Clinical Operations
Study-ready sites, every time
Deploy protocol-specific training, SOPs and investigator packs to dozens of sites — tracked, attested and audit-ready.
KOŚA for CROs & Clinical Research
One platform. Every protocol. Every site.Sponsor-ready, inspection-ready, always.
Stop stitching together paper, email and legacy eTMF systems. KOŚA runs every study on a single, audit-ready platform — so monitors, sponsors and regulators get what they need, when they need it.
Why CROs choose KOŚA
Built for the complexity of modern clinical trials.
Multi-site, multi-protocol, multi-sponsor — one platform that keeps every study aligned, every site trained, and every audit closed without findings.
Quality & Regulatory
Sponsor audits on demand
Generate per-study, per-site audit reports in minutes — no manual reconciliation across paper, email and spreadsheets.
Data Management
ALCOA++ from protocol to database lock
Every training record, deviation and amendment signed, timestamped and immutable — from first patient visit to final CSR.
48 hours
New study setup from template
95%+
Site training completion on first visit
Multi-site
One platform, dozens of sites, zero drift
100%
Sponsor-ready audit packs on demand
Multi-site by design
One CRO. Many studies. Dozens of sites. Zero drift.
Every study gets its own scoped workspace — SOPs, training curricula, deviations and site files — while your central team maintains oversight across the portfolio.
Global site deployment
Push protocol amendments and training to 50+ sites in under an hour.
Study-scoped workspaces
Each study is isolated — no risk of cross-study data leakage.
Sponsor audit packs
Generate per-study, per-site eTMF and training reports in minutes.
Template-driven study setup
Clone a proven study template — documents, training and workflows — in 48 hours.
Study portfolio on KOŚA
Oncology Study 301
12 sites
- Protocol & amendments
- Site training matrix
- Deviations & CAPAs
- Audit trail
Cardiology Study 204
8 sites
- Protocol & amendments
- Site training matrix
- Deviations & CAPAs
- Audit trail
Rare Disease Study 105
24 sites
- Protocol & amendments
- Site training matrix
- Deviations & CAPAs
- Audit trail
Central oversight team · single sign-onZero cross-study access
Connected modules
See all 13 modules →Every module, study-aware.
Start with study document management and site training. Layer in QMS, eTMF, LIMS and site management as your portfolio grows — on one audit-ready stack.
Study Document Management
Protocol, ICF, IB and amendment control with versioned distribution to sites — and read-receipts that satisfy monitors.
Site Training & LMS
Protocol-specific curricula, investigator training and OJT attestation — per site, per role, per study.
Study QMS
Deviations, CAPAs and change control scoped to each study — with cross-site KPIs for sponsor oversight.
eTMF & Investigator Site Files
Electronic trial master file and ISF management with e-signatures, watermarked copies and TMF reference model alignment.
Lab & Bioanalytical LIMS
Sample tracking, kit management and bioanalytical data — from central lab to site-level collection.
Investigator Site Management
Site qualification, training matrix, supply chain and monitoring visit documentation in one place.
Outcomes
What changes for your CRO the day you go live.
KOŚA replaces fragmented paper, email and legacy eTMF systems with one validated platform — designed by compliance architects who’ve passed sponsor and regulator audits.
48-hour study setup
New study workspace — documents, training and site files — live in under two days from a proven template.
Compliance by design
Sponsor-ready. Regulator-ready. Every study.
Every action signed, timestamped and immutable — per study. Every release backed by a validated change control trail your sponsors can audit anytime.
21 CFR Part 11
EU Annex 11
ALCOA++
GAMP 5
ICH GCP E6(R2)
WHO Data Integrity
"We cut our study setup time from three weeks to two days. Sponsor audits that used to take a month of preparation now happen in real time — they just log in and see everything."
Head of Clinical Operations, mid-size APAC CRO
See KOŚA running your study portfolio.
45-minute demo with a compliance architect — bring a real protocol, we’ll show you the study workspace in action.