How do you choose the optimal EDC platform?
Pros and Cons when choosing a do-it-yourself (DIY) EDC versus a commercial EDC
Clinical data is your most valuable asset. High quality, reliable and statistically sound data is critical to successful clinical research.
When conducting a regulatory clinical study, data collection and data processing should be compliant with FDA 21 CFR Part 11, GCP, GDPR and HIPAA.
Today there are numerous CDMS (Clinical Data Management Systems) and EDC software (Electronic Data Capture) platforms for clinical data processing available in the market. An early assessment of the Sponsor needs and the suitability of the platform to the study design will help you choose the optimal EDC system.
Is randomization required?
How many laboratories will be involved in the study? Are there differences in “normal ranges”?
Do I need to merge data from other external sources (devices, central lab, PK, etc.)?
When selecting an EDC you should also ask yourself two crucial questions:
1.How professional and experienced is my team? The less skilled and experienced the team is, the more support will be required when formatting, processing, and cleaning the data. Using a DIY EDC system involves a high level of data management skill from your team.
2.How complicated is your study design? A simple, uncomplicated, straight-forward clinical study allows you to construct a DIY EDC system more easily. A simple CRF which requires minor database setup and validation (including edit check programming) will be implemented relatively easily by an experienced team.
It is important to note:
The most important facet of the data management system chosen is its ability to maintain data traceability.
From the perspective of the sponsor, the EDC should follow the implementation and changes of the clinical operation methodology.
EDC systems can be roughly broken down into two categories – the do-it-yourself (DIY) type and the commercial type – each with its own pros and cons:
•Good solution for small, budget-oriented clinical trials
•A skilled, technology-oriented team may benefit from the advantages of EDC over Excel spreadsheets
•Usually no availability of extra modules (pharmacovigilance, central lab, etc.)
•Getting the recognition of the regulators and meeting auditors’ standards
•Effective management tool for multi-center studies (password permission, IWRS, logistics, pharmacovigilance, etc.)
•Advanced technology tools enable integration with other advanced technology tools (e.g. CTMS, eCRF, electronic diaries, randomization, medical coding, etc.)
•Pricing: A good preliminary market survey will allow you to optimize the best tailored, cost-effective platform.
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