Project Management Services
Structured oversight to ensure compliant, efficient, and transparent clinical trial execution.
Our Project Management Capabilities : Our disciplined yet flexible approach enables efficient study conduct, proactive risk management, and audit-ready documentation.
Project Management services are integral throughout the entire conduct of the study, beginning with pre-study planning, continuing through active study execution, and extending into post-study closeout activities.
We provide structured, end-to-end oversight across the entire study lifecycle. From pre-study planning and regulatory coordination to data oversight, quality assurance, and final closeout. By serving as the central point of coordination among sponsors, investigators, and cross-functional teams, we ensure clear communication, regulatory compliance, timely execution, and robust data integrity.
Study Planning and Start-Up
- Preparation of project milestone plan and deliverable tracking
- Feasibility assessment of participating centers
- Site identification, selection, and onboarding
- Oversight of Ethics Committee (EC) submissions and timelines
- Finalization of draft CTAs at all participating institutions
Regulatory and Compliance Management
- Ensure NDCT Rules 2019 / ICH-GCP compliance (as applicable)
- Assistance with CTRI registration and related regulatory requirements
Project Coordination and Communication
- Central liaison among sponsor, investigators, data-collection teams, and statisticians
- Establishment of structured communication and reporting pathways
- Monthly/weekly project status meetings and progress reporting
Data Management Oversight
- Setup and oversight of data collection tools
- Monitoring accuracy and completeness of submitted data
Quality Assurance and Monitoring
- Development of monitoring plan aligned with study design
- Identification, initiation and follow-up of CAPAs
Budget and Financial Oversight
- Budget planning and tracker development
- Processing of invoices from sites/vendors
- Oversight of TDS/GST compliance and documentation
Biostatistics and Medical Writing Coordination
- Coordination with biostatisticians teams for analysis plan (SAP)
- Transfer of cleaned and locked datasets
- Coordination for manuscript writing (if applicable)
- Support for poster/abstract presentations (if applicable)
Study Close-Out
- Confirmation of data completion across all sites
- Completion of site compliance checklists
- Preparation of final project closure reports
Documentation and Archival
- Archival of study documentation in compliance with regulatory requirements (typically 5 years)
- Secure data storage to ensure audit readiness
- Handover of final dataset, logs, and documentation to sponsors
