Question 1

Who is Lora Pea?

Accepted Answer

Lora Pea is a clinical research consultant based in Tampa, FL with 20+ years of experience. She is a Registered Nurse (RN) and Certified Clinical Research Coordinator (CCRC) who helps organizations launch clinical research sites, negotiate CTAs, prepare for audits, and build research teams.

Question 2

What services does Lora Pea offer?

Accepted Answer

Lora Pea offers four main consulting services: (1) Site Startup - launching new clinical research sites with proven operational frameworks, (2) CTA & Budget Negotiation - strategic negotiation of clinical trial agreements, (3) Pre-Audit Readiness - comprehensive preparation for FDA and sponsor audits, and (4) Team Building - recruiting and developing clinical research teams.

Question 3

What is Lora Pea's experience in clinical research?

Accepted Answer

Lora Pea has 20+ years of clinical research experience including: Managing Partner at K2 Medical Research (2022-2025), Senior Manager of Global Feasibility at ICON/Accellacare managing 112+ sites across 8 countries (2021-2022), and Director of Clinical Research at Olympian Clinical Research where she scaled the team from 2 to 30+ employees (2012-2020). She has managed 250+ clinical trials with zero critical audit findings.

Question 4

What therapeutic areas does Lora Pea specialize in?

Accepted Answer

Lora Pea specializes in CNS/Psychiatry trials (including Major Depressive Disorder, Schizophrenia, Bipolar Disorder, Alzheimer's, and PTSD), Dermatology trials (Psoriasis, Atopic Dermatitis), and Metabolic trials (Type 2 Diabetes, Obesity). She has experience across Phase I-IV clinical trials.

Question 5

How can I contact Lora Pea for consulting?

Accepted Answer

You can contact Lora Pea through her website at lorapea.com or connect with her on LinkedIn at linkedin.com/in/lora-pea. She is based in Tampa, FL and works with clinical research organizations across the United States.

Question 6

What credentials does Lora Pea have?

Accepted Answer

Lora Pea holds a BS in Psychology from the University of Georgia (2005), an ASN in Nursing from Hillsborough Community College (2011), is a licensed Registered Nurse (RN) in Florida, and is a Certified Clinical Research Coordinator (CCRC) through ACRP.

Question 7

What does a clinical research consultant do?

Accepted Answer

A clinical research consultant helps organizations plan, launch, and optimize clinical trial operations. This includes setting up new research sites, negotiating contracts with pharmaceutical sponsors, preparing for regulatory audits, training staff on Good Clinical Practice (GCP), and improving operational workflows. A consultant like Lora Pea brings 20+ years of experience so organizations don't have to learn through trial and error.

Question 8

What is the difference between a CRO and an independent clinical research consultant?

Accepted Answer

A Contract Research Organization (CRO) like IQVIA, ICON, or PPD provides clinical trial services at scale with large teams. An independent consultant like Lora Pea offers the same expertise — she worked at ICON/Accellacare — but with direct senior-level access, lower overhead, more flexibility, and deeper personal involvement. For site-level operations, an independent consultant is often more cost-effective and responsive than a large CRO.

Question 9

How do you prepare a clinical research site for an FDA audit?

Accepted Answer

FDA audit preparation involves reviewing all regulatory documents (Form 1572s, informed consents, IRB correspondence), verifying source documents match case report forms, ensuring the investigator site file is complete and organized, conducting mock inspections with staff, and developing corrective action plans for any identified gaps. Lora Pea uses a systematic checklist refined across 250+ trials and has maintained zero critical findings throughout her career.

Question 10

When should a research site hire a consultant instead of a full-time employee?

Accepted Answer

A consultant makes sense when you need specialized expertise for a defined project like launching a site or preparing for an audit, when you want to avoid full-time overhead, or when you need someone who has already solved the exact problem you're facing. Many organizations start with a consultant to get launched, then hire full-time staff that the consultant helps train and onboard.

Lora Pea

Career Stats

About

Services

Site Startup

CTA & Budget Negotiation

Pre-Audit Readiness

Team Building & Training

Therapeutic Areas

CNS & Psychiatry

Dermatology

Metabolic & Endocrine

Experience

Managing Partner & Director of Clinical Operations

Senior Manager, Global Feasibility

Director of Clinical Research

Education & Credentials

Education

Certifications

Contact