Enrollment Operations Support for Clinical Research Sites

Clinical Trial Intake and Prescreening Support

Hands-on support for small and independent research sites.

Consent2Randomize works within site-approved workflows to handle agreed intake, candidate outreach and follow-up, candidate-reported information collection, documentation, permitted scheduling and reminders, clinical and protocol escalation, and structured handoff to authorized site personnel.

A research site can delegate these approved early enrollment activities to Consent2Randomize as an outside operational team. The site approves candidate communications and scheduling permissions, Consent2Randomize documents candidate-reported information and escalates clinical or protocol questions, and the research site determines eligibility and retains clinical and protocol authority.

This is the primary recurring execution service after a referral or inquiry enters the site's workflow. See the broader enrollment operations model. CROs and sponsors coordinating support for selected sites can review site enrollment support engagement models. Patient advertising or referral generation is scoped separately.

Two clinical research professionals coordinating referral intake and prescreening workflow.

What Our Specialists Handle

Specialists take ownership of the agreed operating steps and keep each referral record current until it is ready for authorized site review or another documented disposition.

Incoming Referral Response

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

Appointment Coordination and Handoff

Coordinate permitted scheduling and reminders for candidates who wish to continue, then prepare a structured handoff for authorized site personnel.

Consent2Randomize support begins after a referral or patient inquiry reaches the site and includes intake, preliminary prescreening, candidate follow-up, appointment coordination, and structured handoff. Formal screening, final eligibility, medical decisions, and informed consent remain with the research site.

Where Consent2Randomize Fits

Support begins after a referral or patient inquiry reaches the site and ends at structured handoff before formal screening and informed consent.

  1. Starting trigger

    • Referral or Patient Inquiry Reaches the Site
  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

Formal screening, final eligibility, medical decisions, and informed consent remain with the research site.

Clear Pricing Based on the Agreed Scope

Each engagement is priced according to the enrollment support, responsibilities, and billable milestones agreed with the site before work begins. Patient advertising, referral generation, and media spend, when requested, are scoped separately.

Define the Workflow and Scope

The site and Consent2Randomize define the study workflow, site-approved preliminary questions, communication permissions, escalation path, handoff expectations, and billable milestones.

Complete the Agreed Support

Consent2Randomize completes the agreed intake, preliminary prescreening, follow-up, appointment coordination, documentation, and handoff activities before consent.

Pay According to the Service Agreement

The site pays according to the rates and operational milestones stated in the service agreement. Separately requested advertising or referral-generation work is not included unless expressly added.

The service agreement documents the operational tasks Consent2Randomize performs, the actions reserved for site personnel, the escalation path, and the records included in each handoff.

Add Intake and Prescreening Support Without Expanding Your Permanent Team

Sites use this service when new referrals require consistent administrative attention but permanent headcount is not the right fit for the workload.

Coordinator Support

We manage the upstream enrollment work so coordinators can remain focused on site evaluation and trial responsibilities.

Flexible Support

Support adjusts to referral volume without requiring the site to maintain additional permanent intake staff.

Clear Activity and Disposition Reporting

Sites receive clear reporting on referral status, contact attempts, preliminary prescreening disposition, scheduled evaluations, and documented reasons a candidate did not advance.

Where Enrollment Support Can Make a Difference

This service provides recurring execution when patient interest is already arriving but ownership, response, status documentation, or handoff consistency is under strain.

New patient interest is waiting for follow-up

Referrals and inquiries have arrived, but coordinator priorities make consistent follow-up difficult. Consent2Randomize can organize incoming interest, complete site-approved intake steps, collect preliminary responses, document follow-up, and prepare the next action for site staff.

Prescreening and follow-up vary from one study to another

Different protocols and internal processes can make candidate status harder to track. Consent2Randomize can support consistent preliminary prescreening and follow-up using site-approved criteria, documented statuses, and defined handoff expectations.

Coordinator time is stretched across too many responsibilities

Coordinators may be balancing patient visits, regulatory work, data entry, sponsor communication, and new inquiries. Consent2Randomize can take on approved upstream enrollment tasks before consent, adding capacity without requiring permanent staff.

A referral reaches the site without a clear next step

Information may be incomplete, contact attempts unclear, or the candidate’s current status difficult to determine. Consent2Randomize can provide a structured handoff showing what was completed, what remains open, and what the site should review next.

Structured handoff preserves site control

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

Schedule an Enrollment Alignment Call

Discuss where intake, preliminary prescreening, follow-up, or handoff may be placing unnecessary pressure on your site.

EXPERIENCE BEHIND THE WORKFLOW

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

What Research-Site Professionals Have Valued

Consent2Randomize is built around practical experience supporting clinical research workflows where timely follow-up, clear documentation, and dependable handoffs matter. These comments reflect feedback from professionals who previously received enrollment workflow support.

Clearer Follow-Up and Accountability

“The follow-up process became more consistent and organized. It was easier to understand what needed attention and what the next step should be.”

Former clinical research client

Name and practice withheld for confidentiality

More Support for the Internal Team

“The added support helped our internal team manage competing priorities while keeping important enrollment-related tasks moving forward.”

Former research-site client

Name and practice withheld for confidentiality

Clearer Documentation and Handoffs

“The information was clearly documented and easy to review. We had a better understanding of what had been completed and what still required attention.”

Clinical research professional

Name and practice withheld for confidentiality

The Work Behind That Feedback

The same operating principles now guide Consent2Randomize’s support for clinical research sites across incoming referral intake, preliminary prescreening using site-approved criteria, candidate follow-up, appointment coordination, documentation, and structured handoff to site staff before consent.

Schedule an Enrollment Alignment Call

Simple, Study-Specific Setup

Before support begins, Consent2Randomize aligns with your team on permitted patient contact, site-approved preliminary questions, documentation, clinical and protocol escalation, scheduling coordination, and handoff to authorized site personnel.

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

Review the study protocol and existing referral workflow.

Align on site-approved preliminary questions, patient communication, documentation, clinical and protocol escalation, and handoff procedures.

Begin managing incoming referrals and patient inquiries.

  • Site-approved preliminary questions
  • Site-approved questions and communication
  • Defined escalation and handoff procedures
  • Consistent referral documentation
  • Site-approved patient communication preferences
  • Clear activity and disposition reporting

Frequently Asked Questions

Common questions about how Consent2Randomize manages intake and prescreening support.

Enrollment Timelines Keep Moving

Enrollment timelines keep moving, even when coordinators are overloaded. Every delayed referral is another potential participant who may never reach site evaluation.

Put structured intake and follow-up support in place without adding permanent staff, so incoming referrals receive timely attention and the site receives a clear next step before consent.

Strengthen What Happens After Patient Interest Reaches Your Site

Reduce coordinator strain, improve follow-up consistency, and keep more enrollment opportunities moving toward consent.

Discuss an active study, referral workflow, or intake-capacity need.