The protocol is perfect –
until it hits the real world.
At Ridge Research Solutions, we partner with sites that receive polished, sponsor-approved protocols… that often ignore the realities of daily operations. A detailed workflow with dry runs to test the theories aren’t just a nice-to-have – it’s a crucial strategy to navigate the real day one, successfully.
Because while protocols lay out:
✅ Visit schedules
✅ Assessment windows
✅ Inclusion/exclusion rules
They aren’t designed to consider:
⚠️ Staff turnover
⚠️ Patient transportation/access
⚠️ Screen fail fatigue
⚠️ Competing demands across studies
⚠️ Unfunded reconsents, labs, or visits
So what happens when the protocol isn’t a perfect fit — and you have to make it work?
Make a plan – work the plan
🔍 1. Operational Deconstruction
→ Break the protocol into core task layers — screening, scheduling, consent flow, visit frequency, logistics, and documentation — to pinpoint friction points early.
📑 2. Proactive Site SOP Mapping
→ Align site SOPs with what the protocol requires, not just what’s typical — and identify where retraining or adjustment is needed. Early internal and external conversations can avoid future misunderstandings.
📑 3. Proactive timeline Mapping
→ The experts know that planning according to dates and knowing where the urgent needs will be and where the flexible spaces are is key to staying on top of it.
📢 4. Communicate Early and Often
→ Flag concerns to the sponsor, your CRA or PM ASAP. The earlier it’s escalated, the more support (and documentation flexibility) you can access.
🔁 5. Adapt the Workflow, Not the Data
→ Streamline what you can control: patient reminders, coordinator scheduling, automated source templates, pre-visit huddles, contingency planning when the heat of the moment and the need for an answered question involves a patient waiting.
🤝 6. Build Internal Advocacy
→ Involve your PI in resource and timeline conversations — their voice can reinforce your site’s boundaries and push for mid-study support. Communicate realistic timelines at the beginning; be up-front about limitations and realistic ability; be a partner for the stated expectations so they are not a surprise.
At Ridge, we help sites not just cope with complex protocols — but navigate the relationships that go with it, strengthening them with strategic clarity.
Because no matter how good a plan looks on paper,
it only works if the people executing it have what they need.
Let us help you with a plan. Contact us here.