Services
- Site selection
- Full study set-up, including: investigator identification, selection and recruitment
- Performing feasibility study.
- Start up
- Managing regulatory authority applications and approvals – EC/IRB/MoH submissions.
- Collecting and handling essential documents (EDpack).
- Handling CTA & budgets with legal departments and commercial committees.
- Handling translations (coordinating & translating).
- Setting up the study centers which includes ensuring each centre has the trial materials.
- Training site staff to trial specific and industry standards (GCP).
- Performing investigator meetings – contents, logistic & administration.
- Site Management / Clinical
- Global project management.
- Study site management.
- Protocol, operating manual and CRF development.
- Ethics committee (EC, IRB, MoH) submission and management.
- Investigator grant negotiation and administration.
- Initiating the sites and briefing study team/investigators on conducting the trial.
- Clinical monitoring from pre-study visits through to study close-out Preparation for sponsor’s/authorities audit.
- Ongoing medical review of all CRFs/Monitoring the trial throughout its duration, which will involve visiting the study centers on a regular basis; source data/document verification (SDV). writing visit reports.
- Regulatory Affairs – Our regulatory experts possess an astounding wealth of knowledge, enabling us to offer quality regulatory and clinical development services.
- Close-Out
- Performing close out visits, ensuring all unused trial supplies are accounted for closing down study centers on completion of the trial.
- Archiving study documentation and correspondence.
- Preparing final reports and occasionally manuscripts for publication.
