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IRT Providers

Focus: Helping providers improve product strategy, operations, and market competitiveness.

Product Strategy & Feature Development – Advise on market-driven enhancements to meet sponsor expectations and compliance demands in a dynamic industry.

Operational Excellence & Scalability – Build or refine project management frameworks, implement change management strategies.

Sponsor Advocacy & Relationship Management – Design client advisory boards, coach teams on strategic account management.

Sales & Business Development Support – Review and optimize RFI responses, provide objection handling, leverage network for new introductions.

Audit & Compliance Program Development – Create frameworks for GxP compliance, 21 CFR Part 11, GDPR, and ICH E6(R3) adherence.

Sponsors

Focus: Helping sponsors select, implement, and optimize IRT solutions while improving vendor relationships, compliance, and operational efficiency.

IRT Strategy & Roadmap Development – Advise on how your organization can approach IRT at the study or enterprise level.

Vendor Selection & Governance – Lead RFI/RFP processes, negotiate MSAs and SLAs, implement KPI dashboards and governance structures.

System Implementation & Validation Oversight – Define user requirements, oversee vendor-led configuration (development as needed) and validation, Provide UAT guidance and if needed contract outside firm.

Process Development & Optimization – Reengineer supply chain–IRT interfaces, develop SOPs for IRT management, audit trails, and data ownership.

Inspection Readiness & Compliance – Prepare for regulatory inspections, conduct mock audits focused on data integrity, audit trails, and governance.

Investors

Focus: Helping investors evaluate and grow businesses in the IRT and clinical trial services sector.

Due Diligence Support – Evaluate target company capabilities, compliance risk, and product offering.

Market Assessment – Provide market intelligence on IRT trends, competitive landscape, and pricing benchmarks.

Post-Acquisition Growth Strategy – Develop integration and expansion plans for acquired companies; identify partnership opportunities.

Operational Risk Assessment – Identify bottlenecks, quality risks, and governance gaps; recommend remediation priorities.