Skip to content

CTMS for clinical study protocols, enrollment and visit data capture

Serhiy
Employer

Serhiy

> 10 projects
Project parameters
Type of cooperationOne-time project
Prepaymentwithout prepayment
Payment methodsCash, Bank transfer
Acceptance of requestsfrom until Sep 21, 2026
Project description
We run clinical studies and currently track everything on paper: participant lists in binders, visit schedules on printed calendars, and case report forms filled in by hand at each site. This no longer scales. We need a clinical trial management system that holds our study protocols and participating sites in one place, and lets coordinators enroll participants, check them against eligibility criteria, and follow each person through the full visit schedule without losing a page.

The core of the work is turning our paper flow into structured data. Each protocol defines its own visit windows, procedures and forms, so the system must let us configure the schedule of assessments per study and then generate the expected visits for every enrolled participant automatically. Coordinators should open a participant, see which visit is due, record the visit outcome, and complete the electronic case report forms tied to that visit. We also need adverse-event logging that captures onset, severity, outcome and relatedness, kept separate from routine visit data but linked to the participant.

Reporting is the final piece. Study leads need enrollment progress against target, upcoming and overdue visits per site, missing or incomplete forms, and an adverse-event overview, all exportable for our sponsors and monitors. Access must be role-based so a site coordinator sees only their site while the study manager sees everything.

— Protocol and site setup, per-study schedule of assessments
— Enrollment with eligibility screening and participant records
— Visit generation, scheduling and electronic case report forms
— Adverse-event logging and progress reporting with exports
Project author: Serhiy