This course aims to provide expertise in the use of EDC and EHR during the development of clinical practice, and describe solutions on how to optimize and ensure the quality of data recorded on the achievement of balance of Pharmaceutical Industries and local expectations of study and the limitations to the current requirements Application for Marketing and always following the GCP guidelines.
Why Should You Attend:
New technologies for information systems are available and continuously improved to support the collection, correction and evaluation of clinical trial data, such as a faster and more efficient process. Each member of a team involved in clinical trials should be aware of the role in this process because of the current objectives is to integrate new databases during a trial, and especially to optimize the speed to minimize the analysis time and costs drug development. This course will cover the concepts involved in these technologies and systems used to meet the challenges and to provide ideas for solving problems related to the use of this technology..
Areas Covered in the Seminar:
- Main structure for EDC and EHR systems in Clinical Trials.
- Expectations for EDC and EHR systems and the role of each member during the course of the Clinical Trials.
- Types of studies and Protocol Design.
- Patient recruitment as per inclusion/exclusion criteria .
- Monitoring electronic data and queries management.
- EData Cleaning process.
- Lessons Learned.
Who Will Benefit:
This webinar intends to provide expertise regarding clinical data for any member involved in clinical trials development among Pharmaceutical Industries
- CROs
- Vendors
- Study Sites
- Steering Committees
- Consultants
- Regulatory agencies
Instructor Profile:
Ingrid Koster, Epidemiologist, has worked in Clinical Research operations as Investigator and also as sponsor in the Pharmaceutical Industries along almost 15 years in Latin America. Ms Koster combines her background and current position in Public Health with her expertise in Research and Development within Pharmaceutical Industries to bring to us not only experiences in Clinical Trials management in several Therapeutic Areas but important insights to improve knowledge and perception for the major points regarding Clinical Research development.
