Advancing Clinical Research Worldwide
Yoshe Clinical Operations — a hybrid CRO and SMO registered in England & Wales and the United States — delivers full-lifecycle clinical trial management with embedded quality systems, inspection-ready teams, and global regulatory expertise.
A New Standard for Clinical Excellence
Yoshe Clinical Operations was founded to address the growing need for efficient, reliable clinical trial management for pharma, biotech, and medical device manufacturers worldwide. We combine CRO depth with SMO agility — delivering high-quality, timely, and cost-effective solutions tailored to every client's unique needs.
Our Mission
To deliver comprehensive, inspection-ready clinical trial management from first-in-human to post-marketing, supporting sponsors from Phase I through Phase IV with embedded quality and compliance.
Our Vision
To be the most trusted hybrid CRO-SMO for emerging and mid-sized biopharmaceutical companies seeking global reach with UK and EU sites as their regulatory gateway.
Our Values
Quality without compromise. Regulatory precision. Innovation in every process. Transparency with clients, sites, and participants at every stage.
Our UK entity serves as the European and MHRA regulatory hub — managing clinical research sites across NHS Trusts, primary care networks, and dedicated research units across England, Scotland, Wales, and the EU. Operating under post-Brexit MHRA pathways and EU CTR 536/2014 through dual-jurisdiction compliance.
organisation.
Two entities.
Our US entity enables full FDA IND pathway management, connecting North American sponsors with UK and EU sites. As a registered Medidata CRO Partner, we leverage Rave EDC, CTMS, eTMF, and eCOA technology infrastructure to run compliant, data-driven studies across APAC, North America, Europe, and Australia.
Revolutionising Clinical Research Through Innovation
We envision a world where breakthrough therapies reach patients faster. Yoshe exists to remove the friction between scientific discovery and regulatory approval — providing the infrastructure, expertise, and quality systems that sites and sponsors need to execute exceptional clinical trials.
Delivering Quality, Speed & Compliance at Every Stage
To provide high-quality, timely, and cost-effective clinical trial management solutions tailored to each client's unique needs. From site activation and QMS design to study close-out and inspection readiness — we are with you at every step of the clinical development journey.
Building the Global Standard for Site-Level Excellence
Expand the Yoshe site network across UK, EU, North America, APAC, and Australia. Develop Yoshe Clinical Academy into a globally recognised GCP training provider. Achieve Medidata Elite Partner status. Establish Yoshe as the benchmark hybrid CRO-SMO for emerging biopharma sponsors.
Full-Lifecycle Clinical Services
From first-in-human Phase I studies through Phase IV post-marketing trials, our integrated service model covers every function required for compliant, high-quality clinical research.
End-to-end Phase I–IV clinical trial management with full sponsor liaison, protocol oversight, and medical monitoring coordination.
- Phase I–IV management
- Protocol design support
- Medical monitoring
- Adaptive trial design
Full-function QMS deployment — 120+ SOPs across 12 categories, CAPA, audits, deviation management, and inspection readiness.
- 120+ SOP suite
- RBQM framework
- Internal audit programme
- Inspection readiness
Comprehensive site activation, management, and close-out across UK NHS Trusts, EU research centres, and global site networks.
- Site feasibility & activation
- CTA/REC submissions
- Ongoing site oversight
- Study close-out
Strategic regulatory submissions and intelligence across MHRA, EMA/CTIS, and US FDA — from IND/CTA to end-of-trial notifications.
- MHRA CTA applications
- EU CTIS submissions
- FDA IND management
- Safety reporting
Medidata Rave EDC, CTMS, eTMF, eCOA, and LMS — fully validated clinical technology ecosystems aligned with 21 CFR Part 11 and ALCOA+.
- Medidata Rave EDC
- eTMF / eISF
- CTMS oversight
- Data governance
ICH E3-compliant CSRs, protocols, investigator brochures, regulatory submissions, and scientific publications for global filings.
- Clinical Study Reports
- Protocol authoring
- Regulatory documents
- Strategic consulting
Aligned with Global Regulatory Authorities
Every Yoshe process, SOP, and deliverable is built for multi-jurisdictional compliance — so your sites are always inspection-ready across all applicable regulatory frameworks.
Operating Across Four Continents
As a Medidata-registered CRO partner with presence in the UK, USA, EU, APAC, and Australia, Yoshe connects sponsors to inspection-ready research sites anywhere in the world.
I–IV
Deep Scientific Expertise Across Therapeutic Areas
Our team brings specialised knowledge across 13 therapeutic domains — ensuring protocol feasibility, site selection, and patient recruitment strategies are grounded in real-world clinical understanding.
ICH E6(R3)-aligned GCP training for site staff, investigators, and sponsor personnel. Available as blended LMS + classroom.
Comprehensive CRA training covering source data verification, monitoring visits, RBQM, and regulatory submissions.
Multi-jurisdictional regulatory training covering EMA, FDA, MHRA, EU CTR, ICH guidelines, and post-Brexit pathways.
Site-level professional competency programme for clinical research coordinators covering consent, data entry, and IP management.
Hands-on training in Rave EDC, CTMS, eTMF, and eCOA — delivered in alignment with 21 CFR Part 11 validation requirements.
Building the Next Generation of Clinical Research Professionals
The Yoshe Clinical Academy delivers ICH E6(R3)-aligned training programmes through our LMS-powered blended learning platform — equipping every team member with the knowledge and competencies required for inspection-ready clinical research.
Flexible online courses with automated competency tracking and digital certification.
Rigorous assessment frameworks aligned with GCP delegation requirements.
Audit-trail training records maintained in compliance with ICH E6(R3) 2.8.
MHRA, EMA, and FDA curriculum tracks adapted for each regulatory jurisdiction.
Our Compliance Commitments
Every engagement with Yoshe is underpinned by a robust compliance architecture — from data governance and ethics to quality assurance and inspection readiness.
Full GDPR and UK GDPR compliance. DPIA for every study. Data Processing Agreements with all sponsors. EU-US Data Privacy Framework adherent.
- DPIA completed per study
- 72-hour breach notification
- Cross-border transfer compliance
- Subject access request management
Risk-based quality management aligned with ICH E6(R3) Section 5. Annual internal audit programme. CAPA system with root cause analysis.
- RBQM framework
- Annual audit programme
- KPI and quality metrics reporting
- Deviation management system
ICH E6(R3) 4.8-aligned informed consent processes. Vulnerability protection. IRB/REC oversight for all studies. Patient diversity and inclusion commitment.
- IRB/REC approved consent
- eConsent capability
- Diversity inclusion programme
- Patient rights framework
Full transparency with MHRA, EMA, and FDA. Annual progress reports submitted on schedule. Serious adverse event reporting within mandatory timelines.
- SUSAR within 7/15 days
- Annual progress reports
- Protocol amendment notifications
- End-of-trial notifications
All computerised systems validated per 21 CFR Part 11 and EMA Annex 11. GAMP5 principles applied. Full audit trail integrity for all electronic records.
- 21 CFR Part 11 compliant
- GAMP5 validation
- ALCOA+ data integrity
- Electronic audit trails
15-year archive obligations maintained per EU CTR, MHRA, and FDA requirements. Secure eTMF and eISF archiving. Results disclosed on CTIS and ClinicalTrials.gov.
- 15-year retention policy
- eTMF final QC review
- CTIS results disclosure
- ClinicalTrials.gov registration
Yoshe Clinical Operations LLC is a registered partner on the Medidata CRO Partner Programme. Our studies run on Medidata Rave EDC, CTMS, eTMF, and eCOA — providing sponsors with industry-leading data quality, real-time oversight, and seamless regulatory submission-ready data packages.
Partner with Yoshe Clinical
Whether you are a sponsor seeking a compliant CRO partner, a research site exploring SMO support, or a professional interested in our Academy — we'd like to hear from you.
Registered in England & Wales
Medidata CRO Partner