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The clinical development process requires expertise and skills to be available when you need them.
If your staff is not readily available for the tasks you need completted at the short notice, please contact us. |
EDC
Electronic Data Capture (EDC) services ensure fast, reliable and cost effective results for our customers. We offer user friendly, 21 CFR Part 11 compliant tools capable of producing data fit for FDA submis- sions. Also, EDC is a cost effective investment that systematically reduces the need for expensive study budgets through a regular stream of studies done on the same platform. With a variety of sup- port programs to choose from, you can choose the one most appropriate to the skillsets of CRAs and investigators at the site.
ADVANTAGES OF EDC SYSTEMS:
- No ORE storage, damage or loss
- Allows for secured data transfer with real-time access to data
- Tracks CRF design with flexibility in layout
- Provides for final sign-off of captured data via e -signature
- Part 21 CFR Part 11 compliant automatic tracking (audit trail) of queries, comments and data changes
- Reduces duplicate queries on multiple CRFs
- Provides for batch loading of lab data and normal ranges
- Provides for reusable data formats
IWRS/IVRS
We are proud to offers full-featured global Interactive Web Response Systems (IWRS) and Interactive Voice Response Systems (IVRS) for your clinical studies. Once this validated 21 CRF Part 11 compliant system is implemented it shall be available 24/7 for use by sites, study participants and project team members.
Our expert team of statisticians and IWRS/IVRS programmers can develop permuted block and dynamic algorithms to suit the needs of data management for your study. The system is set up so that it can automatically provide real-time confirmation (by fax or email) of randomization activity.
The IWRS/IVRS can also be used to document entries is Study Participant Diaries or Quality of Life questionnaires All data entries are time -stamped for audit trails and immediately entered into the database to become available for analysis and review.
Furthermore, IWRS/IVRS can be set up to provide automated call -outs and reminders that can be used to effectively increase patient diary completion/compliance rates, by sending patient reminders at a certain time.
And, of course, the clinical trial drug supply inventory, randomization and assignment is managed via
IWRS/IVRS.