Clinical Trials(CT)
Are a living ecosystem sponsors, investigators, regulators, IRBs, and, above all, participants moving in sync to turn discovery into dependable evidence. Kernel’s Clinical Trials Integration unifies these parts into one coordinated journey, from first protocol draft to final database lock. We manage the essentials robust informed consent, GCP aligned quality oversight, transparent communications and submissions with FDA/JFDA and IRBs, and audit ready documentation while streamlining multi site collaboration and ensuring participants receive clear information and consistent follow-up. The result: faster, ethically grounded studies that sponsors can trust.
Customized Protocol Design
At Kernel, we don’t just write protocols, we engineer them with precision, care, and a clear roadmap. Following ICH guidelines, our step-by-step methodology sets studies up for success from the first concept through database lock. Whether you’re starting fresh or revising mid-trial, our experts provide on-demand consultation to design, refine, and troubleshoot, ensuring audit-ready rigor, practical feasibility, and seamless execution. Wherever you are in the study journey, we keep your project on track, on time, and on target.
Site Selection
Kernel pairs each study with the right sites using systematic, current, performance-based evaluation, and grows capacity through a dedicated training program for new investigators across therapeutic areas. We collaborate with GPs, specialists, and qualified non-physician investigators to keep studies grounded in real-world practice and elevate delivery.
Patient Recruitment
Our recruitment operations are designed to move quickly without compromising ethics or data integrity. We set targeted eligibility plans, secure IRB approvals, activate multi-channel outreach (EHRs, referrals, patient groups). Enrollment is managed in the EDC with unique IDs, validated screening logs, and real-time accrual dashboards. We use IRB-approved, easy-to-understand consent forms, and our proactive follow-up and retention plans safeguard participant safety while keeping timelines on track.
Documentation & Compliance Management
The regulatory binder is the cornerstone of every successful clinical trial, keeping your study compliant, audit-ready, and organized. At Kernel, we streamline the entire documentation lifecycle, delivering comprehensive, inspection-ready binders that keep your trial on track from start to finish. Our expert team prepares, maintains, and submits all essentials in line with ICH E6 (GCP) Section 8, then navigates approvals with regional and global authorities; streamlining submissions, removing roadblocks, and ensuring flawless records for both single- and multi-site studies.
Shift the research to where patients are.
Decentralized clinical Trails(DCT)
Our DCT model blends in-person care with remote technologies to speed enrollment, reduce buren, and capture higher-quality, real-world data without compromising GCP, privacy, or safety.
Why... Dece ntra lize?
broader reach
higher retention
What We Deliver ??
Hybrid Study Design
We map each procedure to the optimal setting (home, site, telehealth) and define clear escalation rules for safety.
Participant Services
Home health visits, mobile phlebotomy, drug/device logistics, 24/7 helpdesk, and multilingual support.
Digital Platform Stack
eConsent, ePRO/eCOA, telemedicine, eSource, EDC integration, wearables, and BYOD/Provisioned options—validated and 21 CFR Part 11/Annex 11 compliant.
Risk-based monitoring, audit trails, and real-time quality dashboards aligned with ICH E6(R2)/E6(R3) principles.
Submission-ready DCT plans, privacy assessments, and localization for MENA and global authorities (e.g., JFDA/SFDA/DHCR/EMA/FDA)
Direct-to-patient (DtP) and direct-from-patient (DfP) workflows with temperature control, chain-of-custody, and IMP accountability.