any risk timely. Importantly, establishing a long-term relationship, fostering open communication and trust building with vendors can result in more effective relationship management, operational efficiencies and cost savings.
Successful vendor management includes quality, costs and time optimisation in order to meet the company’s business objectives. Hence in our webinar, we will provide guidance on how to select appropriate CROs and other vendors, how to effectively contract and manage vendors, develop risk-based assessments, measure vendor performance and create a relationship fostered upon trust and communication. Together we will frame a risk-based vendor management system through identifying, assessing and defining risk-mitigation strategies and monitoring the outcome.
Lumis Life Science Consulting is your partner in clinical oversight. Register today to successfully manage your next clinical trial.
Presented by
Heike Schön,
Managing Director
Heike Schön, has worked in management positions in clinical research for more than 20 years. Her experience ranges from conducting national and international Phase I clinical trials all the way to registration and post marketing activities in various indications. She had positions within the contract research organisations (CROs) and in the biotechnology industry. Her previous positions included operational and general management. She holds a master’s degree in psychology and a master’s degree in business administration. It is her passion to improve the outcomes of clinical trials and to optimise the cooperation between sponsors and vendors.
Heike is a regular speaker at international conferences and publishes within clinical research and medical device magazines.
Dr. Christiane Juhls,
Project Director
Christiane Juhls has been leading and managing international projects for more than 20 years. She has considerable experience as a scientist and Director of Translational Research and Development in the Biotech industry. A veterinarian by training, she has developed immunological medicines for both prevention and therapy up to the early clinical stage.
Her hands-on knowledge in preparing the translation of preclinical results in the early clinical application, in transitioning laboratory-produced molecules in formulated GMP-produced active pharmaceutical ingredients, in transfer of technologies as well as her experience in interactions with CMOs, CROs, other vendors as well as with regulatory authorities has advanced several projects.
Christiane has mentored small-sized companies with medical products in preclinical phases. Moreover, she has a sound background on project funding from both the applicants and the funders side, with a focus on infectious diseases, vaccine development and antibiotic resistance.
