Einstein Clinical Research, Inc.

Center Information

Marilyn Moran
Director of Research
Einstein Clinical Research, Inc.
3440 Toringdon Way, Suite 205
Charlotte, NC 28277
USA
704-842-3771
877-258-8017 (fax)
einsteinclinical@twc.com
einsteinclinicalresearch.com
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Currently Enrolling Trials

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Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Devices
Endocrinology
Family Medicine
Gastroenterology
Healthy Volunteers
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Nutrition and Weight Loss
Pediatrics/Neonatology
Podiatry
Pulmonary/Respiratory Diseases
Sleep
Vaccines

Center Overview

Einstein Clinical Research is an integrated site management company with highly qualified research physicians located throughout the United States. Each physician is board certified in their specialty and certified in GCP by The Collaborative Institute Training Initiative (CITI) and the National Institute of health (NIH). The company started in 2012 with a single center and in 3 short years has grown to over 10 centers nationally. Each center has 2 Clinical Research Coordinators and a Medical Assistant all of which have GCP and HIPAA certifications. Each coordinator is either an RN, LPN or medical assistant.

We have streamlined the process of running clinical trials by incorporating two distinct procedures EPR and RSS. "Effective patient recruiting" (EPR) was developed to enhance each coordinators capability to identify patients quickly and provide accurate feasibility data. "Rapid Study Start-Up" (RSS) is utilized by our operations department in Charlotte to provide shorter turnaround time for Budgets, Contracts and IRB submissions (24-48hrs.)

Patients are recruited directly from each physician’s database, and are thoroughly pre-screened prior to submitting feasibility data. This generates reliable information regarding each site’s capability to successfully perform patient recruitment. In addition, quality assurance checks are performed throughout the entire study. This aids in providing the highest level of data integrity. Our objective is to always provide a positive research experience for each patient while providing accurate and consistent data to our sponsors.

Performance Metrics

Number of Studies Conducted: 20+
Number of Studies Actually Completed: 18
Number of Active Patients in the Database: 50000
Regulatory Submission Turn-Around Time: 1 Business Day(s)
Average Number of Total Patients Enrolled: 24
Average Percent of Total Patients Randomized: 87%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 90%
EDC Capabilities: Yes

ACRP Certifications

Clinical Research Experience

Highly Specialized areas of expertise:

  • Cardiovascular (long term outcome studies)
  • Cardiology/Vascular Diseases
  • Sleep
  • Endocrinology
  • Rheumatology
  • Pulmonary
  • Podiatry
  • Pain Management
  • Dermatology
  • Pediatrics
  • Internal Medicine
  • Family Medicine
  • Geriatric Medicine

Moderate to Complex studies:

  • Pk studies
  • Afib studies
  • Registry studies
  • Pediatric and Adult Vaccine studies
  • Cardiovascular Imaging Trials
  • Obesity
  • Hyperlipidemia
  • Hyperglycemia
  • Hypertension
  • High Cholesterol
  • Type II Diabetes
  • COPD
  • Diabetic Foot Ulcer studies
  • Cardiovascular Device studies
  • Flu studies
  • Milk Allergy studies
  • Device studies-In vitro diagnostic testing
  • RSV studies
  • Pneumonia trials- In patient

Please call 704-315-1796 for a comprehensive list of the CRO's and Sponsors we have worked with. Ask about our recent achievements as noted as one of the highest enrolling sites in the southeast.

Facility Description

  • Access to Beds
  • -20° Freezer
  • Emergency Cart
  • Electrocardiogram Machines
  • Digital Vital Signs Monitors
  • Fully Equipped Laboratory
  • Refrigerators for specimens
  • Centrifuges
  • Pharmacy/Drug Storage Room with refrigerator
  • Conference Room
  • Monitoring Rooms
  • Patient Examination Rooms
  • Recreation/TV Rooms
  • Admission Area
  • Outpatient/Screening Area
  • 12 lead EKG
  • CLIA Waiver
  • Dry Ice
  • Blood Pressure Management
  • Cholesterol Management
  • CT Coronary Angiogram
  • Defibrillator Implantation
  • Duplex Ultrasonography
  • Echocardiography
  • Holter/ Event Monitor
  • NuclearStressTesting
  • Pacemaker Implantation
  • Sleep Studies
  • Vascular Studies

Investigator Experience

Dr. A. Shah, Cardiologist, M.D. ,FACC, FSCAI- PI 20 yrs.

Dr. V. Shah, Cardiologist, M.D., FACC- PI 15 yrs

Dr. Passi, Cardiologist, MD, FACC- PI 3 yrs.

Dr. G. Virgo, Pediatrics, M.D., Board Certified- PI 20 yrs.

Dr. J. Nadaradart, Podiatrist, N.P.M, Board Certified- PI 10 yrs.

Dr. L. Green, M.D., Internal Medicine, Board Certified- PI 3 yrs.

All physicians are board certified in their speciality.

Staff Expertise

Marilyn Moran, B.S., M.B.A. Founder and Chief Operating Officer

25 years of experience in pharmaceutical research, focused on potential therapeutic advances for the management of diabetes, cardiovascular disease, rheumatoid and osteoarthritis, pulmonary disease, Alzheimer’s disease, and cancer. Prior employment with Sanofi, Novartis, Merck, Schering-Plough, Pfizer, and J&J.

Ms. Moran supported the development, for example, of drug products Lipitor and Starlix, and the J&J-introduced Cypher coated stent medical device. Significant accomplishments include standardizing programs for field monitoring, developing training programs for clinical research coordinators and research physicians, and successfully managing large scale clinical programs. Ms. Moran has developed a nationwide group of independent research physicians, while simultaneously standardizing the way each site conducts research.

Patient Demographics

Patient recruitment comes directly from each physicians EMR database and is queried according to the specifications for each protocol providing real time feasibility data.

SOP requires each site to provide feasibility data directly from their EMR. Our general practice is to present this blinded list of potential patients at each prestudy visit that matches the i/e criteria, thus making it efficient for rapid study enrollment.

Patient population depends on each sites location and can be seen under individual states where Einstein clinical is present, in. NC, SC, NJ, DE, MD.

Other Information

Announcement: Einstein is opening a new multi-therapeutic Research Center in Charlotte, N.C. Spring 2016.

All sites utilize Central IRB's
IRB turnaround 24 hours
Budget and Contract 48 hours
Rapid Study Start-Up
Accurate Feasibility data
Rapid Enrollment
Clean data

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.