Palm Beach CRO is a full service contract research organization (CRO) providing clients and sponsors full clinical trial expertise throughout North America. We are a therapeutically focused CRO that provides clinical support to pharmaceutical (RX and OTC), biotechnology, nutraceutical, dietary supplements and medical device companies. As a small to medium size CRO, we are able to provide high quality and cost efficient services, rapid turnaround and proactive efforts to deliver on-time completion. In addition, the attention to details by the vastly experienced founders and staff offer strategic clinical insight and operational flexibility.
The programs Palm Beach CRO manage range from proof-of-concept studies, small multicenter trials through large Phase III.
Therapeutic Areas of Expertise
We pride ourselves in being proactive and have worked in the following clinical areas: cardiovascular (hypertension, angina, arrhythmias, CHF); Dermatology (alopecia, eczema, psoriasis, seborrhea, onychomycosis); Gastrointestinal (ulcerative colitis, IBS, GERD); Skeletal (OA, RA); Muscular (spasms); Pulmonology (Asthma, COPD); CNS (opiod, NSAID, sleep, pain); Women’s Health care (vulvovaginal infections, postmenopausal, HRT); Nutritional (Satiety, weight loss, osteoarthritis); Oncology; Urology (OBD, SUI)
Palm Beach CRO Services Offered
o Regulatory strategy development
o IND and IDE submissions and maintenance (including Annual Reports)
o GCP, GLP and GMP audits
o Develop strategy and run Pre-IND, Pre-NDA meetings
o Pre-IND, Pre-NDA briefing packages
o Presentations to the FDA
o Negotiations with FDA
o Responses to FDA inspections (483s) and other FDA correspondence
o 505(b)(2) strategy and NDA submissions
o eCTD preparation (CSE, CSS, ISE, ISS)
o Due diligence for technology licensing
o Toxicology package development
Palm Beach CRO manages the entire clinical trial process and our core strength is to provide quality data with properly developed timelines. Our teams of seasoned professionals are proactive in the clinical process, helping to reduce costs and prevent overruns of budgets.