The experience behind the discipline.
ClinicOps is founded and run by Ali Iskandar — MSc in Medicine (Translational Medicine), Aalborg University — with a professional background across regulatory consulting, CRO clinical monitoring and pharmacovigilance, more than 500 regulated documentation assignments delivered, and native Danish regulatory-language capability. The tooling exists to scale that experience, not to replace it.
Founder
Ali Iskandar — Founder, ClinicOps
Danish, based in Spain, working EU-wide in English and Danish. 6+ years supporting regulated healthcare documentation across pharmaceuticals, medical devices, IVDs and combination products — first inside CRO and pharmacovigilance organisations, then as an independent documentation-quality specialist, now through ClinicOps as a regulatory data integrity practice.
Qualifications
MSc in Medicine (Translational Medicine), Aalborg University (2020–2022, industrial specialisation: drug development, medical-device development, QA, medical legislation, statistics) · Bachelor of Medicine, Aalborg University · Research Fellow in predictive medicine, Complutense University Madrid (industry collaboration) · ICH-GCP trained · Native Danish, professional English and Spanish.
Experience, organised by the work
Pharmacovigilance
Hands-on pharmacovigilance experience in a specialist PV provider setting: ICSR case processing, MedDRA coding and safety-database work (Argus, ArisG, EVWEB/EVDAS), plus Danish safety-communication and literature-relevant language work. GVP-framework familiarity from operational practice.
Pharma
Clinical-trial and safety documentation in pharmaceutical settings: Phase II–III monitoring documentation, source-data verification records, CTD Module 5 contributions, and familiarity with PSUR, DSUR and RMP structures — alongside controlled product-information and medical-language work for global pharmaceutical companies.
Medical devices / IVD / device software
Hands-on work with controlled medical-device documentation — IFUs, labels, eIFU content, implant-card and surgical-technique material — for international manufacturers across orthopaedic, surgical-instrument, wound-care and respiratory, cardiac-monitoring, dental/orthodontic, aesthetic and digital-health portfolios, including localisation QA of regulated device-software user-interface content checked for consistency with the IFU.
Technical & controlled documentation
Full review lifecycle on regulated documents — translation review, post-editing, finalisation, back-edit, in-country review and publication-level proof — delivered within clients' ISO 13485-governed document-control processes, with IFU and labelling reviewed against ISO 14971 risk-communication outputs, EN ISO 20417, ISO 15223-1 and IEC 62366-1, and documentation and verification records within IEC 62304-governed software lifecycles.
Selected experience
More than 500 regulated documentation assignments delivered — from single-page labels to 60,000+-word SS(C)P reviews — with a 100% on-time record, including repeat regulated-documentation programmes for international medical-device portfolios over consecutive quarters and a 100% quality score across every completed labelling and marketing localization job in the most recent production batch. Client names from this work are used only where disclosure is agreed; on this site the work is presented by segment rather than by name, deliberately.
What ClinicOps is
ClinicOps is an evidence-controlled regulatory data integrity practice with one discipline: identify the authoritative or approved source, define scope, preserve provenance, compare deterministically, expose uncertainty, route unresolved questions to the accountable owner and retain closure evidence. That method is inspectable before any engagement — the Regulatory Integrity Scanner, the specimen register and the public research show exactly 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
The same approved fact held consistent across every maintained language version, with medically literate Danish↔English review as the deepest capability.
Denmark & Danish PV
Danish market access and Danish pharmacovigilance support — a secondary, demand-evidenced route alongside the core discipline.
Automation supports stable evidence-handling steps. It does not inherit reserved professional authority.
Specialist depth on demand
ClinicOps combines Ali Iskandar’s medical, pharmacovigilance, Pharma and MedTech documentation experience with access to independent clinical subject-matter expertise across medicine and nursing, introduced when a scope requires deeper clinical context. Specialists are selected for the specific question, credential-checked per engagement and disclosed to the client before work starts; the engagement lead remains the single accountable owner of every deliverable. How specialist review works →
Authenticity over inflated authority
ClinicOps does not present every collaborator as an employee, every public-record signal as a finding, or every expert opinion as a regulatory or clinical conclusion. Named professional profiles are used only with consent and verifiable credentials. Project ownership is stated explicitly, and every public professional claim traces to retained evidence.