We are experts in research related to the lower extremities (i.e., tibial tuberosity to the distal foot phalanges). Our experience includes Proof of Concept studies to phase I to III studies. Franco & Co consists of two medical offices fully equipped to conduct research. Offices are located in Miramar (Broward County) and Hialeah (Miami Dade County). Our multispecialty team gives us the bench strength to run a study from start up to close out.
Participant safety is our primary concern, therefore, all team members are fully trained in Good Clinical Practices (GCP) and trained in additional ethics and regulations of human subject protections. We are known for our keen attention to detail and our ability to deliver quality results within Sponsor defined protocol requirements.
Whether an investigational product or a medical device, Sponsors can count on Franco & Co to meet their research requirements within study timelines. We welcome the opportunity to discuss any of our clinical trial research sites, activities, and capabilities.
ERCHONIA® FX-635™ A double-blind, placebo-controlled randomized evaluation of the effect of the Erchonia® FX-635™ on diabetic peripheral neuropathy pain clinical study protocol (ClinicalTrials.gov)
Frequently Asked Questions
- How long does it take to complete a feasibility questionnaire? 2 days.
- How long is the budgeting and contracts process? Typically 1-2 weeks.
- How long does it take to get IRB approval? We typically use WIRB and it takes approximately 1-2 weeks.
- Who is the Principal Investigator? Dr. Sandra Franco is typically listed as the Principal Investigator on the FDA Form 1572. Dr. Franco is a podiatric surgeon who has conducted bench research in South Korea and has served as a medical monitor on several studies in various therapeutic areas. She also has extensive experience with protocol design and development, Investigator Brochure review, electronic case report form design and review. Currently, she is focusing her involvement in global clinical trials as a PI.
- What surgical training does the PI have? Dr. Franco was trained in all lower extremity surgeries with a three year Residency Degree in forefoot, midfoot, and lower extremity wound care.
- How extensive is Dr. Franco’s knowledge of wound care? She received her wound care training during her three year Residency Program and has a certificate from Healogics in wound care and hyperbaric medicine.
- Where are the clinical research units located? Franco & Co consists of two medical offices fully equipped to conduct research. Offices are located conveniently in Broward County and Miami Dade County. The Miramar office (Broward County) is approximately 3 miles from the Florida Turnpike and less than 5 miles from Memorial Hospital West. The Hialeah office (Miami Dade County) is located on the campus of Hialeah Hospital.
- How far are airports from each CRU? Miami International Airport is less than 20 minutes from the Hialeah CRU and Fort Lauderdale International Airport is less than 30 minutes from the Miramar CRU.
- What is the potential subject population? According to the most recent census, the racial distributions are as follows; 54.1% White, 16.9% African American (includes Afro-Caribbeans), 2.9% Asian American, 0.5 Native Americans, 25.6% are Hispanics or Latino (of any ethnicity or national origin).