✔ Consultation on protocol design in the operational perspective.
✔ Upfront discussion on risks and challenges expected and recommendation / implementation of CAPA.
✔ Creation of study-specific documents, worksheets and tools for use by the site and study team.
✔ Recommendation and Identification of facility(ies) or site(s) for healthy volunteers or a specific patient population.
✔ Site Feasibility and collection of essential documents.
✔ Consultation of suitable countries based on regulatory framework and timelines.
✔ Planning Regulatory / Ethics Committee / IRB submissions based on the timelines.
✔ IND submissions, preparation of summary of product characterisation (SmPC), Import/Export Licenses.
✔ Preparation of documents for submission.
✔ Coordinating for query resolution towards securing timely approval.
✔ Study document amendment management.
✔ Site Initiation.
✔ Study-specific document distribution.
✔ Training of site and study team on protocol and study activities.
✔ Essential document management.
✔ Document amendments and its management.
✔ Overseeing trial progress.
✔ Forecasting site visits for completing source verification.
✔ Site document management.
✔ Site training.
✔ Early detection of risk factors and implementation of CAPA.
✔ Detailed tracking and reporting of trial activities.
✔ Set-up, maintenance and archival of study specific documents.
✔ Site Level and Client Level.
✔ Intensive AE and SAE oversight and reporting.
✔ Safety letter management.
✔ SUSARs, PSURs and Final Study Report Management.
✔ Set-up of database and planning.
✔ Deployment and Training.
✔ Database maintenance and query resolution.
✔ Periodic safety analysis and data extraction for interim analysis.
✔ Database Cleaning and Lock.
✔ Dedicated team to perform periodic checks and formal audits, both study and site level.
✔ Implementation of corrective actions for the findings.
✔ Preparation for inspection readiness.
✔ Site payment based on SDV.
✔ Coordination and invoice processing for patient visits.
✔ CRA identification and Training.
✔ CRA authorization visits (when required).
✔ CRA quality assessment visits (when required).