AetiolTM-EDC
The most successful clinical trials begin and end with the highest quality, clean data.
AetiolTM-Capture
AetiolTM provides the fastest start up, rapid database lock, and more rapid FDA submissions, resulting in a greater ROI.
AetiolTM-Encoder
Using Medical dictionaries (MedDRA), the AetiolTM- Encoding Module encodes verbatim text that has been entered into the eCRF.
Currently, Prelude builds the eCRFs using examples of paper CRFs (Case Report Forms) provided by the sponsor.
This helps to standardize the eCRFs and leverages Prelude’s experience across hundreds of studies.
Future projects which utilize eCRFs are less expensive due to reuse.
eCRFs and paper CRFs are not the same. eCRFs have logic and edit checks built-in to run behind the scenes.
This allows the entered value to be cross-checked against normal ranges, or selected from a drop-down database, etc.
This logic and cross-form edits help to maintain a clean database throughout the entire duration of the study, which builds confidence in the outcome and results.
Future projects which utilize eCRFs are less expensive due to reuse.
eCRFs and paper CRFs are not the same. eCRFs have logic and edit checks built-in to run behind the scenes.
This allows the entered value to be cross-checked against normal ranges, or selected from a drop-down database, etc.
This logic and cross-form edits help to maintain a clean database throughout the entire duration of the study, which builds confidence in the outcome and results.
Yes, AetiolTM-EDC works closely with the Sponsor to drive standardization of eCRFs.
AetiolTM-EDC takes the next step by incorporating Sponsor-specific defined data terminology or naming conventions which help support biostats and data analysis.
AetiolTM-EDC takes the next step by incorporating Sponsor-specific defined data terminology or naming conventions which help support biostats and data analysis.
Your study database is available anytime, all the time
- The server is live 24 hours per day, 7 days per week, 365 days per year.
- Access is controlled by permission-based, secure user IDs and passwords.
- Based on your User role, you may only have access to select forms and functionality.
Yes, AetiolTM-EDC meets the current guidelines for Part 11 for:
We rarely know the outcome of the submission unless it is shared by the Sponsor Company. We are aware that AetiolTM-EDC has been used for:
- Electronic signatures
- Proper Audit tracking
- Life Cycle Process
We rarely know the outcome of the submission unless it is shared by the Sponsor Company. We are aware that AetiolTM-EDC has been used for:
- GLP / GCP submissions
- USDA submissions
- EPA submissions
- EMA submissions
Minimal training is needed to begin using AetiolTM-EDC. Development support is available in the form of:
- Online tutorials and videos
- Periodic training and refined user guides provided by support staff.
- Contact with AetiolTM-EDC support staff regarding your issues or questions.
No programming, networking, or database experience is needed to use AetiolTM-EDC. Simple design interfaces within AetiolTM-EDC handle all of these details automatically.
Data from your study can be easily exported into Microsoft Excel.
No programming, networking, or database experience is needed to use AetiolTM-EDC. Simple design interfaces within AetiolTM-EDC handle all of these details automatically.
Data from your study can be easily exported into Microsoft Excel.
AetiolTM capture is a online system that works on intranet technology.
Yes, AetiolTM-EDC meets the current guidelines for Part 11 for:
We rarely know the outcome of the submission unless it is shared by the Sponsor Company. We are aware that AetiolTM-EDC has been used for:
- Electronic signatures
- Proper Audit tracking
- Life Cycle Process
We rarely know the outcome of the submission unless it is shared by the Sponsor Company. We are aware that AetiolTM-EDC has been used for:
- GLP / GCP submissions
- USDA submissions
- EPA submissions
- EMA submissions
No programming, networking, or database experience is needed to use AetiolTM-EDC. Simple design interfaces within AetiolTM-EDC handle all of these details automatically.
Data from your study can be easily exported into Microsoft Excel.
At present only Meddra is integrated with AetiolTM Encoder.
AetiolTM Encoder provide 4 types of report that are mention below.
- Coding glossary report:- It fetches the list of unique verbatim terms that can be used for review/correction/clarification of the coding for verbatim terms performed.
- Listing Report:- It comprises of collected study data domain wise, it also includes all the dictionary items(full hierarchy of Meddra dictionary) as columns.
- Coded VTs report:- It comprises of the list of coded verbatim terms.
- Uncoded VTs report:- It comprises the list of uncoded verbatim terms that will be subjected to manual coding.
Yes, the moment CRF is saved after entering the verbatim term the same will be subjected to coding by AetiolTM Encoder instantly.
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