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Clinertia

About Clinertia

Built so good studies keep moving.

We are a Contract Research Organisation based in Karachi, delivering clinical trials in Pakistan for pharmaceutical, biotech, device and academic sponsors — to the standards those sponsors are inspected against.

clin·er·tia

Why “Clinertia”

Clinical, and inertia — the tendency of a body in motion to stay in motion.

Most trials lose their momentum in the same places: a regulatory query nobody saw coming, a site that enrols fast and documents slowly, a data cut that surfaces problems weeks too late. We are built around those failure points, so a study that starts well keeps moving.

Vision

To be the clinical research partner sponsors trust to run studies in Pakistan — and the reason more global trials include patients from this region at all.

Mission

To deliver clinical trials that meet international standards of quality and data integrity, while widening access to investigational treatment for patients across Pakistan.

Values

The rules we operate to.

Not aspirations on a wall — the working principles that decide what happens when a timeline, a budget and a patient's interests pull in different directions.

  • 01

    Quality

    ICH-GCP is the floor, not the target. Processes are written to survive an inspection on any given day, not to be prepared for one.

  • 02

    Integrity

    Data is reported as observed. Timelines are quoted as achievable. Where a study is not feasible, we say so before the contract, not after.

  • 03

    Patient focus

    Participants carry the risk in every trial. Consent is genuinely informed, burden is minimised, and safety questions are answered by a physician, quickly.

  • 04

    Partnership

    Sponsors get a named team with real decision authority, not a rotating contact list and a monthly status deck.

  • 05

    Responsiveness

    Sites and sponsors both operate on clocks. Queries, escalations and approvals move on defined turnaround times.

  • 06

    Accountability

    When something slips, it is surfaced early with a plan attached. Problems get smaller when they are visible.

Standards

Built to be inspected.

Our processes, systems and deliverables are designed around the regulatory and data standards that sponsors, regulators and ethics committees audit against.

  • ICH-GCP E6(R3)

    Good Clinical Practice

  • DRAP

    Drug Regulatory Authority of Pakistan

  • NBC

    National Bioethics Committee

  • 21 CFR Part 11

    Electronic records & signatures

  • CDISC SDTM / ADaM

    Submission data standards

  • MedDRA

    Adverse event coding

  • WHO-DD

    Medication coding

  • ICH E2A–E2F

    Safety reporting

How we deliver

Five stages. Named owners.

  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.

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.