When Your EDC Is Failing Your Study

Most study teams know something is wrong long before they do anything about it. Query rates climbing. Sites logging workarounds instead of data. A protocol amendment sitting in a queue for weeks. In long-duration, complex trials — CNS studies especially — that window of inaction is where the real damage happens. This whitepaper is a strategic decision framework for the executives who have to make the call: stay, remediate, migrate, or rescue.

What You’ll Learn:

How to recognize the difference between an EDC problem you can fix and one you can’t
The true cost of staying on a failing platform — and why CNS teams feel it hardest
When rescue study deployment is the right call, and what a realistic timeline looks like
How to navigate 21 CFR Part 11, ICH E6(R3), and EU Annex 11 during a mid-study transition
What to ask an EDC vendor before you’re in a crisis — not after
A governance framework for pre-migration, active migration, and post-migration phases

Perfect for:

VPs and Directors of Clinical Operations managing Phase II–III studies
Clinical Data Managers evaluating platform performance or planning a transition
Research Leadership at Academic Medical Centers sponsoring investigator-initiated trials
CRO Account Leads navigating sponsor-driven or relationship-driven platform changes
Regulatory Affairs Teams responsible for documenting and defending system transitions

Download the whitepaper for a decision framework you can use immediately — whether you’re actively evaluating a migration or stress-testing your current platform before you need to.

Gated CNS Sales Play Form

First Name(Required)

Last Name(Required)

Email(Required)

Company(Required)

Seniority(Required)

Functional Area(Required)

Country / Region

Marketing / Communications Opt-in

I agree to receive communications from OpenClinica.

eClinical

Patient Recruitment