KCLEAGENICS MEDICAL is a full-service CRO operating across oncology, haematology, and metabolic medicine. We partner with industry sponsors, academic institutions, and specialist clinical centres to deliver rigorous, FDA-compliant clinical research — from protocol design through to publication.
We operate at every stage of the clinical evidence pipeline — providing operational, regulatory, and scientific infrastructure so sponsors can focus on their science.
Phase I–III trial design, site activation and monitoring, investigator support, protocol development, trial master file (TMF) management, and end-to-end GCP-compliant study delivery.
FDA 21 CFR Part 11/50/56 compliance, IND/IDE liaison, IRB and ethics submissions (REC for UK studies), pre-submission meetings, and regulatory correspondence through to approval.
Pre-specified statistical analysis plans (SAPs), data management and cleaning, biostatistical analysis, clinical study reports (CSRs), and academic publication support.
We provide end-to-end biospecimen and tissue collection services for oncology studies — coordinating multi-specialist collection, cold-chain storage, and logistics from site to sponsor or central laboratory.
Our site infrastructure includes dedicated solar-backed power for specimen storage equipment, ensuring uninterrupted cold-chain integrity independent of grid reliability.
Request a Capability Overview →Breast, colorectal, gastric, ovarian, uterine, cervical, and urological tissue. Fresh-frozen, FFPE, and liquid biopsy formats supported.
We coordinate across urology, breast surgery, colorectal surgery, gastric surgery, and gynecologic oncology to support broad-scope collection protocols.
Refrigerated centrifuge, controlled-temperature freezer storage, and solar-backed power supply ensuring specimen viability independent of grid interruptions.
Documented chain-of-custody from collection through shipping, with protocol-aligned handling SOPs, labelling, and manifest documentation for each shipment.
Our operations are structured to meet FDA and international standards — giving sponsors confidence in data quality, regulatory acceptability, and audit readiness.
We operate in accordance with FDA 21 CFR Part 11 (electronic records), Part 50 (informed consent), and Part 56 (IRB requirements) — supporting IND-enabled and FDA-regulated study designs.
All trials are conducted in accordance with ICH Good Clinical Practice E6(R2), ensuring data integrity, subject protection, and audit-ready documentation acceptable to global regulatory authorities.
For multi-site and international studies, we coordinate across academic institutions, specialist oncology centres, and clinical networks — supporting cross-jurisdictional trial designs with unified data standards.
A one-page PDF summary of our CRO services, biospecimen capabilities, regulatory credentials, site specifications, and engagement process — ready to share with your team or sponsor counterpart.
Sponsors evaluating us as a research site can review key site specifications and infrastructure below. Full site qualification packages are available on request.
We are registered with the major US sponsor and site networks used by pharma, biotech, and academic sponsors when selecting research sites.