Services

Decision-Led Advisory for Clinical Technology Markets

Each engagement is built around the solution, decision, or adoption challenge in front of you, not a rigid product menu. We clarify the problem, define the scope, and work toward outcomes that can survive real clinical, technical, and commercial constraints.

01. AI Readiness 02. Use Case Prioritization 03. Operating Model 04. Platform, Vendor 05. Executive Advisory

Start With Your Context

Different Seats. Shared Clinical Development Stakes.

The work is scoped around your decision, but the starting point is usually one of two stakeholder contexts.

Clinical Technology Companies

For vendors that need stronger product direction, sharper market understanding, clearer positioning, or executive-level advisory grounded in how clinical development buyers actually decide.

Product strategy
Market and customer insight
Competitive positioning
GTM strategy
Thought leadership and executive advisory

Pharma & Biotech Leaders

For sponsors making technology, AI, data, vendor, or operating-model decisions where the goal is practical clinical development improvement, not another disconnected initiative.

AI readiness and adoption
Clinical technology strategy
Vendor assessment and selection
Operating model and process transformation
Implementation and adoption planning

AI Readiness & Adoption Assessment

Relevant for

Pharma & Biotech Leaders

The Problem

Organizations invest in AI, clinical platforms, and data modernization without a clear picture of where they stand today, leading to misaligned capital, wasted effort, and initiatives that stall before they deliver.

What I Deliver

Current-state capability and maturity assessment
Clinical context readiness map across systems, governed content, workflow rules, and decision rights
Gap analysis across people, process, and technology dimensions
eClinical and AI readiness scorecard
Prioritized opportunity map with supporting rationale
Executive briefing with clear, actionable findings

Expected Outcomes

A clear, honest view of where your organization stands—what is working, where the gaps are, and which opportunities are genuinely worth pursuing.

Want a structured starting point? Take the 5-minute Clinical AI Maturity Assessment for a focused snapshot.

Start the assessment

Use Case Prioritization & Roadmapping

Relevant for

Pharma & Biotech LeadersClinical Technology Companies

The Problem

Leadership teams are overwhelmed by competing priorities, vendor pitches, and internal demands. The hardest question is rarely "what technology could we use?" It is "which use cases should we pursue first, and why?" Get this wrong and budget gets spent on initiatives that never reach production—and roadmaps lose executive support within a quarter.

What I Deliver

Prioritized eClinical and AI roadmap with sequencing rationale
Business case frameworks for high-priority initiatives
Context extractability assessment for each priority use case
Resource and dependency mapping
Executive alignment materials and facilitation
Decision criteria and governance recommendations

Expected Outcomes

Aligned leadership, a defensible sequencing of initiatives, and a clear basis for resource allocation decisions that holds up under scrutiny.

Operating Model & Deployment Planning

Relevant for

Pharma & Biotech Leaders

The Problem

Technology strategy without execution design fails. Most organizations can describe where they want to go; far fewer have the governance, ownership, validation, and change model required to deploy new systems successfully.

What I Deliver

Future-state operating model design
Governance framework and decision rights mapping
Reusable context asset plan covering workflow maps, evidence requirements, evaluation cases, and validation assumptions
Change readiness and stakeholder analysis
Deployment planning playbook with milestones and metrics
Risk and dependency register

Expected Outcomes

An execution-ready plan with clear ownership, governance structure, and measurable milestones—built to survive contact with organizational reality.

Platform, Vendor & Partner Advisory

Relevant for

Pharma & Biotech LeadersClinical Technology Companies

The Problem

Sponsors face a crowded technology landscape. Clinical technology vendors face an equally crowded market. eClinical, data, and AI decisions often blur together, making it difficult to determine what to buy, what to build, where to partner, how to position, and how to avoid locking in the wrong operating model or product direction.

What I Deliver

Current and future-state technology landscape review
Vendor and platform evaluation criteria
Build-buy-partner decision framework
Product and market-positioning implications of major platform decisions
Selection support and stakeholder alignment materials
Implementation risk assessment and mitigation plan
Operating model implications of major platform decisions

Expected Outcomes

Clearer technology decisions, better vendor fit, stronger product-market alignment, and a more realistic path from selection, positioning, or partnership to adoption and measurable value.

Executive Advisory & Program Strategy Support

Relevant for

Pharma & Biotech LeadersClinical Technology Companies

The Problem

Senior executives navigating clinical, data, AI, or commercial transformation often lack objective, experienced counsel at the intersection of clinical development, operating model, product reality, data, and technology. Decisions get made in isolation, second-guessed in board reviews, and reversed when the gap shows up in delivery or market adoption.

What I Deliver

Ongoing strategic advisory and decision support
Initiative and portfolio review
eClinical, AI, vendor, product, and partner evaluation support
Market, customer, and competitive insight for clinical technology decisions
Board and leadership team preparation
On-demand access for critical decisions

Expected Outcomes

Faster, more confident decisions. An objective sounding board with deep domain experience. Senior counsel without the overhead of a large consulting engagement.

Case Studies

Selected Engagements

Three deep engagements illustrate how this work shows up in practice — across pharma, biotech, and CRO. All clients are anonymized.

Clinical Architecture for a Scaling Pipeline

Client

Mid-cap oncology biotech, later acquired by a top-10 pharma.

The Challenge

A high-growth oncology biotech approaching a scaling inflection point. Multiple eClinical systems had been adopted tactically as the company grew, leaving overlapping capabilities, manual handoffs, and no shared framework between business and IT for prioritizing clinical technology investments. With pipeline expansion accelerating, the existing operating model was not going to scale.

Approach

A 10-week capabilities-centric clinical architecture assessment. Four phases: confirm strategy and goals, assess current-state capabilities, processes, and systems, define future-state capability map and conceptual architecture aligned to anticipated growth, and build a prioritized 24-month roadmap.

What Was Delivered

Strategy-on-a-Page document aligning business and IT leadership
Current-state inventory: capabilities, systems, data flows, process pain points
Future-state capability map and conceptual application architecture
Capability gap assessment with prioritization
Prioritized 24-month clinical IT roadmap, including study start-up modernization, vendor governance, integrated CTMS, and operational data warehouse
Recommended adjustments to in-flight projects

Outcome

Leadership gained a defensible, capabilities-grounded view of where the clinical technology stack stood and where it needed to go — and a prioritized 24-month roadmap they could fund and sequence against, including study start-up modernization, vendor governance, an integrated CTMS, and an operational data warehouse. (The company was later acquired by a top-10 pharma in a multi-billion-dollar transaction; the architecture work predated and was independent of that deal.)

Chris’s Role

Executive Sponsor and senior advisor — hands-on across all phases of the engagement (strategy workshops, current-state assessment, future-state design, roadmap). Led the Clinical Optimization practice and the team that delivered the work.

Clinical Data Strategy and Program Leadership

Client

Global plasma therapeutics company, top-5 in category.

The Challenge

A flagship clinical study was launching alongside a major data platform implementation. Leadership needed two things at once: tactical execution of the platform program tied to the flagship study, and a longer-term clinical data strategy defining where in the data lifecycle to inject standards (CDASH, SDTM) and how to demonstrate ROI on standards investments. Without alignment between the two, the immediate program risked getting built on a foundation the long-term strategy would later have to undo.

Approach

Eight-month engagement combining program leadership for the platform implementation with parallel definition and refinement of the broader clinical data strategy. Four phases: assessment (current-state pain points and industry trends), program leadership (governance, plan, cross-functional coordination), future-state design (process maps, business + vendor RACI, information and solution architectures), and roadmap (initiative prioritization, ROI-mapped sequencing).

What Was Delivered

Program governance structure and execution plan, aligned to the broader data strategy
Future-state process maps for clinical data management
Sponsor + vendor RACI across business capabilities
Future-state information and solution architectures
Initiative prioritization matrix (automated SDTM provisioning, data governance, RBM dashboards, investigator portal, MDM, eTMF, CDASH libraries)
Multi-year process and technology roadmap

Outcome

The long-term clinical data strategy was defined and adopted. The team continued through implementation of the SCE (Statistical Computing Environment) platform supporting the flagship study and the broader portfolio — moving the strategy from definition to operational capability.

Chris’s Role

Executive Sponsor and senior advisor on the engagement. Hands-on across the eight months — assessment interviews, governance design, future-state workshops, capability and process mapping, prioritization, and roadmap shaping. Led the Clinical Optimization practice and the team that delivered the work.

Clinical Architecture for Sponsor Competitiveness

Client

Specialized mid-cap CRO with deep CNS and cardiovascular expertise.

The Challenge

The CRO had built its eClinical stack tactically — point solutions adopted as needs arose. The result was meaningful capability gaps (no formal study start-up system, no risk-based monitoring, no eConsent, no ePRO) and no shared framework with sponsors for evaluating where to invest next. CRO competitiveness depends on technology fluency, especially on enterprise sponsor RFPs; the architecture needed strategic shape, not another tactical fix.

Approach

Six-week clinical architecture assessment. Four phases: strategy identification (business drivers and outcomes), capability identification (industry-aligned capability map tailored to the CRO operating model), current-state evaluation (system-to-capability mapping, gap identification), and future-state and roadmap (target architecture and sequenced initiatives).

What Was Delivered

Strategy-on-a-Page for the CRO's clinical operations
Client-specific clinical capability map
Current-state application architecture and system-to-capability mapping
Capability gap analysis (RBM, study start-up, eConsent, ePRO, others)
Future-state conceptual architecture
Prioritized roadmap of system deployments and process initiatives

Outcome

The roadmap shaped the CRO's next-year clinical technology budget and capital priorities. Prioritized initiatives were funded and implemented, closing key capability gaps and delivering measurable value to clinical operations.

Chris’s Role

Executive Sponsor and senior advisor. Hands-on across all phases — strategy definition, capability mapping, current-state evaluation, future-state design, and roadmap. Led the Clinical Optimization practice that originated the offering and delivered the engagement.

Engagement Formats

Most engagements begin with a focused discovery conversation to clarify the problem, scope the work, and confirm fit.

4–8 weeks

Strategic Assessment

6–16 weeks

Project-Based Engagement

Monthly, ongoing

Advisory Retainer

1–3 days

Executive Workshop

Not Sure Which Service Fits?

Start with a conversation. I will help you identify the right scope and approach for your specific situation—no pitch, no pressure.

Scope a discovery call