Clinical trials in Pakistan are authorised by DRAP under the Bio-Study Rules, with a Clinical Studies Committee, local ethics review and a licensed site. Capture is a self-serve EDC that research teams can build and test free.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Pakistan
Key points for studies in Pakistan
Regulation
The Bio-Study Rules, 2017, were notified under the DRAP Act and amended later, for example by SRO 685(I)/2023 for bioavailability and bioequivalence forms. DRAP describes authorisation by Form-V and Form-VI, and says no one may conduct a clinical trial of a drug without the required certificate. The Clinical Studies Committee reviews and approves protocols for ethical and scientific adequacy. The guidelines are updated, and DRAP's regulatory updates page lists the current edition, so start there and not with a vendor summary.
Ethics review is local. Teaching hospitals and universities in Karachi, Lahore, Islamabad and Rawalpindi have institutional review boards, and national-level bioethics bodies exist. Which ones review a specific study, and in what order, depends on the site and the product, so ask the research office. Our guide to how to get IRB approval lists the documents ethics boards usually expect, and Capture's blank eCRF PDF (cover page, form index, visit-by-form matrix, every approved form empty) goes straight into that pack.
A foreign sponsor will generally need a local route for submissions. The rules refer to CROs, and secondary sources say a local entity is commonly used. Capture is not that entity. It is a platform your sponsor, investigator or appointed CRO configures and runs.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
Inspection readiness
Regulators in any country start from the same questions: who entered this value, who changed it, when and why. Capture writes a field-level audit trail with timestamp, user, old value, new value and reason for change, and each repeating row (such as concomitant medications) has its own trail. The trail cannot be edited through the interface, and exports include it. Edit checks raise an auto-query when a value breaks a rule, so discrepancies are documented as they happen.
Weight changed 68.0 to 68.5 kg
Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
Enter sample data in the free sandbox, change a value with a reason and export the trail to see what an inspector would see.
Approvals
| Layer | Body | What to prepare | Where Capture helps |
|---|---|---|---|
| Trial authorisation | DRAP, via the Clinical Studies Committee | Protocol, product data, investigator details, forms per the guidelines | Blank eCRF PDF; documented edit checks. |
| Site licence | CSC, per secondary summary | Site facilities and staff documents | Site accounts and delegation by role. |
| Ethics | Institutional review board; NBC where applicable | Consent form, participant information, protocol | Consent template and signed PDF. |
| Sponsor or CRO | Local CRO or representative | Agreements, insurance, pharmacovigilance plan | Safety forms, AE listings, by-site exports. |
| Registry | Registry per journal or sponsor policy | Registration number | Protocol fields reused for registration. |
Layers summarise DRAP pages and secondary sources. Confirm each with DRAP and the site.
Data protection
Pakistan has debated a Personal Data Protection Bill for several years, and our search did not return a current enacted text for trial data. State that uncertainty openly to your ethics board and treat the participant protections as a design requirement irrespective of statute. Tell participants plainly where data is stored, that Capture processes it in Frankfurt or N. Virginia, and who can see names.
In Capture, site coordinators see participant names while researchers see coded IDs, enforced by row-level security. Data is encrypted with AES-256 at rest and TLS in transit. If your sponsor also applies GDPR or HIPAA standards as a contractual baseline, see GDPR compliant clinical trial software and HIPAA vs GDPR clinical trial data.
Site coordinator
Jane Peterson
DOB: 04-Mar-1978
Subject 01-004
Sees direct identifiersResearcher
Subject 01-004
DOB: withheld
Coded ID only
Sees coded ID onlySame record, two roles. Row-level security enforces the split.
Research landscape
A large share of Pakistani research is investigator-led work at medical universities and teaching hospitals, plus bioequivalence work for local manufacturers and multinational studies in infectious disease, diabetes, cardiovascular and maternal health. Budgets are tight, and teams often wrestle with spreadsheets or paper CRFs. With no setup fee and a free sandbox, Capture suits EDC for investigator-initiated trials and EDC for academic clinical trials.
Connectivity can vary between sites. Offline entry is not claimed for Capture, so plan data entry around reliable connections. For a comparable regime in the region see India and Indonesia.
Typical start-up
A planning sketch, not a regulatory timeline.
Use the 3rd edition and the Bio-Study Rules as your checklist.
Decide who files with DRAP: sponsor entity, CRO or investigator.
Draft visits and forms, test them with site staff, export the blank eCRF PDF.
IRB and any national review; confirm the site licence with the CSC.
Create site accounts, enrol participants and monitor queries.
DRAP, under the Bio-Study Rules 2017 made under the DRAP Act 2012. Its Clinical Studies Committee reviews protocols, and ethics review happens at institutional level. Check the current guidelines on dra.gov.pk.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). If your study needs in-country hosting, ask counsel and do not assume Capture fits.
We could not confirm a current enacted statute from our research. Ask local counsel, and treat participant privacy as a design requirement either way.
No. Capture is self-serve, with no office, partner or CRO in Pakistan.
No. DRAP authorises trials, not EDC software. Capture provides an audit trail, e-signatures and role-based access, and your validated use is what is assessed.
You can build and test forms for many study types in the sandbox. Check with DRAP what its bioequivalence guidance expects from the data system before you rely on any tool.
Yes. The free sandbox has every feature, with no credit card and no time limit. You pay only at go-live.
Keep exploring
Clinical trial software in Indonesia
BPOM and the PDP Law.
Clinical trial software in India
CDSCO and ethics committees.
Clinical trial software in Saudi Arabia
SFDA route.
EDC for investigator-initiated trials
For small academic teams.
How to get IRB approval
What the ethics pack contains.
Features
The full platform.
Build forms, export the blank eCRF PDF and test the audit trail free. Pay only at go-live.