Skip to content
Clinertia

Contract Research Organisation · Karachi

Clinical research,
in motion.

Clinertia runs Phase I–IV clinical trials in Pakistan to international standards — from DRAP submission to database lock — so promising therapies reach patients without losing pace.

Request a proposalExplore services
Phases
I – IV
Service lines
Six, integrated
Approvals
DRAP & NBC

Built around the standards sponsors audit

  • ICH-GCP E6(R3)Good Clinical Practice
  • DRAPDrug Regulatory Authority of Pakistan
  • NBCNational Bioethics Committee
  • 21 CFR Part 11Electronic records & signatures
  • CDISC SDTM / ADaMSubmission data standards
  • MedDRAAdverse event coding
  • WHO-DDMedication coding
  • ICH E2A–E2FSafety reporting

Who we are

One accountable partner, from protocol to database lock.

Clinertia is a Karachi-based Contract Research Organisation. We give pharmaceutical, biotech, device and academic sponsors a single, senior team that owns regulatory approval, site delivery, safety and data — so nothing falls between vendors.

About Clinertia

  1. 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.

  2. 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.

  3. 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.

Services

Six service lines. One quality system.

Contract the full study or a single function. Every line runs under the same governance, so adding a service never adds a hand-off.

All services

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.

How we deliver

From first call to close-out, without stalling.

Five stages, each with named owners and defined outputs. Regulatory and ethics tracks run in parallel, not end to end.

  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.

Therapeutic areas

Broad coverage, deep where it counts.

Pakistan's disease burden is heaviest in exactly the areas where global programmes struggle to enrol — metabolic, hepatic, infectious and cardiovascular disease.

Explore every area

Showing 15 therapeutic areas

  • Oncology
  • Immunology
  • Haematology
  • Endocrinology & Metabolism
  • Cardiology
  • Nephrology
  • Respiratory
  • Gastroenterology & Hepatology
  • Infectious Diseases
  • Vaccines
  • Tuberculosis
  • Neurology
  • Psychiatry
  • Dermatology
  • Ophthalmology

For sponsors

Run your study in Pakistan without giving up oversight.

How we work with sponsors

For sites & investigators

Research built on documentation, not just enrolment.

Join the studies we run

Questions

What sponsors ask first.

Straight answers to the questions that come up on nearly every first call.

Which study phases do you support?

Phase I through Phase IV, including post-marketing and observational studies. Scope can be the full study or a single function such as regulatory submissions, monitoring, pharmacovigilance or data management.

Can you manage DRAP and ethics approvals for us?

Yes. We prepare and submit the clinical trial application to the Drug Regulatory Authority of Pakistan and manage National Bioethics Committee and institutional IRB/EC submissions in parallel, including query responses and import authorisation for investigational product.

We are an international sponsor. How do you keep us in control?

Every engagement has a named project manager with decision authority, reporting in the format you specify, direct access to the medical monitor and regulatory lead, and a trial master file that is inspection-ready at any point. Sponsor audits and co-monitoring are welcome.

Can you work inside our systems and SOPs?

Yes — that is what our functional service and staff placement models are for. Our people work to your SOPs, in your CTMS, EDC and safety database, reporting to your leads.

What do you need from us to prepare a proposal?

A synopsis-level summary is enough to start: indication, phase, target enrolment, anticipated number of sites, timeline and the services you need. We sign an NDA before reviewing a full protocol.

How quickly will we hear back?

We aim to reply to every enquiry within one business day. Proposal requests usually receive a feasibility question or two first, followed by scope, assumptions and an indicative budget.

I run a clinic or hospital department. Can my site join studies?

We are always looking for investigators with access to relevant patient populations and a commitment to documentation quality. Tell us about your specialty, patient volumes and facilities, and we will be straight about fit and any gaps.

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