Protocol Optimization & Site Strategy

Protocol Optimization & Site Strategy

Accelerate Enrollment With Smart Design and the Right Sites

At iRecruitCeliac, we know that successful clinical trials begin with two critical steps: designing a patient-centric protocol and selecting high-performing sites. Leveraging decades of expertise in celiac disease research, patient engagement, and clinical trial execution, we partner with sponsors and CROs to refine protocols and identify the right sites based on your study criteria.

By combining optimized study design, site performance data, and hands-on engagement at investigator meetings, we reduce enrollment barriers, shorten timelines, and maximize retention—delivering a recruitment strategy you can trust from day one.

 

Protocol Optimization

Refine your design for real-world success.

Celiac disease studies face unique challenges, from strict inclusion criteria to burdensome visit schedules that can discourage participation. Our team works with sponsors and investigators to anticipate and resolve these obstacles before recruitment begins.

We provide:

  • Patient-Centric Review – Ensuring protocols are feasible and engaging from the patient’s perspective.
  • Expert Guidance – Scientific oversight from globally recognized celiac disease researchers and advisors.
  • Barrier Identification – Early detection of design elements that could limit enrollment or retention.
  • Regulatory Alignment – Recommendations that balance patient experience with the expectations of major regulatory agencies, including the FDA (United States), EMA (Europe), TGA (Australia), and national health authorities across Latin America.

To ensure protocols are truly patient-centric, we integrate structured feedback from our Patient Advisory Boards and Panels. Their insights help sponsors identify and resolve barriers that could impact enrollment or retention.

 

 

Integrated Site Engagement at Investigator Meetings

Turning Protocols Into Action

We don’t just optimize study designs on paper — we ensure sites are prepared to deliver. Our team regularly presents at sponsor investigator meetings, where we walk principal investigators and clinical research coordinators through the recruitment protocol step by step.

At these meetings, we also present results from Patient Advisory Boards and Panels, where patients review the protocol in advance and provide candid feedback on visit schedules, burdens, and potential barriers to enrollment. Sharing these findings directly with investigators ensures sites understand the patient perspective, adopt patient-informed best practices, and are better equipped to engage and retain participants.

Using detailed slide decks and real-world data examples, we:

  • Demonstrate how patient referrals flow from iQualifyCeliac into site workflows.

  • Share coordinator-facing tools for tracking outreach, screen fails, and enrollment outcomes.

  • Highlight best practices for engaging patients and reducing referral drop-off.

  • Provide site-specific performance benchmarks to set clear expectations from the outset.

By combining protocol optimization with proactive training and patient-informed insights at investigator meetings, sponsors gain confidence that sites are aligned, equipped, and motivated to achieve enrollment goals from day one.

 

High-Performing Site Selection

Match with the right sites, backed by performance data

We don’t just recommend sites—we help you select those most capable of meeting enrollment goals. Our team screens sites for interest, capacity, and protocol fit, then provides data-driven performance insights.

Metrics include:

  • Average time to referral contact

  • Referral pick-up rate

  • Logged screen-fail reasons

  • Enrollment outcomes compared across sites

This transparency empowers sponsors to allocate resources where they will have the greatest impact.

 

iQualifyCeliac: Real-Time, Geo-Targeted Referrals

Delivering qualified patients to your selected sites instantly

With intelligent geo-targeting, iQualifyCeliac matches pre-screened patients to sponsor-approved sites in real time. Patients may also indicate site preference during call-center interviews for a personalized match.

Study coordinators receive referrals through our secure portal, which:

  • Delivers qualified patients at peak interest

  • Provides automated reminders to prevent referral loss

  • Alerts sponsors and CROs when referrals are not being picked up

  • Logs screen-fail reasons and enrollment outcomes

  • Manages waitlists automatically by ZIP code for future re-engagement

 

Proactive Study Site Engagement

Keeping coordinators motivated, aligned, and accountable

Our work doesn’t stop at referral delivery. We maintain continuous engagement with sites to ensure coordinators are supported throughout recruitment and enrollment. We:

  • Share best practices

  • Troubleshoot challenges in real time

  • Provide accountability reporting to CROs and sponsors

This relationship-driven model strengthens site motivation and ensures consistency across the network.

 

Clinical Trials Site Advisory Council

Global PI and coordinator expertise shaping study design

We draw on the expertise of our Clinical Trials Site Advisory Council—a global group of principal investigators and coordinators who provide real-world feedback on protocol design and recruitment strategies. Their insights ensure every trial benefits from ground-level experience, improving feasibility, reducing screen fails, and accelerating enrollment.

 

Let’s Accelerate Your Next Study

Partner with iRecruitCeliac to optimize your protocol and streamline site selection. Together, we’ll ensure your trial enrolls faster and more efficiently.