For CROs, Sponsors, Site Networks, and SMOs
Consent2Randomize provides defined Clinical Trial Enrollment Support for selected research sites, whether the site contracts directly or a CRO or sponsor coordinates the engagement. Depending on the study, support may include patient recruitment, post-interest enrollment operations, or both.
The research site retains clinical interpretation, formal screening, eligibility decisions, informed consent, protocol oversight, investigator responsibility, medical decisions, and randomization decisions.
Either model can support a defined site-level workload. The appropriate structure depends on who is coordinating the work, which sites are included, and how approvals, access, reporting, escalation, and handoffs are organized.
The research site contracts directly with Consent2Randomize and defines the operational support it wants to assign.
A CRO or sponsor contracts with Consent2Randomize to provide defined operational support to selected research sites.
These conditions can prompt a site, CRO, sponsor, network, or SMO to review its support model. They do not mean outsourcing is required in every situation.
Recruitment activity creates inquiries or referrals, but selected sites cannot address each record through a consistent early follow-up process.
Contact attempts, candidate statuses, referral sources, or next actions are recorded differently across locations.
Staff leave, study startup, or competing active studies create a defined gap in administrative enrollment coverage.
Early follow-up responsibilities are not assigned clearly, or coordinator handoffs arrive without consistent context.
A CRO, sponsor, or site leader needs agreed activity, candidate-status, or referral-source visibility without introducing another software platform.
A site network or SMO wants a shared operational structure that still preserves approved site- and study-specific requirements.
When the need is a temporary workload gap at participating sites, review coordinator capacity support.
Not every engagement includes every activity. The agreement identifies the selected work and the site-approved procedures that govern it. For the primary recurring execution service, review hands-on intake and preliminary prescreening support.
Before support begins, the parties document how the work will operate at the participating sites. These decisions create a practical working structure without changing responsibilities reserved to the research site.
For repeatable ownership, status, documentation, and measurement standards across studies or locations, review clinical trial enrollment infrastructure.
Reporting can be configured around the activities, statuses, recipients, and review cadence defined for the engagement.
Referral received
First documented action
Contact attempts
Current candidate status
Preliminary intake completion
Escalation status
Site handoff status
Scheduling status where applicable
Referral-source identification
Unresolved operational items
Reporting supports visibility, workload review, and discussion of unresolved operational items. It does not prove why enrollment performance changed or predict study results.
See real-world enrollment operations scenarios for examples of documented intake, follow-up, scheduling, and handoff challenges.
These services can be complementary. Exact responsibilities vary by provider and agreement, and Consent2Randomize does not replace the other parties supporting a study.
Creates awareness, inquiries, or referrals through the activities included in the recruitment scope.
Provides a site-led or CRO- or sponsor-led structure for defined early enrollment operations at selected sites.
May include broader study management, monitoring, or operational responsibilities under the CRO contract.
Provides personnel for defined positions, assignments, or coverage periods.
Provides technology for tracking, communication, documentation, or workflow management.
Assesses the current process and designs workflow, ownership, documentation, measurement, and implementation improvements.
Executes the agreed post-referral operational activities within approved site processes.
For the broader operating category, review clinical trial enrollment operations.
For assessment and process design, explore enrollment operations consulting.
Common questions about site-led and CRO- or sponsor-led enrollment support.
Use a brief scoping conversation to discuss who would contract, the included sites and studies, operational scope, workflow approval, authorized access, documentation, escalation, reporting, and handoff expectations.
Prefer a written introduction? Contact Consent2Randomize to discuss the proposed engagement structure.
