Vantrials provides fractional clinical governance to biotech and pharma sponsors running outsourced trials. Senior independent oversight of CRO execution, from study start-up through inspection readiness — scoped to the programme, not a fixed headcount model.
Who We Work With
CROs are skilled at managing their own delivery pipelines. That's not a criticism — it's their business model. The gap is on the sponsor side: without independent senior oversight, the sponsor has no structural check on whether CRO-reported progress reflects what's actually happening at site level.
The Vantrials Difference
Large CROs present their most experienced people at the bid stage. That's standard practice. What matters more is who picks up the programme on day one of delivery, and what accountability structure is in place when things drift.
What We Do
Vantrials doesn't run trials. The role here is to govern the people who do — ensuring that what gets contracted gets delivered, and that sponsors have the senior independent oversight needed to hold CROs accountable across the full programme lifecycle.
Quality Framework
“Vantrials operates under a comprehensive quality management system built to ICH E6(R3) and sponsor-grade standards — the same rigour expected of large CROs, at the engagement scale of a boutique consultancy.”
The quality framework isn't a marketing asset. It exists because regulated sponsors have vendor qualification requirements, and meeting those requirements before a conversation turns into a contract matters. Every engagement is delivered against documented quality standards covering governance, document control, GCP compliance, and TMF management.
The full vendor qualification package, including policy documents, SOPs, and consulting agreement templates, is available on request and typically satisfies sponsor qualification requirements without additional documentation.
Therapeutic Expertise
Operational experience across these areas means familiarity with site profiles, patient population dynamics, and the specific study design and monitoring challenges each therapeutic context presents.
Geographic Reach
Operational experience across 18 countries, with direct engagement across each regulatory environment — not general familiarity with the region, but specific knowledge of how CDSCO, TGA, NMPA, MFDS, HSA, MHRA, and USFDA submissions actually work in practice. All engagements to ICH-GCP E6(R2/R3).
Regulatory frameworks: USFDA · MHRA · TGA · CDSCO · NMPA · MFDS · HSA · All engagements to ICH-GCP E6(R2/R3)
About
Imran Mubashir is a PMP®-certified clinical research professional with over 22 years in study management and global clinical operations. His career spans Phase I through Phase IV and real world evidence across 18 countries in APAC, EU, USA, and Russia, in senior roles with leading global CROs and pharma sponsors since 2003.
The consistent thread across that career has been the sponsor-CRO interface: understanding where well-structured plans break down in execution, and building the oversight structures that catch problems before they become programme-level issues. That operational knowledge is what Vantrials was built to deliver.
Vantrials exists on a straightforward premise: growing biotech companies deserve access to genuinely senior clinical expertise, not contractors filling a headcount gap on paper.
Careers
Vantrials is building a small network of senior clinical research professionals for future engagement opportunities. The profile we're looking for: experienced study managers, GSDs, and CTMs who want the flexibility of consulting but prefer to work within a structured framework rather than managing business development, quality documentation, and client agreements independently.
Associates access engagements sourced through existing Vantrials relationships, with quality infrastructure, agreement templates, and operational support already in place.
Not actively onboarding. We're identifying senior professionals for future collaboration rather than placing immediate roles. If you have GSD or senior study management experience in APAC and are open to exploring what a future engagement might look like, we'd like to hear from you.
Contact
Initial conversations are short and without obligation. If you have a programme in planning or already running, and governance or oversight is a gap, it's worth a 30-minute call to establish whether there's a fit. Most engagements start that way.
Send a Message
All enquiries are handled directly by Imran Mubashir. Responses within one business day.