“We are committed to deliver the objective evidences that you need, in order to ensure that a proper level of control is maintained over the integrity of your clinical study data. We work collaboratively with you and all the parties involved to achieve this goal.”
Our value added derives from the following approaches, and is meant to enable compliance with ICH E6 Addendum R2:
- Emphasis is placed as much as possible on preventive actions
- Quality tolerance levels are defined
- Appropriate methods are used for root cause analysis
- A comprehensive data integrity oversight documentation is delivered for your trial master file
- We deliver on a fixed cost model, which contributes to maintaining your study costs under good control.
If you need, we can coordinate the execution of corrective and preventive action plans identified and agreed as a result of the data quality oversight reports that we have delivered. We can also roll out actions plan items which require a data management or statistical programming skill set.
If you wish to be transferred our methodology, along with our template deliverables, we can also setup and deliver an adoption program tailored to your team and clinical programs.
If you wish to stay tuned, please follow us on our Enterprise page: alcoam by design, here, on LinkedIn.
To get in touch, please email us.
President at alcoam by design SAS