ImpactIQ: Biotech PMO, Clinical Operations & Fractional Consulting
Biotech PMO and fractional clinical operations consulting for IND and IDE programs, Smartsheet implementation, vendor governance, and execution infrastructure for complex clinical portfolios.
Our Approach
At ImpactIQ, we believe clinical programs don’t fail on science, they fail on execution.
We partner with clinical-stage and platform biotech companies developing small molecules, biologics, cell and gene therapies, diagnostics, medical devices, and combination products. Whether navigating the IND or IDE pathway, our focus remains the same: building the execution infrastructure and embedded expertise required to protect timelines and reduce operational risk.
Our work begins with a deep understanding of your study portfolio, vendor landscape, development stage, and cross-functional complexity.
From there, we implement the right combination of:
• PMO and workflow systems that make milestones, risk, and vendor performance visible
• Fractional clinical experts across clinical operations, contracts, data management, medical writing, regulatory, quality, and inspection readiness
• Governance structures that align scope, budget, and execution across active studies
Whether preparing for IND submission, activating multi-site clinical trials, transitioning phases, or managing inspection readiness, our approach is designed to increase clarity, strengthen accountability, and support confident leadership decision-making.
PMO & Workflow Infrastructure
We design and implement fit-for-purpose PMO systems and Smartsheet-based workflows that provide:
• Program & portfolio visibility
• Study-level milestone tracking
• Inspection readiness dashboards
• Vendor performance oversight
• Resource and timeline governance
Two Ways We Strengthen Clinical Execution
ImpactIQ combines infrastructure and embedded expertise to support IND and IDE programs at every stage of development.
Fractional Biotech Expertise
We provide experienced consultants across:
• Clinical Operations
• Contracts & Vendor Governance
• Data Management
• Medical Writing
• Project & Program Management
• Regulatory Affairs
• Quality Assurance
Engagement models include embedded leadership, milestone-based support, and retainer-based oversight.
Diagnostics & Device (IDE Pathway)
We support companies operating under the IDE pathway, including:
• In vitro diagnostics
• Medical devices
• Combination products
• Platform-based technologies
Across:
• Study startup coordination
• Multi-site oversight
• Contract governance
• Cross-functional milestone alignment
Our focus: structured execution across complex, multi-study environments.
Biotech (IND Pathway)
We support companies developing:
• Small molecules
• Biologics
• Cell and gene therapies
• Platform-based therapeutics
Across:
• Pre-IND strategy
• Phase transitions
• NDA/BLA preparation
• Inspection readiness
Our focus: execution infrastructure, vendor governance, and milestone visibility.
Industries We Support
ImpactIQ partners with clinical-stage companies across therapeutic modalities and regulatory pathways, strengthening execution from early development through late-stage programs.
When Clients Call Us
ImpactIQ is often brought in when execution risk becomes visible or when leadership wants clarity before it does.
Clients typically reach out when:
• Multiple studies are running and visibility across teams is fragmented
• Vendor oversight feels reactive instead of structured
• Contract volume and change orders are increasing without governance or tracking
• Teams are debating whether to hire or augment expertise
• Phase transitions are approaching (IND, IDE, pivotal trials)
• Inspection readiness feels closer than it should
• Timelines exist, but confidence in them does not
ImpactIQ was founded by Athena Dhari, a senior clinical program management leader with extensive experience supporting clinical-stage biotech organizations across therapeutic modalities and development phases.
Throughout her career, Athena has partnered with executive teams and leaders across clinical development, clinical operations, program management, research, non-clinical, manufacturing, commercial operations, regulatory affairs, and quality assurance to strengthen execution infrastructure, improve vendor governance, and increase milestone confidence in complex development environments.
Today, she leads ImpactIQ’s consulting platform — combining structured PMO systems with embedded fractional expertise to support IND and IDE programs at critical inflection points.
Founded by Clinical Program Leadership Experience
Experience Snapshot
ImpactIQ has supported clinical-stage and platform biotechnology organizations across diverse therapeutic areas and development stages.
Our experience includes:
• Clinical programs spanning Pre-IND through Phase 3 and IDE activation
• Small molecules, biologics, regenerative medicine, diagnostics, and device programs
• Multi-study portfolios requiring structured PMO and vendor governance
• Cross-functional environments integrating Clinical, CMC, Commercial, Data Management, Medical Affairs, Non-Clinical, Program & Project Management, Regulatory, Research, and QA.
• Organizations preparing for regulatory inspection and board-level reporting
We partner with leadership teams at critical operational inflection points to restore clarity, strengthen governance, and protect milestones.