Fractional Global Study Director
End-to-end protocol governance for Phase I–IV trials. CRO selection, oversight, and performance management. Study start-up through close-out and CSR sign-off.
Associate Director-level clinical governance at fractional commitment. From Phase I first-in-human to Phase IV post-marketing — across biotech, pharma, and medical device programmes.
What We Do
Vantrials sits precisely in that gap — providing the senior oversight layer that small-to-mid biotech and specialist CROs cannot sustain in-house at full-time cost.
We embed as your Fractional Global Study Director or Programme Lead, speaking both sponsor and CRO fluently, holding execution accountable without replacing your team.
The result: tighter timelines, cleaner data, and a governance record that withstands regulatory scrutiny.
Services
Six practice areas, each providing Associate Director-level expertise at fractional commitment.
End-to-end protocol governance for Phase I–IV trials. CRO selection, oversight, and performance management. Study start-up through close-out and CSR sign-off.
Structured oversight above your CRO delivery layer. KRI-based monitoring, escalation management, JOC facilitation, and CAPA tracking to SLA resolution.
Multi-country study management across 18 APAC countries. Site activation, country timelines, regulatory submissions, and regional vendor coordination.
Pre-inspection TMF audit, quality gap assessment, and remediation planning for USFDA, MHRA, and TGA inspections. Inspection support as needed.
Site feasibility, selection, and activation for complex multi-country trials. Protocol optimisation, site readiness, and first patient in acceleration planning.
Clinical investigation planning and oversight under ISO 14155. CE-mark and CDSCO IDM experience. CIP development, site qualification, and eSRC/ethics management.
Therapeutic Expertise
Deep operational experience across oncology, metabolic disease, cardiovascular, and rare disease programmes globally.
Regulatory Experience
Active regulatory submission and inspection experience across the major agencies governing clinical trials in APAC, Americas, and Europe.
Quality Framework
Every Vantrials engagement operates under a structured quality framework aligned to ICH E6 R3 and sponsor SOPs.
Systematic protocol review, deviation tracking, and amendment management — with accountability to the sponsor's quality register throughout the study lifecycle.
RBQM-aligned monitoring plans, KRI thresholds, and centralised data review integrated with your CTMS and EDC infrastructure.
Trial Master File governance from study start-up through archival. Completeness tracking, milestone-based audits, and inspection-ready documentation at all times.
Structured KPI/KRI frameworks, escalation protocols, JOC facilitation, and CAPA management — ensuring your CRO delivers against contracted milestones.
Who We Work With
Series A–C biotechs running Phase I/II programmes without a full clinical operations team. We act as your embedded study director, managing CRO performance and regulatory submissions end-to-end.
CROs seeking senior clinical expertise above their delivery layer — for complex sponsors, multi-regional programmes, or accounts where governance depth is a competitive requirement. Refer to our CRO Partner page.
Device companies planning clinical investigations under ISO 14155 for CE-mark or CDSCO IDM submissions — needing a study director with both regulatory and operational depth.
Engagement Models
Each model is designed for a different bandwidth need — from a single study to a long-term governance partnership.
Geographic Reach
Deep operational experience across APAC, with active regulatory knowledge spanning Americas, Europe, and MEA.
Principal Consultant
Imran Mubashir is a clinical research professional with 22 years of experience across Phase I–IV trials in 18 APAC countries, operating at Associate Director level across both sponsor-side and CRO-side environments.
His career spans Abbott Laboratories, Bristol Myers Squibb, Parexel International, PRA Health Sciences, Emerald Clinical Research, and BioPlus Life Sciences — across oncology, hepatology/MASH, cardiovascular, metabolic disease, infectious disease, immunology, and rare disease.
He founded Vantrials to provide the governance layer that emerging biotech and specialist CROs need most: senior clinical leadership, without the full-time overhead.
Credentials & Background
Most engagements begin with a 30-minute scoping call. No commitment required.
Email Imran directly CRO Partner enquiries →