Investigator Initiated Studies (IIS) are an integral and increasingly important part of the clinical research landscape with clear benefits for sponsors, investigators and patients, but it can be challenging to provide the level of service and support needed to effectively manage supply for these programs on a global scale, particularly for newer specialist medicines.
To capture the full value of IIS while strengthening relationships with the investigator community, sponsor companies must have a supply strategy in place to address the time and resource demands of these variable study populations.
At the same time, there is a need to ensure that Sponsors receive the support they need balanced with the need to control IMP inventories and production scheduling.
- Emerging trends driving growth and value of investigator programs
- Identifying and avoiding potential IIT supply roadblocks that could impact negatively both timing and costs
- Strategic considerations for choosing an outsourced partner for investigator-initiated supply
Don’t miss the opportunity to learn about effective Supply Strategies for Investigator Initiated Studies in this free webinar – register here.
Head of Clinical Trial Services
Mark is responsible for leading the global development of Clinigen Clinical Trial Services. This includes the advancement and implementation of key enhancements such as DDLD (Demand Driven Labelling and Distribution), specialized workstreams such as Biosimilar sourcing strategies and stand alone offerings such as an outsourcing solution for IISs (Investigator Initiated Studies).
With over 20 years' experience in the Pharma industry Mark's prior roles have included working for a Pharmaceutical consultancy, leading business development for a clinical trial cognition assessment firm and running a Benchmarking service for Medical Directors.
Director, Clinigen Consulting
Romina joined Idis in 2012 and spent over two years in programme management. She then moved to head the newly created Medical Operations department with responsibility for the Drug Safety, Medical Information and Medical Data Management teams.
Romina is currently the Director of Clinigen Consulting where she heads an international team of consultants and data experts specialising in unlicensed medicines. Romina is responsible for developing new strategic services to support the corporate objectives and global expansion of the Clinigen Group.
Romina holds a PhD and an MBA and has co-authored a number of international peer-reviewed publications and several conference abstracts and presentations.
Clinical Trial Project Manager
Naomi joined Clinigen in September 2016 bringing a unique blend of skills and experience having worked directly with patients on site in hospitals and also from within a Pharmaceutical company. In her last two roles, Naomi worked as a senior clinical research nurse at Great Ormond street leading a nursing team , assisting physicians in the running of clinical trials and aiding patient recruitment, before moving to Biomarin where she worked as a clinical science project manager supporting clinical operations and working with patient advocacy groups.
Naomi is still currently working clinically and in her Clinigen role is supporting many pharmaceutical companies and hospitals to access medicines for clinical trials. Naomi’s expertise in IITs working in both areas enhances her ability to give proactive advice to overcome many challenges in this complex area.
- Learn about the emerging trends driving growth and value of investigator programs
- Identify and avoid potential IIT supply roadblocks that could negatively impact resource allocation, timing and costs
- Understand strategic considerations for choosing an outsourced partner for investigator-initiated supply
- Head of Medical Affairs
- Chief Medical Officer
- Product Development
- Head of Clinical Development
- Head of Safety
- Head of Regulatory
- Chief Compliance Officer
- Medical Director
- Head of Investigator Initiated Studies
- Head of Investigator Sponsored Studies
- Head of Clinical Trial Supply
- Head of Strategic Sourcing