Driving success through well-planned study start-up

  • Defining a start-up plan based on key study objectives
  • Using a data driven approach for effective start-up planning, including data from regulatory intelligence, site intelligence, and KPIs to support start-up planning
  • How effective start-up execution drives a successful trial

Reducing trial start-up time through an innovative approach to vendor qualification

  • Exposing the inefficiencies of current vendor qualification practices and challenging the industry to adopt a proven process innovation that will help sponsors onboard vendors more quickly leading to a real reduction in clinical trial start-up times
  • Learn how embracing innovation, and adopting a risk-based data-driven approach to vendor management can help organizations strength their compliance practices in a heavily regulated industry
  • Uncover the advantages of a centralized approach to vendor qualification that provides unique benefits to both sponsors and vendors across the globe

Choosing the right CRO: key considerations for small biotechs

  • Evaluating CRO capabilities and experience relevant to your specific therapeutic area and development stage
  • Balancing cost, quality and timelines within tight budget constraints
  • Negotiating contracts with flexibility to protect your biotech’s goals

PANEL: Choosing an outsourcing model: FSO vs FSP vs inhouse

  • Weighing up pros and cons of different outsourcing models: which is best for your trial?
  • When is mixing and matching better than fully outsourcing or keeping trials fully in house?
  • Developing an outsourcing strategy as a small to medium sized biotech with limited resources
  • Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?

Studies Beyond Borders: Managing the logistics of conducting worldwide clinical trials

  • Navigating global data restrictions: Lowering concerns and finding solutions regarding the limitations on research imposed by GDPR in the EU
  • Sharing best practice for scaling studies across multiple states and countries despite a lack of consistency with regulations
  • Looking at the intersection of data privacy and sample ownership regulations with the business imperative to address new questions that may arise during study analysis
  • Addressing concerns at the protocol and ICF development phase