The experience behind the discipline.
ClinicOps is a one-person regulatory data integrity practice, built on work in regulatory consulting, CRO clinical monitoring and pharmacovigilance, and on native Danish regulatory language. The tooling exists to scale that experience, not to replace it.
Who does the work
Ali Iskandar
I'm Danish, based in Spain, working EU-wide in English and Danish. Six-plus years in regulated healthcare documentation across pharmaceuticals, medical devices, IVDs and combination products came first inside CRO and pharmacovigilance organisations, then independently, now through ClinicOps.
Qualifications
I trained at Aalborg University: a Bachelor of Medicine, followed by a Master of Science (MSc) in Medicine (Translational Medicine). A research fellowship in predictive medicine at Complutense University Madrid came along the way, and I'm ICH-GCP trained. Danish is native; English and Spanish are working languages.
Experience, by the work
Pharmacovigilance
ICSR case processing, MedDRA coding and safety-database work (Argus, ArisG, EVWEB/EVDAS) in a specialist PV provider; Danish safety-communication and literature work.
Clinical research and pharma
Phase II–III monitoring and source-data verification at CROs; CTD Module 5 contributions; PSUR, DSUR and RMP structures; product-information and medical-language work for pharmaceutical companies.
Medical devices, IVD and device software
IFUs, labels, eIFU, implant-card and surgical-technique content for international manufacturers, from orthopaedics to digital health; localisation QA of device-software interfaces against the IFU.
Controlled documentation
The full review lifecycle — translation review, post-editing, in-country review, publication proof — within clients’ ISO 13485-governed document control, against the standards the IFU cites (ISO 14971 outputs, EN ISO 20417, ISO 15223-1, IEC 62366-1) and within IEC 62304-governed software lifecycles.
Track record
A regulated documentation practice spanning single-page labels to 60,000-word SS(C)P reviews, including repeat programmes for international device portfolios over consecutive quarters. Client names are used only where disclosure is agreed, so the work is described by segment rather than by name.
What ClinicOps is
One discipline: identify the approved source, define the scope, preserve provenance, compare deterministically, show what is uncertain, route open questions to the accountable owner and keep the closure evidence. The method can be inspected before any engagement: the Regulatory Integrity Scanner, the specimen register and the public research show how it works.
Regulatory data integrity
The core: reconciling approved product information against downstream regulated records after change, delivered as the Regulatory Change Integrity Review.
Data surfaces
EUDAMED and UDI records, certificates, SS(C)P masters and translations, declarations, labels, IFUs and controlled documents.
Language-version integrity
Every maintained language version says what the approved source says, with medically literate Danish↔English review where it is needed.
Denmark & Danish PV
Danish market access and Danish pharmacovigilance support — a secondary route alongside the core discipline.
Automation handles the repeatable steps; professional authority stays with people.
Specialist depth on demand
Where a scope needs clinical context beyond the core review, ClinicOps can introduce independent clinical subject-matter expertise across medicine and nursing. Specialists are chosen for the question, credential-checked per engagement and disclosed before work starts; one accountable owner signs every deliverable. How specialist review works →
What is not claimed
Collaborators are not presented as employees, public-record signals are not presented as findings, and expert opinion is not presented as a regulatory or clinical conclusion. Named professional profiles appear only with consent and verifiable credentials. Project ownership is stated, and every public professional claim traces to retained evidence.