Site-Approved Workflows
Support follows the preliminary criteria, communication, documentation, escalation, and handoff procedures agreed with the research site.
ABOUT CONSENT2RANDOMIZE
Why Consent2Randomize Exists
Finding potential participants and handling what happens after they express interest are different jobs. C2R can help with either part, or both, depending on the study.
What Nicholas Saw in Research-Site Work
Through hands-on work around research-site prescreening and pre-consent workflows, Nicholas Mansilla kept coming back to one practical distinction: generating patient interest and handling what happens after that interest reaches the site are different jobs.
Before a site reaches formal screening or consent, someone still has to respond, collect preliminary information, follow up, coordinate permitted scheduling, document what happened, and prepare a clear next step for the research team.
That observation shaped Consent2Randomize: give research sites the option to use C2R for patient recruitment, approved early enrollment work after someone expresses interest, or both, while the site keeps control of its clinical process.
EXPERIENCE BEHIND THE APPROACH
Hands-On Experience Across Clinical Trial Prescreening Workflows
Consent2Randomize brings historical hands-on experience supporting research-site prescreening and pre-consent workflows across pharmaceutical-sponsored clinical trials. That experience has included protocols sponsored by organizations such as AbbVie, Astellas, Gilead Sciences, Janssen, Pfizer, Regeneron, and others.
Rheumatology & Autoimmune
Women’s Health
Neurology
Musculoskeletal & Pain
Metabolic Conditions
Infectious Disease
Our operating model is protocol-driven, not indication-limited.
References describe historical research-site support on sponsor-funded studies and do not imply direct sponsor engagement, current affiliation, or endorsement.
Leadership
Director of Enrollment Strategy & Operations
Nicholas Mansilla
Nicholas Mansilla leads Consent2Randomize around a practical question: which parts of finding potential participants and handling the early enrollment work should a research site keep in-house, and where would outside support be useful?
His approach emphasizes clear ownership, consistent follow-up, usable documentation, defined handoffs, and a straightforward point where the research team takes over.
Consent2Randomize gives sites a way to assign agreed recruitment or early enrollment work to an outside team when that is useful, without turning C2R into permanent staffing, software, or a clinical decision-maker.
How We Approach Enrollment Support
Clear Site Oversight
Formal screening, final eligibility, medical decisions, informed consent, protocol oversight, and randomization remain with the qualified research-site team.
Consistent Follow-Through
Referral status, contact attempts, preliminary responses, appointment coordination, and next steps are documented clearly.
Study-Specific Support
The site decides which recruitment or early enrollment activities C2R handles for the study and where the research team takes over.
What C2R Keeps Clear
Within the work C2R handles, the site can see where a candidate stands, what has been completed, what still needs follow-up, what requires escalation, and what is included in the handoff.
Where C2R Fits
A study may use Consent2Randomize to help find potential participants, handle approved early enrollment work after someone expresses interest, or both. When C2R handles post-interest support, that work ends at a clear, documented handoff before the site's formal screening and informed-consent process.
The research team remains responsible for formal screening, final eligibility, informed consent, protocol oversight, medical decisions, and randomization.
The exact C2R scope is established for the study, including whether recruitment, post-interest early enrollment support, or both are included.
See How Consent2Randomize Can Support a Study
Explore the enrollment support model, or bring one active or upcoming study to a brief call and discuss whether recruitment, early enrollment support, or both would be useful.