Scott Kelly Consulting

What Scott Kelly Consulting does

Scott Kelly Consulting is a founder-operated, boutique clinical research consultancy headquartered in Durham, North Carolina. The practice is led by Scott Kelly as Founder and Principal Consultant and provides professional services to pharmaceutical and biotechnology companies for drug development programs. Specifically, the firm delivers clinical program direction, budget and contract development, multi-party partnership management, and mentoring of junior clinical staff — a service mix narrowly built around the founder's direct experience at Takeda and Genentech as evidenced by named on-site testimonials. Documented outcomes include serving as Clinical Program Director for Takeda's pediatric IBD clinical study that achieved FDA pediatric indication approval for Lialda, and acting as Clinical Program Director for Genentech on a rare-indication, early-phase trial that required operational coordination across an industry sponsor, a global academic expert consortium, and a CRO.

The firm's underlying technology profile is people-based rather than platform-based: no software product, API, SDK, proprietary technology stack, patents, or AI tooling is disclosed. The core deliverable is senior-level advisory and operational leadership applied to complex clinical programs — particularly those involving pediatric recruitment difficulties, rare disease drug development, and multi-stakeholder partnership coordination. There is no app, no SaaS offering, and no third-party integrations documented.

The business model is straightforward professional services: quote-based engagements scoped by duration and complexity, with pricing not publicly disclosed. There is a single revenue stream — "Clinical Research Consulting Services" — categorized as professional_services. Go-to-market is sales-led and direct: a website contact form that lets leads self-identify as Sponsor/Biotech, CRO/ARO, academic, hospital, independent consultant, or recruitment professional, supplemented by a LinkedIn-based professional network. The firm uses no intermediaries or channel partners and serves only the United States. Ownership is founder-only, bootstrapped, with no external investors, no parent company, and no subsidiaries. The listed headcount range of 11–50 is inconsistent with documented solo operations and most plausibly reflects contracted/sub-contractor capacity rather than W-2 employees.

Name

Scott Kelly Consulting

Legal name

Scott Kelly Consulting

Website

https://scottkellyconsulting.com

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

Scott Kelly Consulting is a Durham, NC-based boutique consultancy providing clinical research program direction, budget/contract development, and multi-party partnership management to pharmaceutical sponsors, biotechs, CROs, and academic research organizations for complex drug development programs.

Ownership category

akta.pro rank

Product category

Clinical Research Consulting

NAICS

Management Consulting Services (54161), Scientific Research and Development Services (5417)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

akta.pro secondary industries

Clinical Trial Financial Management & Payments (Site Budgeting) (HLAGACAM), Clinical Trial Site Operations & Study Coordination (HLAGACAE)

Keywords

• Clinical research consulting
• Drug development services
• Clinical trial management
• Pharmaceutical consulting
• Clinical program direction

Headquarters

HQ city

Durham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. Clinical Research Consulting Services: Professional consulting services for drug development programs, including clinical program direction, budget and contract development, partnership management, and team mentoring.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Scott Kelly Consulting provides clinical research consulting services for drug development, including clinical program direction, budget and contract development, multi-party partnership management (across sponsors, CROs, and academic consortia), investigator meeting organization, and mentoring of junior clinical staff. The firm specializes in complex clinical trials, with particular emphasis on rare disease and pediatric indications, supporting pharmaceutical and biotechnology sponsors from initiation through regulatory outcomes.

Product overview

Scott Kelly Consulting offers clinical research consulting services for drug development, providing strategic guidance and operational support for clinical trials. The company specializes in clinical program management, team leadership, and partnership coordination for complex clinical studies, particularly in rare diseases and pediatric indications. The firm operates as a solo consulting practice providing advisory services rather than a software product platform.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Research Consulting Services for Drug Development Professional consulting service for pharmaceutical sponsors, biotech companies, CROs, academic research organizations, and hospitals. Includes clinical program direction, budget and contract development, partnership management across sponsors/CROs/academic consortia, investigator meeting organization, team mentoring, and regulatory navigation for complex clinical trials with emphasis on rare disease and pediatric indications.

Named customers3 records

Segments5 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Three partnerships are on record, tiered core.

• TakedacoreStrategic or Co-development PartnerTakeda (Sr. Director Clinical Sciences Beatriz Caballero, MD) engaged Scott Kelly for pediatric IBD clinical study. Scott's clinical knowledge and management of the clinical team was instrumental in completing the study and obtaining FDA pediatric indication for Lialda. Testimonial evidence of successful collaboration.
• GenentechcoreStrategic or Co-development PartnerGenentech (Therapeutic Area Head Isobel Lakatos and Sr. VP Michael Rothenberg, MD PhD) engaged Scott as Clinical Program Director for complex early phase trial involving rare indication. Scott demonstrated expertise in budget and contract development, strategic communications, and multi-party partnership management across Genentech, expert Consortium, and CRO.
• Expert ConsortiumcoreStrategic or Co-development PartnerAcademic/medical expert consortium partnered with Genentech and CRO for rare disease clinical program. Scott Kelly instrumental in formation and ongoing management of complex three-party partnership involving industry sponsor, academic consortium, and CRO.

Scale indicators1 record

Recent moves5 records

Expansion highlights2 records

Market position

Weaknesses4 records

Competitive moat2 records

Key risks6 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/in/scottkellyconsult

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Scott Kelly Consulting