Live Evidence of the Ongoing Systemic Transformation in Product Life Cycle
The way how Clinical Trials and Product Development are run is entering extraordinary times.
Evolutions in technology, regulations and processes bring along unprecedented challenges and opportunities for all parties involved. For the patients and their caregiver, the sites, the health care professional, the regulator, the sponsor, the vendors and CROs.
As we progressively shift away from treatment towards prevention, from sickness towards wellness, the tech industry is gaining ground, getting closer to patients (and patient data). How should pharma react? Competing or joining up?
While the shorter-term benefits of digitalisation are gradually becoming tangible, there are also longer-term aspirations to transform the entire operating model of clinical research.
For the 6th Nordic ePharma Day conference 2020 we posed with the following questions:
- How Digital Transformation in Nordic area ensure better patient recruitment?
- What solutions and strategies are now in place to implement new tools and speed up the processes to avoid CT delay?
- How pharma manages the oversights (KPIs, CRO selection and contracting, special study designs)?
- What are Business models, new modalities?
- Patient involvement (ethical hurdles, practical examples, patient recruitment). Have Patients accessible information on ongoing clinical trials in an easy language?
- How to approach the Digital Transformation: Personalised medicine, E-health, digital biomarkers?
- How to manage the new inspection mood? Update on typical IT focus areas and deviations seen during GCP inspections considered the digitalization AI and GDPR impact
- What is the value of RWE, RWD and why is it needed?
- What are ePRO solutions/requirements? Clinical Development collaboration with patients especially in regards of PROs (QoL, RWE, Pv, AE)
- Where do we stand with alternative market access strategies?
- What is the approach in Pragmatic Trial?
We are sure you will be as passionate as we are on these novel topics, the future is here, we need to shape it for providing enhanced solutions for a better health and quality of life for patients. This meeting will be a key opportunity to network and learn from knowledgeable speakers and experts of the area.
Simona Sgarbi, Senior Real World Evidence Lead at Lundbeck
Rasmus Hogreffe, Head of Virtual Clinical Trials at LEO Innovation Lab
Who should attend?
Representatives of Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic centers, Hospital Centers, and Clinical Technology companies. Especially Clinical Research Professionals, belonging to the following departments: Clinical Research and Development, Quality Assurance, Regulatory, Pharmacovigilance, Clinical Operations, Statistics and Data Management, Information Technology, Market Access