Independent clinical research advisory

Strong foundations. Faster study start-up.

Practical strategy and hands-on execution for clinical development teams navigating feasibility, site activation, operational complexity, and change.

Founder & Principal Consultant

Experienced leadership. Practical execution.

Gennie Jackson Blank founded Cornerstone Clinical Strategies to help clinical development teams translate complex start-up challenges into clear decisions and executable plans.

With approximately 25 years in clinical research, Gennie brings experience working across global pharmaceutical sponsors and contract research organizations, including leadership roles spanning study start-up, site activation, feasibility, contracts and budgets, and cross-functional delivery.

Her work emphasizes operational transformation: establishing decision rights, improving oversight, aligning stakeholders, resolving escalations, and building repeatable ways of working that support predictable execution.

Cornerstone combines senior-level strategic perspective with hands-on problem solving—especially when teams need focused expertise without adding permanent leadership capacity.

Areas of expertise

Global study start-up and site activation leadership
Feasibility and country/site strategy
Clinical operations transformation
Contracts, budgets, and complex escalations
CRO oversight and governance
Training and leadership development

Signature consulting packages

Targeted expertise for critical delivery needs.

Each engagement is scoped to the organization's objectives, urgency, and operating environment. Deliverables below are illustrative and finalized in a statement of work.

01

SSU Rescue & Recovery

Rapid assessment and hands-on recovery support for delayed or at-risk study start-up.

Potential deliverables: bottleneck assessment, prioritized recovery plan, escalation map, milestone dashboard, governance cadence.

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02

Fractional Clinical Operations Leadership

Interim or part-time leadership for sponsors and teams needing senior operational direction.

Potential deliverables: leadership coverage, team coaching, portfolio priorities, risk reviews, decision and accountability structure.

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03

Global Feasibility & Site Strategy

Evidence-informed country and site strategies aligned to protocol demands and activation realities.

Potential deliverables: feasibility framework, country/site assessment, assumptions and risks, site engagement strategy.

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04

Clinical Operations Transformation

Improve processes, interfaces, and operating models without losing focus on delivery.

Potential deliverables: current-state review, future-state operating model, RACI, KPIs, change and implementation roadmap.

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05

CRO Oversight & Governance

Strengthen sponsor–CRO collaboration, transparency, accountability, and escalation effectiveness.

Potential deliverables: oversight framework, performance review rhythm, issue logs, escalation pathways, corrective-action tracking.

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06

Training & Leadership Development

Practical facilitation and capability building for clinical operations, study teams, and leaders.

Potential deliverables: workshops, train-the-trainer sessions, bid defense facilitation, scenario-based exercises, learning assessments.

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How we work

Strategy that translates into action.

01ASSESS

Understand the constraint

Clarify the objective, review the current state, and identify the decisions or bottlenecks that matter.

02ALIGN

Build a workable plan

Establish priorities, ownership, milestones, and a governance rhythm that teams can sustain.

03EXECUTE

Deliver measurable progress

Support implementation, resolve issues early, and adjust based on evidence and results.

Engagement options

Flexible by design.

From a targeted assessment or project-based engagement to ongoing fractional leadership, support can be tailored to your stage of development, team structure, and delivery priorities.

Typical partners include emerging biotech companies, established sponsors, CROs, and clinical research teams seeking specialized start-up expertise.

Business development

Let's discuss your priorities.

Share a high-level description of your challenge and preferred next step. Please do not submit patient data, protected health information, confidential protocols, or proprietary study documents.

Book an introductory consultation

A scheduling link can be activated once your preferred booking service and calendar are confirmed.

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Client perspectives

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