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Clinertia

For sponsors

Run your study in Pakistan without giving up oversight.

Placing trials in a new geography usually means trading visibility for access. It should not. Here is exactly how we structure engagements, what you see, and when you see it.

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Why Clinertia

Local fluency, international standard.

  • 01

    Local regulatory fluency

    DRAP and National Bioethics Committee pathways are our home ground. We know which sections attract queries and how to run regulatory and ethics tracks in parallel instead of end to end.

  • 02

    Access to large, treatment-naïve populations

    A population of over 240 million with a high burden of diabetes, hepatitis, cardiovascular disease and tuberculosis — and comparatively low trial saturation — means enrolment targets are met rather than negotiated downward.

  • 03

    Investigators developed to international standard

    Sites are selected and developed against ICH-GCP competency, not just patient volume — because a site that enrols quickly and documents poorly costs more than it delivers.

The case for Pakistan

Where the patients are, trials follow.

High disease burden, a large and young population, and comparatively low trial saturation — the conditions under which enrolment targets are met rather than negotiated down.

Engagement models

Three ways to work together.

Scope the engagement to the gap you actually have. All three run under the same quality system and the same project governance.

  1. 01

    Full service

    We run the study end to end — regulatory, start-up, monitoring, safety, data and reporting — against an agreed scope, timeline and budget.

    When you need in-country delivery without building local infrastructure.

  2. 02

    Functional service

    You retain overall study management; we own one or more functions, working to your SOPs and inside your systems.

    When your gap is a specific capability rather than the whole study.

  3. 03

    Staff placement

    Trained clinical professionals embedded into your team, reporting to your leads, scaling up and down with programme demand.

    For enrolment surges, coverage gaps and building local presence quickly.

Oversight

What you see, and when.

Transparency is a structural commitment, not a reporting cadence we agree to and then quietly relax.

  • A named project manager with decision authority, not a coordinator relaying messages
  • Enrolment and site-performance reporting in a format you specify
  • Direct access to the medical monitor and the regulatory lead
  • A risk register maintained jointly, with agreed escalation thresholds
  • An inspection-ready trial master file, open for review at any point
  • Sponsor audits and co-monitoring welcomed rather than accommodated

Delivery

From first call to close-out.

  1. 01

    Feasibility

    Protocol review, site and country assessment, and an enrolment projection we are prepared to be held to.

  2. 02

    Start-up

    Parallel regulatory, ethics and site contracting tracks, driven against a start-up critical path.

  3. 03

    Conduct

    Risk-based monitoring, active site management, and enrolment reporting you can act on weekly.

  4. 04

    Data & analysis

    Continuous cleaning, coding and reconciliation, then analysis against a pre-agreed statistical plan.

  5. 05

    Close-out

    Site close-out, archiving, final study report contributions and an inspection-ready trial master file.

Services

What you can contract.

Next step

Tell us about your study. We’ll show you how it moves.

Share a synopsis-level summary — indication, phase, target enrolment and timeline. We come back with scope, assumptions and an indicative budget.

Request a proposalcontact@clinertia.com