Why run a study in Pakistan
Pakistan is the world's fifth most populous country and carries a heavy burden of both infectious and chronic disease. Very little of the world's clinical research is done here. For a sponsor, that combination means patients who need better treatments and sites that are not competing for them.
A large population, concentrated in major cities
Tertiary hospitals in Karachi, Lahore, Islamabad, Rawalpindi and Peshawar serve very large catchments, which supports fast enrolment at a small number of sites.
Source: Pakistan Bureau of Statistics, 7th Population and Housing Census 2023 and Digital Census Key Findings Report, 2024.
Where the need is greatest
An under-used research base
A 2024 review found 2,723 studies from Pakistan on the WHO trial registry between 2000 and 2022. Universities sponsored most of them, and pharmaceutical companies about 9 per cent. Internationally, fewer than 5 per cent of trials have been run in 91 low and lower-middle income countries combined. Industry-sponsored research in Pakistan has room to grow.
Source: Mumtaz H, et al. Clinical trials landscape in a lower-middle-income country (Pakistan). Journal of Clinical and Translational Science, 2024.
A defined regulatory pathway
Clinical research in Pakistan is regulated by the Drug Regulatory Authority of Pakistan under the Bio-Study Rules 2017. Pakistan adopted ICH Good Clinical Practice as its standard in 2002.
Institutional ethics committee
The ethics committee at every study site reviews the protocol, the consent documents and the investigator. Reviews at different sites can run in parallel.
What we do. We prepare each site’s submission, answer queries and track approvals site by site.
National Bioethics Committee
National ethics approval is required before DRAP will consider a clinical study application, under Rule 9 of the Bio-Study Rules 2017.
What we do. We compile the national submission and manage correspondence until approval.
DRAP Clinical Studies Committee
The Clinical Studies Committee of the Drug Regulatory Authority of Pakistan reviews the application. It meets about every 45 days, so the filing date decides which meeting considers the study.
What we do. We plan the filing around the committee calendar so the application is complete in time for the next meeting.
Authorisation and import licence
DRAP authorises the study. Where investigational product is imported, an import licence is also required.
What we do. We apply for the import licence in parallel so supplies are ready when authorisation arrives.
Study start
The study begins at clinical trial sites licensed by DRAP, after site initiation and training.
What we do. We run the site initiation visits and activate the study systems.
The Clinical Studies Committee meets about every 45 days. Contract research organisations and clinical trial sites must each hold a DRAP licence, which gives sponsors a regulator-verified baseline for whoever they work with.
Source: Drug Regulatory Authority of Pakistan, Clinical Trials Oversight.
Pakistan is not the right country for every study
We would rather you knew the constraints at the start.
Approval time
Reviews are sequential in part and depend on committee calendars. We build a realistic timeline before you commit.
Site experience
Experience of industry-sponsored trials varies between sites. We select sites on evidence and train them before the study starts.
Import logistics
Importing investigational product and exporting samples both need licences. We manage the applications.
Language
Consent documents must be available in Urdu, and often in regional languages. We prepare them in Urdu and in regional languages as needed.
What a local partner does
We are your licensed presence in the country. We hold the relationships with DRAP, ethics committees and sites, we monitor in person, and we answer to you in your time zone and in your reporting format.