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The Covid-19 pandemic has irreversibly changed the way clinical trials are conducted. The use of a wide range of technologies such as eConsent, teleconsultations, sensors, devices, and electronic patient diaries enables more patient-centric trials conducted to a larger population by conducting the clinical trial remotely in a participant’s home rather than at the clinic. A decentralized approach to clinical trials poses possibilities and challenges from a patient, investigator, and sponsor perspective. In this webinar, you will learn about decentralized clinical trials challenges and possibilities as well as a few of the technologies used for remote data collection. You will also be introduced to risk-based data management approaches for data review and validation.
When: April 28
Time: 9:00 to 10:00 CET
09.00-09.05: Welcome by Jo Anders Rønneberg
09.05-09.25: Decentralized Clinical Trials: Possibilities and challenges by Gunnar Danielsson
09.25-09.45: Data collection and validation considerations in Decentralized Clinical Trials by Jo Anders Rønnerberg
09.45-10.00: Q&A and Conclusion
About the speakers:
Senior Regulatory Advisor
Gunnar Danielsson, former GCP inspector has traveled around the world performing GCP inspections for the Swedish Medical Product Agency for over 10 years. He has 40 years’ experience in Clinical Research and has a wealth of experience from the Pharmaceutical industry in terms of quality management, electronic systems, data management, and clinical design and conduct. Gunnar today is a key advisory resource and helps to design studies in the most effective way, meeting regulatory requirements.
Jo Anders Rønneberg,
Jo Anders holds a Ph.D. in Molecular Medicine and has over 17 years of experience within research and the CRO industry. With extensive operational experience in running clinical trials, he has been part of LINK Medical since March 2011 and is an experienced biometrics and clinical operations leader.
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