Expert Clinical Trial Supply Chain Consulting

A well-managed supply chain is vital for operational success. Pishock Clinical Consulting LLC offers consulting services that optimize your supply chain processes by providing comprehensive clinical trial supply chain consulting and contract services to pharmaceutical companies, CMOs, CROs, healthcare organizations, and research institutions with proven expertise and results.
I bring 30+ years of hands-on experience managing end-to-end clinical supply chains. From protocol to patient, I ensure clinical materials are packaged, labeled, shipped, and inventoried flawlessly, even under urgent, global conditions.
I specialize in solving supply chain crises and managing high-risk, short-expiry, and cold chain investigational drugs. My leadership has helped companies like Sanofi, Celgene (BMS), and AstraZeneca keep critical trials on track in a consulting capacity.
I've also supported Pfizer, Bristol Myers, Biogen, Novartis, Glaxo, Eli Lilly, Otsuka, and many other large and small pharmaceutical companies as a senior project manager and director of project management
Phase I-IV studies, protocol interpretation into a full-scale packaging and logistics project plan, site management, forecast and demand planning
I build complete packaging and logistics strategies that result in precise, apples-to-apples RFQs for vendor selection—starting even from the most general draft protocols. A one-hour consultation is often all I need to capture the required detail and deliver a fully tailored Phase I–IV supply strategy.
Need a seasoned professional to lead during transitions or accelerate deliverables? I offer interim department head support and mentorship to clinical operations teams.
Facing high attrition internally or at your vendor? I can step in to stabilize and recover your trial execution with minimal oversight.
Strategically located near major clinical packaging facilities:
Clinical trial supply project management and inventory software implementation, clinical data systems, validation, and integrity.
GMP, GCP, 21 CFR Part 11 compliance, ISO compliance, audit preparation, batch record review, and IRT UAT validation review/testing
Comprehensive clinical trial oversight from protocol development through study completion and regulatory submission.
Expert project leadership ensuring timelines, budgets, and deliverables are met with the highest quality standards at not only the sponsor, but also the vendor, CMOs, CROs, and global depots.
Develop comprehensive clinical development strategies aligned with business objectives and regulatory requirements. Furthermore, accurately break down packaging campaigns based on lot stability, drug availability, and expiry date for the most ideal forecast for demand.
Optimize clinical operations through process analysis, workflow improvement, and implementation of best practices.
Implement robust quality systems and processes to ensure compliance and improve operational efficiency.
Navigate complex regulatory requirements with expert guidance on FDA submissions, compliance strategies, and regulatory pathway optimization.
Built global distribution systems from scratch at ThermoFisher Clinical Services
All drugs packaged and delivered to patients on time—never a missed randomization
Senior PM and Director roles delivering for nearly every major pharmaceutical company
Business development success at Catalent, Sharp Clinical, Signant Health, and PAREXEL
Celgene
Sanofi
AstraZeneca
Pfizer
Insys Therapeutics
AstraZeneca
As Founder of Pishock Clinical Consulting LLC, I bring over 30 years of hands-on expertise in clinical trial supply management, packaging operations, and quality assurance compliance. My experience spans a wide range of therapeutic areas, and I'm committed to helping organizations meet their clinical goals through strategic guidance and practical implementation support.
With a proven track record of contributing to the success of 1,000+ clinical trials, I offer deep proficiency in clinical trial management, vendor oversight, and healthcare quality improvement. I deliver customized solutions that accelerate timelines, enhance compliance, and align with global regulatory standards.
Schnecksville, PA, USA
Phone: +1-484-788-4690 email: james@pishockinc.com
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