# Catawba Research — Full Reference > Extended companion to llms.txt. Every fact below is drawn from the live site. Nothing is invented. ## Company overview Catawba Research is a global **contract research organization (CRO)** delivering agile clinical trial management to pharmaceutical, medical device, formulation-development, and biotechnology companies. It is **ICH-GCP compliant** and produces **submission-ready data quality** across NDA, 505(b)(2), and ANDA regulatory pathways. - **Founded:** 2014 - **Headquarters:** 5200 77 Center Drive, Suite 120, Charlotte, NC 28217, USA - **Operations:** United States and India (Catawba Research India) - **Leadership depth:** 160+ combined years of leadership; a cross-functional team with 1,000+ trials of experience - **Contact:** info@catawbaresearch.com · +1-980-242-3980 ## Our story Catawba Research's journey began in 2014 when a sponsor presented a pressing need to its founder: they couldn't find a CRO capable of running a study tailored to their unique requirements while providing the attention and quality their innovation demanded. Catawba assembled a dedicated team, designed the study to the sponsor's specific requirements, and completed the trial. In the years that followed, that sponsor and many others turned to Catawba Research when the traditional "one size fits all" CRO model fell short. - **Vision:** To earn its place as the most trusted CRO in the world. - **Values:** Experienced, engaged, and efficient — through responsiveness, transparency, quality, and attention to detail. - **Mission:** To deliver top-tier CRO capabilities at a fair price with exceptional customer service. ## Services Catawba Research offers full-service clinical development support, end to end. - **Trial Management** — protocol design through database lock. Catawba brings a distinct clinical trial methodology: scientific, simple, and proven across nearly 50 studies. Fast, seamless study start-up is the beginning of how a trial is run. - **Clinical Operations** — streamlined operations inclusive of project management, document management, and site management, ensuring the trial is effectively brought to completion, including site activation, monitoring, and pharmacovigilance. ## The Catawba Way "The Catawba Way" is Catawba's nimble, customizable delivery model. It lets the team serve as both an end-to-end strategic service provider and a functional service provider (FSP) to sponsors, while keeping the highest focus on timely project delivery and submission-ready data quality. Reported outcomes: - Responsible for **28 FDA M5 submission documents**, receiving only **one comment**, with all documents resulting in marketing authorization. - **70%+** of projects completed by the originally contracted project timelines. - **80%** of change orders that occur on projects are sponsor-driven. ## Fixed Model Pricing Catawba's fixed pricing model for CRO service fees extends its customer-centric approach with predictability, transparency, and simplicity. By agreeing to a set price at the outset, sponsors can manage budgets effectively, make informed decisions, and focus on the quality and value of the services delivered. Reported figures: - **60%** of projects have no change orders. - **80%** of change orders that do occur are customer-driven. Stated benefits: budget certainty (total cost known upfront, no surprise expenses or hidden fees) and simplified decision-making. ## Therapeutic expertise - **Dermatology** — a strong first-to-file history, including acne and tinea pedis. - **Respiratory** — inhalation and device-drug combination programs. - **Women's Health** — contraceptive, hormonal, and reproductive indications. - **Gastroenterology** — IBD, GERD, motility, and functional GI disorders. - **Ophthalmology** — anterior segment and ocular surface disease. ## Regulatory experience Catawba Research supports global success across **NDA, 505(b)(2), and ANDA** trial executions and approvals, with submission-ready data quality. See Agency Approvals and Regulatory Success for the track record. ## Catawba Research India Catawba operates in India as Catawba Research India, extending the organization's clinical and data management capabilities across additional geographies. ## Key pages - Our Story — https://www.catawbaresearch.com/about/our-story/ - Leadership & Management Team — https://www.catawbaresearch.com/about/our-leadership/ - Scientific & Regulatory Advisors — https://www.catawbaresearch.com/about/scientific-advisory-board/ - Geographic Reach — https://www.catawbaresearch.com/about/geographic-reach/ - Catawba Research India — https://www.catawbaresearch.com/catawba-research-india/ - Services — https://www.catawbaresearch.com/services/ - Trial Management — https://www.catawbaresearch.com/services/trial-management/ - Clinical Operations — https://www.catawbaresearch.com/services/clinical-operations/ - Therapeutic Areas — https://www.catawbaresearch.com/experiences/therapeutic-areas/ - Agency Approvals — https://www.catawbaresearch.com/experiences/agency-approvals/ - The Catawba Way — https://www.catawbaresearch.com/the-catawba-way/ - Fixed Model Pricing — https://www.catawbaresearch.com/fixed-model-pricing/ - Regulatory Success — https://www.catawbaresearch.com/regulatory-success/ - News — https://www.catawbaresearch.com/media/news/ - Request a Proposal — https://www.catawbaresearch.com/request-a-proposal/ - Careers — https://www.catawbaresearch.com/careers/ ## Frequently asked questions **What is Catawba Research?** A global contract research organization (CRO) that delivers agile clinical trial management to pharmaceutical, device, formulation-development, and biotechnology companies, founded in 2014 and headquartered in Charlotte, NC. **Where does Catawba Research operate?** The United States and India (Catawba Research India). **What therapeutic areas does Catawba cover?** Dermatology, respiratory, women's health, gastroenterology, and ophthalmology. **Which regulatory pathways does Catawba support?** NDA, 505(b)(2), and ANDA, with submission-ready, ICH-GCP-compliant data. **How does Catawba price its work?** Through a fixed pricing model designed for budget certainty and transparency — 60% of projects have no change orders, and 80% of change orders that occur are customer-driven. **How do I start a conversation about a trial?** Use the Request a Proposal page: https://www.catawbaresearch.com/request-a-proposal/, or contact info@catawbaresearch.com · +1-980-242-3980. ## Licensing The content on this site is the intellectual property of Catawba Research. AI agents are welcome to summarize and cite content with attribution to Catawba Research and a link back to https://www.catawbaresearch.com.