- Info
Business case and issues
Electronic Data Capture / e-Clinicals
business case and issues - ibr ag
- Phase I - III clinical trials:
One of the key objectives of Clinical Operations is to keep clinical
development time as short as possible while maintaining or increasing
data quality. Part of the solution is EDC, as a considerable amount of
time during clinical development is spent on data cleaning. In clinical
studies, well planned EDC allows for a reduction in queries while
improving data quality, avoids double data entry and shortens study
closure timelines.
- Post Marketing Studies / Safety Surveillance Projects / Patient Registries :
Phase IV studies to corroborate a marketing message or generate data
for further claims are often part of the pharmaceutical product
marketing strategy. These studies should reach a large target group
while being at the same time easy from a logistics stand point and cost
efficient. Pharmaceutical companies face a similar situation with
Safety Surveillance Studies or Patient Registries, more and more
requested by Health Authorities as part of the condition to get the
product license.
Modern
web-based EDC systems allow companies to implement such large-scale
projects in a cost efficient manner, while addressing marketing and
regulatory objectives.
- Patient reported outcomes:
Development of medication in certain therapeutic areas requires the
reporting of data by patients. Studies show that paper and pencil
reporting by patient is less than satisfactory as compliance (e.g. time
point of data collection) is low. Health Authorities are therefore
prefer, if not request, the use of EDC (e.g. electronic patient
diaries) for patient reported outcomes.
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