From first filing to final report
- DRAP clinical study applications. We compile and file the application to the Clinical Studies Committee of the Drug Regulatory Authority of Pakistan.
- National Bioethics Committee. We obtain the national ethics approval that DRAP requires before it considers an application.
- Institutional ethics committees. We prepare and track submissions to the review board at each study site.
- Amendments. We submit protocol and document amendments and keep approvals current.
- Periodic and final reporting. We file progress reports, safety reports and end-of-study notifications.
Five steps to authorisation
Institutional and national ethics reviews can run in parallel. The Clinical Studies Committee meets at intervals through the year, so the filing date matters. We plan submissions around the committee calendar.
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.
We have been through DRAP’s process ourselves
Regulatory submissions are led by Dr Abeera Aslam, Regulatory Affairs and Project Manager.
InnovexHealth CRO Pvt Ltd was inspected and licensed under the Bio-Study Rules 2017, and our team includes professionals who have managed regulatory affairs for multinational pharmaceutical companies in Pakistan.