About Us

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Expert clinical development and operations services to biotech, pharmaceutical, and medical device sponsors, backed by over 24 years of leadership in efficient, compliant, accelerated programs from Phase I to approval and commercialization.

Specializing in rare/ultra-rare diseases, pediatrics, cell & gene therapies, vaccines, infectious diseases, oncology, cardiology, nephrology, dermatology, and women’s health, key offerings include:

• Clinical Strategy:  TPPs, CDPs, protocols, investigator brochures, IND/BLA sections, briefing packages, orphan designations.
• Trial Execution:  Full Phase I–IV management across complex indications and modalities.
• Infrastructure Build-Out & Scale-Up:  ICH-GCP inspection-ready QMS, SOPs, eTMFs, training, metrics, department establishment, team scaling, and organizational growth support
• Vendor/CRO Management:  RFPs, selection, contracts, budgeting, forecasting, and performance oversight.
• Regulatory Leadership:  Clinical involvement in FDA/EMA/Health Canada meetings, successful inspections, IND transfers, asset transactions.
• Post-Approval Support:  Commercial transitions, registries, IITs, Medical Affairs partnerships.
• Team Building:  Developing high-performing clinical teams through targeted mentoring.

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 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.

Strategic development expertise includes:

• Collaborated with medical personnel to develop overarching clinical development strategies that establish clear scientific, regulatory, and commercial endpoints, prioritize indication sequencing, define optimal trial 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.