Hi, I'm Lora Pea.

A clinical research operations consultant helps research organizations optimize their clinical trial operations — from launching new investigative sites and developing SOPs to negotiating Clinical Trial Agreements (CTAs), preparing for FDA audits, and building high-performing research teams. I bring 20+ years of hands-on experience to help sites run compliant, efficient, and profitable operations.

I provide end-to-end site startup support including regulatory submissions (IRB/IEC, FDA Form 1572), SOP and workflow development, staff recruitment and onboarding, vendor qualification, and operational infrastructure setup. My frameworks are refined across 250+ clinical trials and ensure your site is enrollment-ready with compliant operations from day one.

I have extensive experience across CNS (neurology, psychiatry), dermatology, and metabolic therapeutic areas, covering Phase I through Phase IV clinical trials. My career spans 250+ trials managed and 112 sites led across these specialties.

I conduct comprehensive gap analyses of your regulatory documents, source documentation, and quality systems. This includes mock audits that simulate FDA inspection procedures, document remediation, corrective action plans, and implementation of quality management systems. I maintain a track record of zero critical findings across all sites I've prepared.

A Clinical Trial Agreement is the contract between a sponsor and a research site that outlines responsibilities, payment terms, and liability provisions. Effective CTA negotiation ensures fair market value compensation, protects your site legally, and establishes clear expectations. I review contracts, develop study budgets, assess fair market value, and manage amendments throughout the trial lifecycle.

Yes. Whether you're launching your first clinical research site or optimizing an established multi-site portfolio, I tailor my approach to where you are. New sites benefit from my startup frameworks and regulatory guidance, while established sites leverage my expertise in operational efficiency, team development, and audit readiness.

I'm a Registered Nurse (RN) and Certified Clinical Research Coordinator (CCRC) with over 20 years in clinical research. My career includes serving as Managing Partner & Director of Clinical Operations at K2 Medical Research, Senior Manager of Global Feasibility at ICON/Accellacare (112+ sites across 8 countries), and Director of Clinical Research at Olympian Clinical Research where I scaled the team from 2 to 30+ staff.

Email me directly at [email protected] or use the contact form on this page. During our initial conversation, I'll learn about your organization's needs and recommend a tailored consulting engagement — whether that's site startup support, audit preparation, CTA negotiation, or team development.

A Contract Research Organization (CRO) like IQVIA, ICON, or PPD provides clinical trial services at scale with large teams and corporate overhead. An independent consultant like LP Clinical Consulting offers the same depth of expertise — I worked at ICON/Accellacare — but with direct senior-level access, lower cost, more flexibility, and personal accountability. For site-level operations, consulting, and audit readiness, an independent consultant is often more cost-effective and responsive than a large CRO.

Costs vary based on therapeutic area, regulatory requirements, and existing infrastructure. A physician practice adding research to an existing clinic will have different costs than a hospital building a dedicated research center. I provide realistic budget estimates based on your specific situation, covering staffing, technology, regulatory submissions, and operational infrastructure — and I help you plan to recoup that investment through study revenue.