LGBT Cancer Project

National Pain Research Institute, LLC

Center Information

Joan Cutillo, LPN, CCRC
Clinical Research Director
National Pain Research Institute, LLC
1693 Lee Rd.
Winter Park, FL 32789
USA
407-203-7936
561-515-8869 (fax)
joan.cutillo@prospirapc.com
www.natpain.com/research.html
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Therapeutic Areas

Devices
Musculoskeletal
Neurology
Oncology

Center Overview

The National Pain Research Institute, LLC, is a division of the National Pain Institute, a Prospira PainCare Center of Excellence, with over 13 locations throughout the state of Florida. The National Pain Institute is dedicated to providing quality care for those who are suffering with acute, sub-acute or chronic pain. We operate interdisciplinary regional centers of excellence and we are a national leader in the evaluation and management of painful disorders.

Our research department, the National Pain Research Institute, LLC, is currently conducting clinical trials in our Winter Park and Port St. Lucie offices. We are a full time, dedicated site, with full time certified coordinators and sub-investigators.

Our unique interdisciplinary treatment approach has been determined to be the most effective methodology according to the American Academy of Pain Management. We have the ability to conduct clinical trials involving all areas of the chronic pain syndrome.

Our mission statement:

The National Pain Research Institute, LLC is a clinical investigative site dedicated to providing our subjects with qualified professionals who utilize good clinical practices to ensure the subject’s safety and well being. Through our clinical trials, subjects are offered access to new medical treatments and devices. Quality data is routinely provided to our sponsors, which aids in maintaining the safety and efficacy of the trials we participate in. It is our duty to the people we serve in our community to offer the highest ethical standard of medical care and the opportunity to improve their quality of life through our clinical trials.

Performance Metrics

Number of Studies Conducted: >25
Number of Studies Actually Completed: 21
Number of Active Patients in the Database: 50
Regulatory Submission Turn-Around Time: 10 Business Day(s)
Average Number of Total Patients Enrolled: 15
Average Percent of Total Patients Randomized: 70%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 90%
EDC Capabilities: Yes

Staff Certifications
Number of Certified CRCs: 2

Clinical Research Experience

Our clinical trials department has been operating since April 2007 and we have performed over 25 clinical trials since then. Our coordinators are highly trained and experienced with such certifications as ACRP CCRC, lATA Cert, NIH training, as well as a working knowledge of GCP/ICH guidelines and the CFR. All of our coordinators are trained in phlebotomy, EKG, breathalizers, UDS onsite testing, EDC trained on multiple systems, eDiary proficient on many different systems and trial slate experience.

Our PI and coordinators have worked with many companies throughout their research experience, such as:

  • Biogen
  • Seikagaku (device)
  • Daiichi Sankyo
  • Shionogi
  • Mallinckrodt
  • Endo Pharmaceuticals
  • Purdue Pharma
  • Astra Zeneca
  • Meagan Medical (device)
  • Medtronics (device)
  • Astra Zeneca
  • Meagan Medical (device)
  • Ferring Pharmaceuticals
  • Fralex Therapeutics (device)
  • Wyeth Pharmaceuticals
  • Progenics Pharmaceuticals
  • Insys Therapeutics
  • Pfizer
  • GlaxoSmithKline
  • Bard
  • Eli Lilly
  • Bristol Myers Squibb
  • Fziomed
  • BoehringerIngelheim
  • Orthologic Corp
  • 3M Pharma
  • Amgen
  • Taro Pharmaceuticals
  • Merz Pharmaceuticals
  • Barrier Therapeutics
  • Galderma Laboratories
  • Atrix Laboratories
  • Xoma Inc.
  • Dow Pharmaceuticals
  • Genentech, Inc

Our center specializes in all aspects of chronic pain. Some conditions are a result of a patient's chronic pain that they live with daily. We are a multi-disciplinary site that treats the whole patient. Our areas of therapeutic interest are:

  • Degenerative Spine Disease
  • Low Back Pain
  • Neuropathies
  • Radiculopathies
  • Fibromyalgia
  • Migraines/Headaches
  • Osteoarthritis
  • Post menopausal osteoporosis/arthritis
  • Opioid Induced constipation
  • Musculoskeletal disorders
  • Malignant Pain
  • And many others

Facility Description

Our interdisciplinary site offers multi-therapeutic outpatient care to our patients. Our patients are seen by Board Certified MDs and have the opportunity to have their entire treatment plan carried out in our office.

Our facility has X-ray capabilities as well as EMGs, ECGs, and phlebotomy. We have infusion therapy for subjects requiring it. In our surgical procedure room we perform cervical and lumbar epidurals, cervical and lumbar Facet injections, flouroscopic guided Radio Frequency Lesioning, nerve blocks, trigger point injections, implantable medication dispensing pump trials, spinal cord stimulation trials and joint injections.

Our Winter Park office is just outside the city of Orlando. We are the largest pain management facility in the Central Florida area. We have direct access to the public transportation system with bus stops right outside our door.

Our Port St. Lucie facility is located directly off of I-95, in the heart of St. Lucie West. It also has easy access to the public transportation system.

Both of our facilities are less than an hour to the nearest international airport.

Investigator Experience

Jack Miletic, M.D., PI/Sub Investigator
Dr. Miletic has been with National Pain Institute since 2009. He is the Medical Director, Principal Investigator and Sub-Investigator of our Winter Park, Fl office. Dr. Miletic is Board Certified in Physical Medicine and Rehabilitation and Pain Management. He has written protocols for Investigator initiated trials we are performing in our facility as well as serving as Principal and Sub Investigator on many of our current industry trials. Dr. Miletic is NIH trained for Human Research Subject protection and is GCP trained before every new trial. He has authored on spinal disorders as well as worked on spinal research before coming to National Pain Institute.

Cherian K. Sajan, M.D., PI/Sub Investigator
Dr. Sajan has been with National Pain Institute since 2011. He completed a pain fellowship with us and went on to become an attending physician, principal investigator and sub-investigator. Dr. Sajan is Board Certified in Physical Medicine and Rehabilitation and Pain Management. He is NIH trained for Human Research Subject protection and is GCP trained before every new trial. Dr. Sajan is committed to the research department and is actively involved in study feasibility, recruitment and assessment of our research patients.

Anthony F. Afong, M.D., Principal Investigator, M.D.
Dr. Afong has been with National Pain Institute since 2006. He started with us as a fellow and went on to become medical director and principal investigator of our Port St Lucie, Fl, office. Dr. Afong is NIH and GCP trained and has conducted trials in Chronic Low Back Pain, Opioid Induced Constipation and Intrathecal Hydromorphone for Chronic Pain. He is instrumental in the study feasibility and recruitment aspects of pretrial selection for his site.

Staff Expertise

Joan E. Cutillo, LPN, CCRC
Clinical Research Director
Joan is the research director of our Winter Park office where she oversees two full time coordinators and 3 investigators, while conducting anywhere from 3 to 5 trials at a time. Joan received her nursing degree in 1995 and started research in 2002. She received her research certification from ACRP in April of 2006. Joan has managed research sites in New York and Florida. With over 12 yrs of research experience, she is well trained in regulatory, budget and contract issues, as well as being a coordinator for over 10 yrs. She is also responsible for training and monitoring the site's coordinators and investigators. Joan's knowledge of GCPs and ICH guidelines is responsible for the confidence our site receives from sponsors. She was voted 1st runner up in the Pharma Times US National Research Competition in 2010 for the research coordinator category. There were over 1000 research coordinator contestants in that competition. Joan was also a presenter at the annual conference for the American Congress of Rehabilitative Medicine in Toronto, Canada in October 2014. She presented an instructional lecture for all new and potential investigators on how to build and effectively run a clinical trials department in their own practice.

Curshinda Galvin-Burch, MA, CCRC
Curshinda has been with National Pain Institute since 2009. She is the full time lead CCRC for our Winter Park, FL office. Curshinda is well trained in EKG, phlebotomy, EDC on many systems, eDiary, UDS, site tablets and IATA certification for shipping dangerous goods. She completes monitoring visits, Site Initiation, close out visits, source creation and total conduction of each protocol. Curshinda is a knowledgeable and reliable certified research coordinator that maintains a high quality of work sought after by our sponsors. She also takes part in the training of our newer coordinators and the inservicing of our physicians on new protocols.

Christopher Taylor, CMA, CRC
Christopher comes to us as an experienced medical assistant and phlebotomist with great attention to detail. He started with us August of 2015. He is working towards his CCRC certification. His attention to detail and strong work ethic is an asset to our department. He is trained in GCPs and the protection of human research subjects (NIH).

Patient Demographics

Our patient population is primarily between the ages of 40 to 75. We treat patients from the age of 18 and up. Chronic pain patients have many different diagnosis and issues they are being treated for. It is a very comprehensive specialty. Our chronic pain patient database consists of over 6000 patients. We can draw patients from 3 different surrounding counties from both of our central locations. Our patient population allows us to draw from a geriatric population as well as younger groups of patients. Chronic pain diseases include all age groups. We not only draw from age related disease patients but from traumatic injury patients as well.

Other Information

The National Pain Research Institute, LLC, is able to use a central IRB. We have experience with many of the central IRBs: WIRB, Quorum, Schulman, NEIRB, Coast IRB, Aspire IRB, Copernicus and others.

We also have legal counsel who will consult on contract issues, and HIPAA compliance.

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.