Clinical Trial Enrollment Support

Clinical Trial Enrollment Support for Research Sites

Consent2Randomize provides study-specific clinical trial enrollment support for research sites. C2R may support patient recruitment, the follow-up and early enrollment work after someone expresses interest, or both.

The scope is defined with your site for the study. Your research team keeps responsibility for the clinical process, including formal screening, final eligibility decisions, and informed consent.

Learn more about the post-interest enrollment operations model. CROs and sponsors coordinating support for selected sites can review site enrollment support engagement models.

Clinical research professionals reviewing study enrollment information.

Three Ways a Study May Use C2R

Different studies may need help with different parts of enrollment. C2R support is defined around the study rather than requiring the same service model every time.

Patient Recruitment Support

When additional candidate flow is useful, C2R can support patient recruitment using the approach approved for the study.

Post-Interest Enrollment Support

If referrals or inquiries are already coming in, C2R can handle agreed early enrollment work after patient interest and before the site’s formal screening and informed-consent process.

Recruitment + Post-Interest Support

When the study needs support across both portions, C2R can help generate potential-participant interest and handle the approved early enrollment work that follows.

The appropriate scope depends on the study and what the research site wants C2R to handle.

What C2R Can Handle for a Study

The scope can be built around the study and the way your site wants the work handled.

Finding Potential Participants

When recruitment is in scope, C2R can help generate potential-participant interest using the approved study-specific recruitment approach.

Supporting What Happens After Interest

When post-interest support is in scope, C2R can handle agreed operational work after a referral or inquiry enters the workflow.

Incoming Response and Intake

Work within the site-approved workflow to respond to new referrals and inquiries, capture required intake information, assign status, and document the next action.

Study Information and Preliminary Prescreening

Provide site-approved study information, collect and document candidate-reported responses through site-approved preliminary questions, and escalate clinical or protocol issues.

Follow-Up and Documentation

Maintain agreed follow-up, document contact attempts and candidate status, and keep the site informed.

Scheduling, Escalation, and Structured Handoff

Coordinate permitted scheduling and reminders for candidates who wish to continue, route clinical or protocol questions back to the research team, and prepare a structured handoff for authorized site personnel.

C2R performs only the recruitment or early enrollment activities included in the agreed study scope.

Your Research Team Stays in Control

C2R handles only the work your site has approved. Your research team remains responsible for formal screening, final eligibility decisions, informed consent, protocol oversight, medical decisions, and randomization.

Patient interest can reach a study through C2R recruitment or another source. When post-interest support is included, Consent2Randomize can handle intake, site-approved preliminary prescreening, candidate follow-up, appointment coordination, documentation, escalation, and structured handoff after a referral or inquiry enters the agreed workflow. Formal screening, final eligibility decisions, informed consent, protocol oversight, medical decisions, and randomization remain with the research site.

Where C2R Fits After Patient Interest

Patient interest can reach a study through C2R recruitment or another source. When post-interest support is included in the scope, C2R’s role begins when a referral or inquiry enters the agreed workflow and ends at a documented handoff before the site’s formal screening and informed-consent process.

  1. Starting point

    • Patient Interest or Referral Enters the Agreed Workflow
  2. Consent2Randomize support

    • Intake
    • Preliminary Prescreening
    • Candidate Follow-Up
    • Appointment Coordination
    • Structured Handoff
  3. Support ends at structured handoff.

  4. Research-site responsibility

    • Site Evaluation and Formal Screening
    • Final Eligibility Determination
    • Informed Consent

After structured handoff, formal screening and the research site's clinical decision-making remain with the research team.

A Clear, Documented Handoff Preserves Site Control

Each handoff shows what was completed, what remains unresolved, and which next action is ready for authorized site review.

Illustrative Handoff Structure

What a Structured Site Handoff Can Contain

The exact fields depend on the study and approved scope. A C2R handoff can organize the operational record so authorized site personnel can see what was completed, what remains open, and what should happen next.

Candidate-reported information collected within the approved workflow
Relevant contact and follow-up history
Completed operational steps and current status
Unresolved items requiring site review
Documented escalation where applicable
Scheduling context and next action where permitted

Illustrative structure only. This is not a patient record, does not contain protected health information (PHI), and does not mean every engagement uses identical fields.

Schedule a brief call

Discuss how recruitment and early enrollment are expected to work for the study and which parts, if any, would be useful for C2R to handle.

EXPERIENCE BEHIND THE ENROLLMENT APPROACH

Built From Hands-On Prescreening Experience Across Different Protocols and Patient Populations

Consent2Randomize's approach is informed by historical hands-on support for research-site prescreening and pre-consent workflows across pharmaceutical-sponsored studies in multiple therapeutic areas.

Rheumatology & AutoimmuneWomen’s HealthNeurologyMusculoskeletal & PainMetabolic ConditionsInfectious Disease

Protocol-driven, not indication-limited.

Learn about the experience behind the approach

Simple, Study-Specific Setup

The first setup question is simple: what does this study need C2R to handle? The setup then reflects whether the agreed scope includes recruitment, post-interest enrollment support, or both.

Two clinical research professionals reviewing a study-specific intake and prescreening workflow.

Define the Study Scope

Define the study, whether C2R will support recruitment, post-interest enrollment work, or both, and where the research team’s responsibilities begin.

Configure Recruitment If Included

Align on the approved recruitment approach, geography, study information, permitted materials and channels, routing, and handoff expectations that apply to the engagement.

Configure the Post-Interest Workflow If Included

Align on permitted patient communication, site-approved preliminary questions, follow-up, scheduling, documentation, clinical and protocol escalation, reporting, and structured handoff.

Confirm Readiness and Begin

Begin only the approved work after the required scope, permissions, materials, access, and readiness steps are in place.

  • Defined recruitment scope when applicable
  • Site-approved preliminary questions
  • Approved patient communication
  • Defined escalation procedures
  • Defined documentation and reporting
  • Clear handoff expectations
  • Required systems or access when applicable

Pricing Based on the Agreed Study Scope

Each engagement is priced according to the enrollment support, responsibilities, and billable milestones agreed with the site before work begins.

The scope may include recruitment only, post-interest enrollment support only, or both.

Define the Study Scope and Billable Milestones

The site and Consent2Randomize agree on what C2R will handle, the responsibilities on each side, the applicable workflow, handoff expectations, and billable milestones.

Complete the Approved Support

Consent2Randomize completes only the recruitment and/or post-interest enrollment work included in the study agreement.

Pay According to the Service Agreement

The site pays according to the rates and milestones stated in the service agreement. If patient recruitment includes approved media spend or other study-specific recruitment costs, those items are defined for that study before the applicable work begins.

The service agreement documents the work Consent2Randomize performs, the responsibilities retained by site personnel, applicable escalation and handoff procedures, and the agreed payment terms.

Frequently Asked Questions

Common questions about how research sites can use Consent2Randomize for patient recruitment, post-interest enrollment support, or both.

Have an Active or Upcoming Study?

Tell us how you expect recruitment and early enrollment to work for the study. We can look at whether C2R would be useful for recruitment, post-interest support, or both.

No protected health information is needed for the conversation.