WHEC News recently highlighted clinical trials activity in the Rochester New York area. Located in western New York State, Rochester metropolitan area includes six counties and over 1 million people. Rochester was one of America’s first boom towns due to its proximity to Lake Ontario and the fertile Genesee River Valley , supporting the growth of flour mills and then later a manufacturing hub. It has become a well-known research center with its notable universities such as the University of Rochester and Rochester Institute of Technology. Notably, Rochester has shaped past innovations—a hub where many inventions occurred—a birthplace to Kodak, Western Union, French’s, Bausch & Lomb, Gleason and Xerox. The region is a center for clinical research and hundreds of clinical trials. The recent WHEC News covered a prominent boutique, single-site clinical research center—Rochester Clinical Research (RCR).
Founded in 1994, RCR has been an important research nexus in the region. They maintain a growing volunteer database of over 20,000 and have completed over 700 studies in 20 years representing an average of approximately 35 studies per year. Their estimated size is approximately 25-50 employees. Professional network LinkedIn includes 33 self-reported employees. The venture was founded by Pat Larrabee, a trained nurse practitioner. She has been an active professional in the Rochester NY region—supporting a myriad of sponsors with research trials.
They have ongoing investments in a dedicated, full service clinical trial site providing Phase I-IV research capabilities. Their facilities include:
- 10,000 square foot facility with temperature controlled and monitored secure drug rooms
- -70 freezer, -20 freezer, cold centrifuge, regular centrifuge, stadiometer, DXA (Lunar –Prodigy machine)
- 8 Exam rooms
- 4 Dedicated monitoring rooms
- 2 large conference rooms
- On-site long-term storage for record archive (e.g. support required site ISF and sponsor TMF)
- Facility includes automatic battery powered backup system for freezer, refrigerator
- Adjacent x-ray facility, endoscopy facility
- 8 RN/study coordinators (all CCRCs)
- 2 Nurse practitioners
- 2 Lab tech/Phlebotomists
- 3 Full time volunteer recruitment specialists
- Administrative staff for regulatory preparation
- Certified DXA technician
- 4 on-site board-certified physicians including MD available everyday
- Specialist MDs for OB-GYN, Gastroenterology, Allergy and Immunology, Dermatology capabilities are available on demand
Organized and Quality-Driven
The research center reports a full and total commitment to quality. Having developed an internal audit program and ongoing quality assurance program (e.g. GcP), they also include staff education and training ongoing to bolster quality for adherence to GcP and FDA requirements. They have experience with FDA audits, discussed below.
They partner with local primary and specialty physicians around the Rochester metropolitan area to expand options for clinical volunteers. They have worked with over 200 industry, academic and government sponsors. Additionally they have engaged with most of the nations’ central IRBs, central labs and leading patient recruitment vendors. Moreover, they purport to have worked with most of the standard eClinical applications—from EDC to IXRS to electronic medical records and e-diaries.
In 2009 CEO Larrabee was quoted in Applied Clinical Trials on the topic of clinical trial management systems(CTMS). Apparently RCR had moved from a partial CTMS (including some manual processes) to a full-blow CTMS implementation to improve recruitment, scheduling workflows and to optimize KPI metrics and financial management. RCR is a single research site. The adoption of CTMS is not an easy affair. We were impressed with RCR adopting and deploying this class of technology to digitize paper processes. An indicator of commitment to quality, patient safety and productivity for their sponsor clients.
Although not large by some national standards, RCR represents a prominent clinical trials site in the Rochester region. Over the past couple of decades they have accumulated experience working in a number of different therapeutic areas including:
- Heart Medications
- Home HIV Testing
- Smoking Cessation
- Pediatric Meningitis
Known FDA Inspections
Based on TrialSite News research of FDA inspection classification database, a few interactions were uncovered. A Matthew Davis, MD was identified as principal investigator in both 2010 and 2015 inspections. In the 2010 inspection, the FDA noted a voluntary action indicated and in 2015, no action indicated. No 483 warning letters were issued. We found another inspection result as a result of an New Drug Application in 2012. BioAlliance Pharma submitted the application for the use of Acyclovir Lauriad 50 mg mucoadhesive buccal tablet in the treatment of herpes labialis in immunocompetent patients. A clinical trial (BA 2005/21/02) was submitted in support of the application. The applicant submitted this NDA to provide efficacy and safety information on the use of a single dose of acyclovir Lauriad 50 mg muco-adhesive buccal tablet. Thereafter, the FDA review division requested inspection of three clinical investigators associated with the application, including two domestic site inspections and one foreign site for the pivotal protocol Study BA2005/21/02. The consult to OSI states that these sites were chosen because, “The enrollment of large numbers of study subjects, significant primary efficacy results pertinent to decision-making and the first approval of this new NDA and most limited experience with this drug has been at foreign sites”.
One of the three sites listed was RCR and its’ investigator Matthew Davis. A summary of the FDA findings includes:
- All informed consent processes and documents we completed correctly
- All documentation was followed correctly
- Investigational plan was adhered to
- No 483 issued
“The medical records reviewed were found to be in order, organized, and the data verifiable. There were no deaths and no evidence of under-reporting of adverse events. There were no known limitations to the inspection….The data, in support of the clinical efficacy and safety at Dr. Davis’ site are considered reliable and appear acceptable in support of the application.”
The BioAlliance drug acyclovir (Sitavig) was approved in 2012.
We were able to identify a referral to RCR under a 2018 “facilities inspection” but couldn’t find any additional information.
Rochester Clinical Research (RCR) appears to be a regional and boutique, rock-solid clinical research site operating in the Rochester area. With two decades of track record, they have conducted over 700 trials with over 200 partners. With approximately 25- 50 employees, they appear appropriately organized, focused, disciplined and committed to quality and GcP. The only FDA-related materials we could find evidenced a well-run operation. Their investigators appear well-suited to conduct a myriad of clinical trials.