Clinical research services
InnovexHealth CRO Pvt Ltd provides clinical research services under a licence issued by the Drug Regulatory Authority of Pakistan. You can hand us a complete study, or engage one function to work alongside your own team.
Four phases, three milestones, one controlled process
Every step is documented, carried out by trained staff and checked by our quality assurance function.
Pre-study planning
- Protocol development and review
- Feasibility assessment
- Site identification, qualification and selection
- CRF and informed consent development
- Regulatory and ethics submission (DRAP, ethics committees)
- Data management plan and eCRF build in EDC
Study start-up
- Site initiation visit and training
- Systems activation: EDC and randomisation
- Trial master file activation
- Study supplies and investigational product release
Study conduct
- Recruitment and screening
- Clinical monitoring and source data verification
- Data entry, query management and coding
- Safety and pharmacovigilance (AE and SAE)
- Protocol deviation management
Close-out and reporting
- Site close-out visit
- Safety follow-up and SAE reconciliation
- Database lock
- Statistical analysis to the SAP
- Final clinical study report
- Trial master file finalisation and archiving for 15 years
Continuous functions that run across every phase of the study.
- Quality management and CAPA
- Document management and TMF
- Training and GCP competency
- Regulatory affairs
- Facility, IT and system validation
Interim analyses, where planned, are conducted during study conduct under the data safety monitoring board charter. Safety reporting continues through to database lock. Aligned to ICH E6 Good Clinical Practice and DRAP guidelines for clinical research.
Clinical research services
Clinical Operations
Site selection, study start-up, monitoring and close-out for Phase III and Phase IV studies. Conducted to ICH Good Clinical Practice.
IVD Clinical Performance Studies
Performance studies for in vitro diagnostics, designed to ISO 20916.
Regulatory Submissions
Applications to DRAP, the National Bioethics Committee and institutional ethics committees.
Medical Writing
Protocols, consent forms, investigator's brochures and study reports.
Data Management & Biostatistics
Electronic data capture on OpenClinica, with analysis to a pre-agreed statistical plan.
Full service or a single function
Under a full-service engagement we take responsibility for the study from feasibility to final report, with one project manager as your point of contact.
Under a functional engagement we supply one service, such as monitoring or medical writing, and work to your procedures or ours as you prefer.
Advisory services
We also advise importers and manufacturers on medical device registration and market entry in Pakistan. This is consultancy work, offered separately from our licensed clinical research services.