BUNIONECTOMY CLINICAL SITE SERVICES

OVERVIEW

Lotus provides two clinical sites that boast state-of-the-art facilities and a track record of rapid and reliable enrollment into acute pain bunionectomy registration studies.


Methodological features are standardized across sites. A particular effort is made to reduce intra and inter-site variability by homogenizing the:

  • Surgical technique: first metatarsal Austin bunionectomy without collateral procedures
  • Anesthetic technique: propofol sedation with mayo block; procedure performed with or without popliteal block depending on protocol requirements
  • Recovery room procedures: standardized analgesic regimens, avoidance of ice, ambulation disallowed
  • Inpatient stay: private rooms, co-mingling discouraged, restricted ambulation, no visitation from family or friends


All our sites utilize the Lotus subject placebo response education toolkit. Staff members are trained yearly in techniques to reduce placebo response and properly administer analgesic questionnaires in order to reduce variability.


ENROLLMENT

Average enrollment is 30 randomized subjects per site per month (60 subjects per month total from both sites). Screen failure rates are typically low but are dependent on the specifics of the clinical protocol and its inclusion/exclusion criteria. If a faster rate of enrollment is required, Lotus will contract with additional bunionectomy sites to support enrollment rates of up to 120 subjects per month.


HISTORY

The Lotus sites have successfully contributed to several registration studies with subsequent FDA approvals. Site activities for these programs were audited by the FDA. The audit results were clean and no 483’s were issued.


CONFINEMENT/EQUIPMENT

The Lotus sites have overnight facilities so that subjects can be confined for up to five days. All sites have a double locked narcotics room, a refrigerated centrifuge, a -70 freezer, and full PK capabilities.


CONTEMPORANEOUS PHARMACOKINETIC / PHARMACODYNAMIC ASSESSMENTS

The Lotus phase 1 team is skilled in pharmacokinetic assessment and processing. All staff who handle blood products are IATA certified. The unit is equipped with a refrigerated centrifuge and -70 freezer.


DOUBLE STOPWATCH TECHNIQUE

Staff has had extensive experience with the double stopwatch methodology. Subjects are trained with our proprietary tools to understand the difference between perceptible and meaningful relief.


TURNKEY OPERATION

At Lotus we provide all services required for phase II or phase III bunionectomy programs including: multisite subject enrollment, project management, protocol writing, regulatory correspondence, data management, monitoring, CSR generation, statistical support and most importantly scientific expertise.


OUR SITES AND INVESTIGATORS:

COORDINATING INVESTIGATOR

Dr. Neil Singla serves as the coordinating investigator for our bunionectomy clinical programs. He is involved with initial protocol writing and methodological considerations specific to the investigational product. If initial correspondence with the agency is required, Dr. Singla frequently serves as the sponsor's advocate and consultant. After the protocol development phase is complete, Dr. Singla oversees the study to idealize and manage scientific conduct at all sites.


PASADENA SITE

Dr. Fardin Hakakian is an experienced principal investigator who has performed multiple studies on acute pain after bunionectomy. He is board certified in Podiatric Medicine and Surgery by the American Council of Certified Podiatric Physicians and Surgeons. The Pasadena site is located inside Huntington Memorial Hospital. It features private rooms and a 40 bed capacity.


BAKERSFIELD SITE

Dr. John Zimmerman began conducting clinical research in 1998. His main area of expertise is acute pain following first metatarsal bunionectomy. Since 2003, he has enrolled over 400 patients in 12 bunionectomy programs. The Bakersfield site is a 3000 ft.² facility dedicated to analgesic research featuring eight private rooms.