About Us - Clinical Development Services
Expertise
We offer expert clinical development and operations services to biotech, pharmaceutical, and medical device sponsors, drawing on over 24 years of leadership in efficient, compliant, accelerated programs from Phase I to approval and commercialization.
Our specialization in rare and ultra-rare diseases, pediatrics, cell and gene therapies, vaccines, infectious diseases, oncology, cardiology, nephrology, dermatology, and women’s health allows us to provide key offerings, including:
Clinical Strategy: Development of target product profiles (TPPs), clinical development plans (CDPs), protocols, investigator brochures, IND/BLA sections, briefing packages, and orphan designations.
Trial Execution: Comprehensive management of Phase I to IV trials across complex indications and modalities.
Infrastructure Build-Out & Scale-Up: Establishment of ICH-GCP inspection-ready quality management systems (QMS), standard operating procedures (SOPs), electronic trial master files (eTMFs), training, metrics, department establishment, team scaling, and support for organizational growth.
Vendor/CRO Management: Handling of requests for proposals (RFPs), selection processes, contracts, budgeting, forecasting, and performance oversight.
Regulatory Leadership: Active clinical involvement in meetings with FDA, EMA, and Health Canada, successful inspections, IND transfers, and asset transactions.
Post-Approval Support: Assistance with commercial transitions, registries, investigator-initiated trials (IITs), and partnerships in Medical Affairs.
Team Building: Fostering high-performing clinical teams through targeted mentoring.
Founder
Scott Rodgers, MS, CCRA, ACRP-PM Clinical Development Strategist & Operations Executive | 24+ Years Driving High-Impact Biotech & Pharma Programs
Highly accomplished clinical leader with more than two decades of executive experience spanning CROs, NIH/NIAID, and innovative biotechnology companies. He has the ability to define and execute strategic clinical development pathways that integrate scientific rationale, regulatory intelligence, risk management, competitive positioning, and commercial goals to maximize program success, de-risk investment decisions, and accelerate regulatory approval and market entry.
Certified as a Clinical Research Associate (CCRA), Clinical Project Manager (ACRP-PM), and trained in GCP auditing, Scott has led Phase I–IV development programs across diverse modalities (vaccines, biologics, gene/cell therapies, medical devices) and therapeutic areas including infectious diseases (HIV, bio-defense vaccines for smallpox, anthrax, influenza, malaria), oncology (glioblastoma multiforme, Merkel cell carcinoma, ALL, SCLC), rare and ultra-rare diseases (ADA-SCID, CTX, NEC, GNE Myopathy), cardiology, nephrology, women’s health, and more.
His strategic development expertise and regulatory leadership have delivered results:
Collaborated with medical personnel to develop overarching clinical strategies that establish clear scientific, regulatory, and commercial endpoints, prioritize indication sequencing, define optimal trial execution designs, incorporate adaptive and risk-based approaches, and align cross-functional teams around high-probability paths to approval.
Designed and operationalized clinical departments from the ground up, instituting clinical quality management systems, SOPs, eTMFs, training frameworks, and KPI-driven performance tracking that consistently achieved outstanding FDA, EMA, and Health Canada inspection outcomes with minimal or zero findings.
Authored and contributed to key regulatory submissions (INDs, NDAs, BLAs, briefing documents, orphan designations, annual reports) while participating as the clinical operations voice in FDA meetings and teleconferences and supporting medical experts, securing agency alignment on development strategies and expediting review timelines.
Successfully advanced multiple programs to approval across the US, Europe, and Japan, while orchestrating smooth hand-offs from late-stage clinical development to commercial launch, post-approval registry studies, and Investigator-Initiated Trials.
Provided executive oversight of various multimillion-dollar clinical portfolios, including strategic CRO/vendor selection through rigorous RFPs, comprehensive budget forecasting and reconciliation, proactive risk identification and mitigation, timeline optimization, and resource prioritization to consistently deliver studies on or ahead of schedule and within budget.
Scott brings a consultative, big-picture perspective that turns complex clinical and regulatory challenges into structured, executable strategies whether for early-stage companies building their first robust development framework, mid-sized sponsors optimizing indication expansion or global regulatory strategy, or organizations navigating asset transfers, out-licensing, or partnership due diligence.
For biotech and pharmaceutical leaders seeking a strategic partner to shape winning development programs, strengthen operational infrastructure, navigate complex regulatory landscapes, and deliver inspection-ready excellence, Scott provides deep strategic insight, proven execution, and a long track record of transforming ambitious science into approved, market-ready therapies.