Ten Pillars of Our CTM Framework
Every clinical project is supported by a bespoke operational team, robust SOPs, and integrated data visibility.
e-Feasibility Studies
Algorithm-driven site identification, patient prevalence modeling, and realistic recruitment commitment forecasts.
Phase I–IV Execution
Seamless execution across all trial phases, including healthy volunteer PK studies, proof-of-concept, and pivotal Phase III trials.
Data Safety Management
Proactive pharmacovigilance, real-time adverse event processing, and DSMB / IDMC charter execution.
Dedicated Operations Team
Assigned Senior Project Managers and seasoned CRAs with deep local regulatory knowledge and investigator relationships.
Audit & Inspection Readiness
Continuous mock audit drills, TMF completeness checks, and regulatory inspection preparation.
GRAVITY Document Engine
Direct integration with our DIA TMF Reference Model e-TMF and investigator site file repository.
Detailed Operational Lifecycle
Explore our systematic approach across each stage of clinical trial conduct.
- Consultation on protocol design from an operational and regulatory perspective.
- Upfront discussion on anticipated protocol challenges and preventive CAPA strategies.
- Creation of study-specific worksheets, investigator toolkits, and monitoring manuals.
- Rapid collection of essential documents and Ethics Committee / IRB submissions.
- Advisory on optimal country and site selection based on regulatory speed and disease burden.
- Preparation and review of Clinical Trial Applications (CTA / IND).
- Direct liaising with Competent Authorities (MHRA, EMA, FDA, CDSCO, etc.).
- Combination of centralized risk-based monitoring and comprehensive on-site SDV.
- Real-time issue escalation and protocol deviation management.
- Investigational Medicinal Product (IMP) tracking and temperature log verification.
- Final site close-out visits and drug reconciliation/destruction certification.
- TMF final reconciliation and audit-ready digital handover.
- Regulatory notifications of trial completion and CSR development support.
Ready to Evaluate Your Study Feasibility?
Contact our clinical operations experts today for protocol feasibility review and timeline benchmarking.