Call us directly: 617 481.0481

300 Congress Street Suite 203 Quincy MA 02169 View Location

Send us an email HERE

Sponsors

Quality Data:
To ensure quality research medRACS employs constant training in industry standards and adherence to FDA standards including protocol specific requirements. Our staff has significant clinical expertise and experience in clinical research and patient care. All of medRACS staff has experience and training in GCP and ICH guidelines for participation in pahse I-IV clinical research.

medRACS delivers quality research by paying diligent attention to detail and employing investigators and staff that are dedicated to research. Our staff consists of the following:

  • 3 Primary Investigators
  • 2 Clinical Research Coordinators
  • 1 Clinical Research Associate
  • 1 Patient Advocate
  • 1 Marketing/Recruitment Manager
  • 1 Regulatory/Documentation Specialist

medRACS drives successful study completion by exceeding enrollment targets, retaining patient participation, ensuring compliance and study completion. medRACS is able to deliver successful study completion by adhering to study protocol and continual education of staff and patients.

Quality Assurance:
medRACS conducts continuous education, evaluation and of staff and Primary Investigators. medRACS reviews and audits its internal SOP’s and processes to ensure data integrity and optimal quality.
Principal Investigators (PI’s) directly oversee and direct protocol activity.
Concise, Timely and Accurate data reporting.
Training on Quality Assurance metrics to ensure compliance to FDA guidelines and protocol specifics.
Use of SOP’s including Informed Consent, Drug accountability, Adverse Event Reporting, Drug Storage, Source Document Handling, Patient Privacy and Rights, and Chart Management.
OSHA compliance.
Initial and ongoing training on study protocols and source document reviews.
Immediate and appropriate response to protocol changes and sponsor requests.

medRACS Clinical Research’s Facility

The center has the following Equipment/Facility and Diagnostic Services:

Equipment/Facility:Medical

  • Electrocardiogram Machines
  • Emergency Cart
  • Digital Vital Signs Monitors
  • 12 lead EKG
  • Biofeedback
  • Fully equipped Laboratory
  • Centrifuges
  • Refrigerated Centrifuges
  • Refrigerators for specimens
  • Dry Ice
  • -20° Freezer
  • -70° Freezer
  • Pharmacy/Drug Storage Room with refrigerator
  • Conference Room
  • Monitoring/Screening Rooms
  • Patient Examination Rooms

Equipment/Facility:Ophthalmology

  • Comprehensive Ophthalmology testing equipment and trained staff

Therapeutic Areas of Interest:

  • Acne
  • Allergies
  • Anxiety
  • Asthma
  • Astigmatism
  • Back Pain
  • Birth Control
  • Cataracts
  • Cornea Defects
  • Chronic Obstructive Pulmonary (COPD)
  • Crohn’s Disease
  • Chronic Pain
  • Cold
  • Constipation
  • Dementia
  • Dermatitis
  • Diabetes (Type I)
  • Diabetes (Type II)
  • Diabetes (Type II) Weight Loss
  • Diabetic Peripheral Neuropathy
  • Diabetic Retinopathy
  • Depression
  • Dry Eye
  • Eczema
  • Fibromyalgia
  • Epilepsy
  • Erectile Dysfunction
  • Gastro esophageal Reflux Disease (GERD)
  • Glaucoma
  • Gout
  • Headache (Moderate to Severe)
  • Healthy Male
  • Healthy Female
  • Heartburn
  • High Blood Pressure
  • High Cholesterol
  • Insomnia
  • Irritable Bowel Syndrome (IBS)
  • Low Back Pain
  • Migraine
  • Multiple Sclerosis (MS)
  • Nerve Pain
  • Osteoarthritis
  • Osteoporosis
  • Over Active Bladder
  • Parkinson’s Disease
  • Pneumonia
  • Post Herpetic Neuralgia
  • Psoriasis
  • Refractive Vision Correction
  • Restless Leg Syndrome
  • Retinopathy
  • Rheumatoid Arthritis
  • Shingles
  • Sinusitis
  • Skin Infection
  • Smoking Cessation
  • Strep Throat
  • Urinary Tract Infection (UTI)
  • Vaccines
  • Vertigo
  • Weight Loss

Recruitment Strategy

medRACS is dedicated to meeting Recruitment targets!
To maximize recruitment efforts, medRACS has developed relationships with several major primary care and specilaty groups to be able to recruit from a broad base of patients and disease states.

Study Participants will be identified per HIPAA guidelines using:

  • Current research patient database
  • Referrals from affiliate medical practices
  • Advertising: internet, newspapers, radio, TV, flyers (utilizing IRB approved materials and resources)

Informed Consent Process:

  • Participants are presented with the Informed Consent documents and required to read and review with Principal Investigator and Coordinator according to FDA guidelines.
  • During active recruitment all coordinators are available for Informed Consent process.
  • Concentrated and centralized Informed Consent Process to ensure accuracy and completion of documents.
  • Participants are allowed appropriate time and access to staff to make a well educated decision.

Study Documentation and Monitoring

  • Primary Coordinator identified for study oversight and is responsible for maintaining research study records
  • Experience and expertise with Electronic Data Capture Systems (EDC)
  • Records and CRF’s are kept on site.
  • Study monitor has ready access to medical charts for direct review.
  • Experience creating critical non-CRF source documents for accurate record keeping and documentation.

Regulatory History

The FDA has Never audited the Principal Investigators or medRACS

Institutional Review Board:

  • medRACs utilizes Central IRB and is not required to use a local IRB