Phase I to IV Studies - Capabilities

Start-up Capabilities

Study Set-up

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.

Regulatory Submissions

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.

Start-up Capabilities

Site Set-up and Training

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.

Monitoring

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.

Document and Safety Management

Document Management – TMF and ISF

Set-up, maintenance and archival of study specific documents.

Site Level and Client Level.

Safety Management

Intensive AE and SAE oversight and reporting.

Safety letter management.

SUSARs, PSURs and Final Study Report Management.

Data 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.

Quality Management

Study and Site Audits (Internal)

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 / Patient Payment Management

Site payment based on SDV.

Coordination and invoice processing for patient visits.

Operational Management

CRA identification and Training.

CRA authorization visits (when required).

CRA quality assessment visits (when required).