EDC

FROM SELECTION TO ACTIVATION

EDC

FROM SELECTION TO ACTIVATION

Your trusted EDC expert to meet your specific analytic end goal.

Out of all current available e-Clinical solutions, Electronic Data Capture or an electronic Case Report Form (EDC/eCRF), is the most used technology to enable successful trial completion.

With more and more EDC vendors coming into play the selection process for many pharma and medical device companies becomes overwhelming.

The EDC system you choose should be the one that gets you to your end goal – analysable data – as quickly and efficiently as possible.

Some of the new EDC systems allow their own build-up with initial training and support. Bringing EDC builds in-house indeed sounds an attractive option. A careful look must however be considered.

Why do you need a data manager with EDC experience?

CRF creation, metadata definition, writing rules, edit checks and their correlated test scripts, developing a data management plan, considering the data analysis you want to end up with, and many other related tasks, need to be part of your next steps following the EDC selection.

A lot to think about and plan with the end in mind when building the EDC.

The combination between the selected EDC technology, written process (SOPs) in place and a skilful and experienced professional for such a task will make the difference between swift success and endless upset and expense.

Get skillful support to walk with you beyond the basic EDC implementation and onboarding.

We deliver services in several widely accepted Electronic Data Capture (EDC) systems. We work closely with our clients to determine specific EDC requirements to customize implementation. The EDC system we use is scalable to accommodate custom offerings to suit your trial’s data and processing.

We believe in an ongoing partnership to ensure that you can make the most of your investment – improving the EDC build process. We will help you with:

  • Vendor Qualification Assessment; to ensure the system is secured and compliant with relevant regulatory requirements, such as ICH-GCP, ISO14155, FDA CFR 21 Part 11, HIPAA, and GDPR.
  • EDC configuration per protocol; creating forms that contain all protocol requirements, and ensuring the selected EDC system collects all the necessary clinical data in a qualitative manner.
  • Validation of EDC system components: to verify and document that the EDC is properly operating.

Contact Us

Our EDC expert will help you to ensure a clean data at the end of your clinical trial, ready for rapid analysis.

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