Demo BioNova CRO: clinical research operations day

Demo BioNova CRO runs clinical trials for pharmaceutical sponsors across India, the UAE, Germany, and South Africa. It manages study budgets, investigator sites, enrolled subjects, visits, laboratory shipments, investigator grants, adverse events, milestone invoices, and audit evidence. OSERP connects study project, contract, site, subject, visit, supply inventory, vendor, payment, sponsor billing, and finance.

1. Create the study and approved budget

The study header records protocol number, sponsor, therapeutic area, phase, countries, principal investigator, planned start/end, currency, tax regime, data classification, funding, and status. Budget versions store approval date, assumptions, contingency, country rates, and locked baseline. Lines record site, visit, procedure, subject count, unit rate, pass-through cost, monitoring, laboratory, and account.

Field	Demo value	Impact
Protocol	BN-RA-301	Study and audit key
Phase	III	Control and reporting
Sponsor	Meridian Pharma GmbH	Contract and receivable
Countries	UAE / India / Germany	Tax and FX
Study currency	EUR	Sponsor settlement
Reporting currency	AED	Group reporting
Target subjects	420	Milestones and supplies
Data class	Sensitive health data	Access and retention

A revised budget copies the baseline and records variance. Posted costs never move to a new version without an approved reclassification.

2. Contract sites and investigators

Site records store institution, country, investigator, ethics approval, licence, bank, tax registration, capacity, staff, data-processing agreement, and status. Investigator agreements record study, site, visit rates, pass-through costs, currency, withholding, milestones, publication terms, and approval.

The site activation checklist requires ethics approval, contract, insurance, delegation log, laboratory certification, pharmacy qualification, and training evidence. An inactive or expired site cannot enroll a subject or request new supplies.

3. Enrol subjects and schedule visits

Subject records use pseudonymous ID, site, consent version, screening date, eligibility result, randomisation arm, status, withdrawal reason, and data-retention date. No direct identity is exposed in finance transactions. Visit records store subject, protocol window, planned/actual date, procedure, investigator, visit result, deviation, reimbursement, and source-document status.

At a UAE site, 36 subjects complete Week-12 visits. OSERP calculates the milestone from accepted visits, not scheduled visits, and flags a protocol deviation for review. Subject reimbursements record country, currency, approved amount, receipt, tax treatment, and payment reference.

4. Manage trial supplies and cold chain

Supply items store study, kit number, batch, expiry, storage range, serial, depot, site, quantity, and quarantine status. Shipment headers record source, destination, carrier, temperature logger, package count, customs document, dispatch/receipt time, and status. A temperature excursion quarantines affected kits and opens a quality event.

Inventory issues and returns link kit to subject or visit, quantity, batch, dispenser, pharmacist, and accountability result. Expired or destroyed supplies require reason, witness, certificate, and sponsor approval.

5. Record safety events and monitoring

Adverse-event records store subject pseudonym, event term, severity, seriousness, onset, treatment, outcome, investigator, expedited-report flag, regulator, and evidence. Access is role-limited and every view is audited. Monitoring visits record monitor, site, date, source review, findings, action, due date, and closure evidence.

Corrective-action work orders link finding, owner, deadline, root cause, remediation, verification, and sponsor communication. A critical finding blocks site activity until the approved action is closed.

6. Calculate investigator grants and sponsor billing

Grant schedules store site, milestone, subject/visit basis, rate, currency, tax, withholding, payment terms, bank, and approval. A completed Week-12 visit pays EUR 180 per subject. Sponsor invoices record study, country, milestone, accepted evidence, pass-through cost, currency, tax, due date, and contract line.

For 36 accepted visits at EUR 180, the investigator milestone is EUR 6,480. A sponsor invoice may include monitoring and laboratory pass-through, but each line remains traceable to evidence. A rejected visit remains pending rather than billed.

7. Procure vendors and control study costs

Purchase orders record study, site, vendor, service, country, currency, tax, budget line, safety qualification, delivery date, and approval. Lines contain laboratory, courier, imaging, translation, travel, or data-management service with quantity, rate, milestone, and evidence.

Expense claims store employee, study, visit, country, currency, receipt, tax, patient confidentiality flag, and approval. Advances reconcile to bank return or approved evidence. Three-way matching checks contract, accepted service, and invoice before payment.

8. Multi-currency, retention, and close

The study may contract in EUR, pay sites in INR or AED, and report in AED. Each invoice, grant, receipt, shipment bill, and supplier payment stores transaction rate, source, timestamp, realised FX, and revaluation status. Sponsor receivables, investigator payables, pass-through costs, grants, tax, and deferred revenue remain separate.

Close reconciles protocol milestones to visits, visits to grants, supplies to accountability, vendor invoices to purchase orders, sponsor invoices to accepted evidence, safety events, ethics approvals, data-retention obligations, tax, FX, and GL. Study snapshots retain protocol version, population, approval, and submission evidence.

KPI	Before OSERP discipline	After OSERP discipline	Improvement
Site payment accuracy	92.4%	99.4%	+7 points
Milestone billing lag	26 days	8 days	69% faster
Trial-supply variance	5.8%	1.1%	81% lower
Audit evidence retrieval	13 days	3 days	77% faster
Study close	21 days	7 days	67% faster

Practice challenge

Create a study and budget version, activate a site, enroll pseudonymous subjects, record visits and a protocol deviation, ship temperature-controlled supplies, quarantine an excursion, log an adverse event, calculate investigator grants, invoice an accepted milestone in EUR, pay an INR vendor, revalue balances, and close the study. Explain every field, status, permission, formula, journal, tax result, API identifier, privacy rule, exception, and audit event.

Related: Project and WBS field guide, Purchase Order field guide, Expense Claim field guide, AR Invoice field guide, and API cookbook.