Feasibility and site selection
Before a study is committed, we test whether it can be done. We assess the patient population, identify hospitals and investigators with the right case mix, and visit each candidate site to check staff, facilities and ethics committee arrangements.
You receive a written feasibility report with a recommended site list and a realistic enrolment forecast.
Study start-up
We prepare the submission package, obtain ethics committee and National Bioethics Committee approval, and file the clinical study application with DRAP. In parallel we negotiate site agreements, set up the investigator site file and train site staff on the protocol.
Monitoring and site management
Our clinical research associates monitor each site against a monitoring plan agreed with you. They verify informed consent, check source data against case report forms, confirm that the investigational product is stored and accounted for, and follow up every protocol deviation to closure.
You receive a monitoring report after each visit.
Safety reporting
We collect, assess and report adverse events within the timelines DRAP and the ethics committees require. Serious adverse events are reviewed by our Medical Director.
Close-out and archiving
At the end of the study we reconcile investigational product, resolve outstanding queries, close each site and archive the trial master file in our access-controlled archive.
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.
How the work is governed
- ICH E6 Good Clinical Practice
- ISO 14155 for clinical investigations of medical devices
- Bio-Study Rules 2017 (Pakistan)