Built around Nepal's requirements
We plan each study around Nepal's approval path from the first conversation: classifying the study, the Nepal rationale, a Nepalese principal investigator, trial registration, NHRC ethics review and DDA permission.
Clinical trials in Nepal
Advancing global research. Empowering clinical trials in Nepal.
End-to-end clinical research solutions for pharmaceutical and medical device innovators, from study start-up and regulatory submission to clinical operations and close-out.
For sponsors, CROs and research institutions.
Start here
The Nepal regulatory and start-up package
For sponsors and CROs bringing a study to Nepal, we take it from classification to an approved, registered trial that is ready to start. The scope, the people responsible and the timeline are agreed in writing before work begins.
Ask about the start-up package- Study classification and the Nepal rationale
- Support identifying a qualified Nepalese principal investigator and site
- Registration in a WHO-accredited registry
- NHRC ethics submission through IRERP
- DDA permission under the Drug Act
- Site contracts, essential documents and initiation
Why us
Why work with us
Local language and context
Consent forms and participant materials can be translated into Nepali, with back-translation where the ethics committee or sponsor requires it. Working with site staff in their own language supports recruitment, retention and data quality.
One point of contact
One coordinator follows your study from the first brief. Specialists and partners are brought in only where your scope needs them, and every responsibility is agreed in writing before work starts.
Logistics, coordinated
We coordinate investigational product import, cold-chain transport, lab kits and sample shipments with partners agreed for each study, and document the chain of custody from arrival to the site and back.
Services
Feasibility to close-out
In the start-up package
Feasibility and study planning
Country and site feasibility, enrolment estimates, budgets and timelines for Nepal.
In the start-up package
Regulatory and ethics
NHRC and DDA submissions, trial registration, and consent form translation.
In the start-up package
Study start-up
Site contracts, essential documents, GCP training and site initiation.
Planned
Clinical trial logistics
Investigational product import, cold chain, lab kits and sample shipment.
Planned
Clinical operations and monitoring
Project management, on-site and remote monitoring, and site management support.
Planned
Participant recruitment and retention
Recruitment plans based on real site data, with culturally adapted participant materials.
Planned
Safety and pharmacovigilance
SAE reporting to the ethics board and sponsor within required timelines.
Planned
Data, documents and quality
Data management, Trial Master File, audits and inspection readiness.
Planned
Study close-out
Close-out visits, product reconciliation, final reports and archiving.
Study types
Study types we support
Pharmaceutical
Drug trials scoped to what the Nepal pathway allows, from first submission to final report. Early-phase studies carry additional conditions.
Vaccines
Trials with cold-chain logistics and safety follow-up planned in from the start.
Oncology
Studies with careful site selection, complex dosing logistics and close safety oversight.
Medical devices
Clinical investigations, including device import, site training and device accountability.
The Nepal pathway
What a trial in Nepal requires, in order
We handle each of these steps for you.
Summary of NHRC's National Ethical Guidelines for Health Research in Nepal 2022. Confirm current requirements with NHRC and DDA for your study.
Read the full pathway- 1
Classify your study
The pathway depends on design, phase and product. Early-phase and device studies carry additional conditions.
- 2
Build the Nepal rationale
Externally sponsored studies must show why Nepal was chosen, including evidence the research could not be done in the sponsor's country.
- 3
Appoint a Nepalese PI
International collaborations need a Nepalese principal investigator who carries local legal, technical and ethical responsibility.
- 4
Register the trial
Register the trial in a WHO-accredited registry; the registration number goes in with your NHRC ethics submission.
- 5
Obtain NHRC ethics approval
Clinical trials are reviewed by NHRC's Ethical Review Board through its online review platform (IRERP).
- 6
Obtain DDA permission
DDA permission under the Drug Act is required in addition to ethics approval, before the trial starts.
- 7
Start up and report
Serious adverse events go to the Ethical Review Board within 48 hours, with a detailed report within two weeks.
Planning guides
Guides for planning a study in Nepal
Planning a study in Nepal
A step-by-step planning guide to classify the study, identify the review pathway and prepare a coherent submission package.
Read the guideSite feasibility checklist
A practical checklist for evaluating whether a candidate institution can conduct the proposed study, with evidence behind each decision.
Read the guideStudy start-up to close-out
What to plan, document and hand over at each stage of a clinical study, with clear distinctions between operational support and regulatory responsibility.
Read the guidePlease do not send patient information or confidential protocol documents.