Regeneris

Center Information

Gabrielle Lewis
Director of Clinical Research
Regeneris
465 South Washington Street
North Attleboro, MA 02760
USA
(508) 316-4268
(774) 643-6154 (fax)
g.lewis@regenerismedical.com
www.regenerismedical.com/
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Currently Enrolling Trials

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Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Devices
Endocrinology
Family Medicine
Gastroenterology
Genetic Disease
Healthy Volunteers
Immunology
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma (Emergency, Injury, Surgery)
Urology
Vaccines

Center Overview

Regeneris is a full-time independent clinical research center located in southeastern Massachusetts. Our clinic is approximately 15 miles north of Providence, RI and 40 miles south of Boston in North Attleboro, MA. Regeneris is a multi-specialty clinical trial site that conducts Phase II-IV pharmaceutical and medical device clinical trials.

Our staff have collectively completed over 130 studies to date for a wide range of clients. We have a dedicated Recruiter, Regulatory Specialist, and four Clinical Research Coordinators with combined coordinating experience of over 23 years. Our Director has coordinating and managerial experience and focuses on business development, daily operations, and budget and contract negotiations. Our board certified Principal Investigator is on site five days per week.

We have an extensive database of patients and we utilize a broad array of multi media advertising campaigns as needed to extend our reach systematically throughout the community. These recruitment tactics provides us with access to an abundance of research study volunteers.

At Regeneris, our commitment to rapid enrollment while adhering to regulatory guidelines contribute to Tristan's high sponsor and patient retention rate. It is our mission to capture clean, accurate and complete data in an ethical manner and in accordance with the protocol, local and federal guidelines.

Performance Metrics

Number of Studies Conducted: 130+
Number of Studies Actually Completed: 125+
Number of Active Patients in the Database: Database of 40,000+
Regulatory Submission Turn-Around Time: 5 Business Day(s)
Average Number of Total Patients Enrolled: 25
Average Percent of Total Patients Randomized: 70%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 95%
EDC Capabilities: Yes

ACRP Certifications

Clinical Research Experience

Our staff have completed clinical research trials in the following therapeutic areas:

  • Acne
  • Acute Lower back pain
  • Allodynia
  • Alzheimer's
  • Anemia
  • Anklyosing Spondylitis
  • Asthma
  • Atherosclerosis
  • Cardiovascular
  • Cat allergy
  • C. difficile
  • Chronic Lower back pain
  • Chronic pain
  • Constipation
  • COPD
  • Diabetes
  • Diabetic painful neuropathy
  • Dust mite allergy
  • Fibromyalgia
  • Flu Vaccination
  • GERD
  • Gout
  • High Cholesterol
  • Hot Flashes
  • Hypertension
  • IBS
  • Insomnia
  • Laser hair removal
  • Migraine
  • Obesity
  • Opioid induced constipation
  • Osteoarthritis
  • Osteoporosis
  • Overactive bladder
  • Paget's Disease
  • Postherpetic neuralgia
  • Psoriasis
  • Ragweed allergy
  • Restless leg syndrome
  • Rheumatoid arthritis
  • Rosacea
  • Ulcerative colitis
  • Ulcers

Facility Description

  • Emergency Cart
  • Electrocardiogram Machines
  • Digital Vital Signs Monitors
  • Fully equipped Laboratory
  • Refrigerators for specimens
  • Refrigerated Centrifuges
  • Locked Pharmacy/Drug Storage Room with refrigerator and locked cabinets
  • Conference Room
  • Kitchen/Dining Rooms
  • Monitoring Rooms
  • 6 Patient Examination Rooms
  • Admission Area
  • 12 lead EKG
  • Biofeedback
  • Centrifuge
  • CLIA Waiver
  • Dry Ice
  • Cardiac Defibrillator
  • Diagnostic X-ray
  • Ultrasound
  • Private waiting area for extended visits
  • Beds
  • On site document Storage
  • -70 Freezer
  • -20 Freezer
  • Tristan Medical local laboratory

Investigator Experience

Ryan Welter, M.D., Ph.D. is board certified in Family Medicine and has been conducting clinical research trials as a Principal Investigator since 2011.

It is Dr. Welter's mission to ensure that all research related activities are conducted in an ethical manner, adhering to Good Clinical Practice and data is gathered in a manner congruent with the protocol. He mandates that all documentation is captured and documented according to ALCOA standards.

Dr. Welter is on site five days per week and is easily accessible to research staff and patients and to sponsors and CRO's alike. He is on site actively involved in all aspects of clinical research, providing keen oversight and keeping his finger on the pulse of this ever changing industry.

Staff Expertise



Gabrielle Lewis is the Director of Clinical Research and was certified in 2013 with the Association of Clinical Research Professionals as a Clinical Research Coordinator. She has been coordinating clinical research trials since 2000 and has been a Site Manager since 2013. Gabrielle works very closely with Dr. Welter and oversees daily operations as well as managing budget and contract negotiations.

Our Coordinators have experience working with multiple electronic data capture systems as well as with Interactive web/ voice response systems. Some of those systems include Medidata, Rave, OCRDC, DataLabs, Cenduit, Inform, Clinphone, Phase Forward and DataTrak.

At Regeneris we are very familiar with and have developed solid working relationships with several central laboratories such as Quintiles, Covance, Lab Corp., MRL, MDS, ICON ,ACM, BRL, etc.

Additionally, we have successfully collaborated with various third party vendors to efficiently collect clean data for analysis. Time and again this has been demonstrated by timely and accurate completion of many projects with organizations such as eResearch technology, BioClinica, Synarc and Cardiocore who specialize in advanced imaging.

Invivodata, ePro, CRF Health, PHT Corp. and Diary Pro are all industry leaders that simplify the process of collecting patient reported outcomes by way of providing innovative electronic devices for first hand data collection and whom we at Regeneris have intimate working knowledge of.

We pride ourselves on completing all protocol required trainings in a timely manner to expedite study start up. Some of the training programs we are familiar with are ePharmaSolutions, Blue Sky, Clintara as well as countless sponsor specific training modules via electronic means, attendance of Investigator's meetings , hosting Site Initiation visits as well as participation in all refresher training sessions as required.

All Coordinators are required to maintain current GCP training and IATA certification.

Our Regulatory Specialist is well versed in all steps require to expedite study start up, often exceeding our expectation of a five day turn around on all documents and IRB submissions. Interim reporting and submissions as well as streamlining study close out procedures fall under the Regulatory Specialists scope of duties. Our Regulatory Specialist also assists with data entry and source document creation.

All Regeneris staff members assist with patient recruitment.

Patient Demographics

White alone 66.5%
Black or African American 13.4%
American Indian and Alaska Native 0.6%
Asian 1.5%
Native Hawaiian and Other Pacific Islander 0.1%
Two or More Races 6.1%
Hispanic or Latino 19.7%

*Information sourced from www.quickfacts.census.gov

Other Information

Our site utilizes central Institutional Review Boards for our trials which facilitates speedy document submissions, turn around and approvals. We've worked with many major Central IRB’s such as Schulman, Quorum, Copernicus Group, Central, IntegReview, Liberty and Aspire IRB and maintain access to electronic submission portals with many of the boards to expedite the submission process.

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.