Sponsor Information

For Sponsors

Since 1985, Clinical Research Institute has conducted over 800 phase II, III, and IV clinical studies in a variety of therapeutic areas including asthma, allergy, migraine, sinusitis, urticaria, atopic dermatitis, COPD, URI, influenza, and pneumonia. Our four Principal Investigators are Physicians board certified in Allergy and Immunology and they have each earned the designation of Certified Physician Investigator (CPI®) as determined by the Association of Pharmaceutical Physician Investigators (APPI).

Clinical research sites that wish to participate in clinical testing of Generic Drugs are required to self-identify with the FDA, pursuant to the Generic Drug User Fee Amendments of 2012 (GDUFA). Clinical Research Institute completed this certification in the first effective year and maintains its annual renewal each May. Sponsors may verify our annual renewal directly with the FDA at http://www.fda.gov/forindustry/userfees/genericdruguserfees/default.htm or you may contact us directly for our annual certification. This link also provides more specifics about GDUFA.

 Our Research Staff:

  • Principal Investigators
  • Research Manager
  • ACRP Certified Research Coordinators
  • Research Assistants
  • Regulatory Manager
  • Quality Assurance Manager
  • Marketing Manager
  • Recruitment Manager
  • Financial Manager

Our Facilities:

  • Fully-staffed and fully-equipped research facilities located in Downtown Minneapolis in the Medical Arts Building and in Plymouth at Abbott Northwestern/WestHealth.
  • Dedicated work stations to accomodate monitor visits, with access to a wireless connection.
  • Capability to easily accommodate extended patient stays up to 12 hours.
  • Capability to perform IV infusion studies.
  • Extensive experience with pulmonary function testing including bronchoprovocation studies (using exercise, histamine, methacholine, or antigen).
  • Access to expanded radiology services including CT scan and bone densitometry diagnostic studies.
  • Cold centrifuge available for laboratory sample processing
  • A  -20C freezer for storage.
  • A - 70C freezer for storage.
  • ECG equipment available on site.
  • Experience in ambulatory Holter monitoring.
  • Secured drug/device storage.
  • Pollen collection and Pollen counting performed by certified staff on site.
  • Ability to use central IRB services.
  • Our Downtown Minneapolis facility has close access to Hennepin County Medical Center (a Level 1 Trauma Center – 0.6 miles) or Abbott Northwestern Hospital (2 miles).
  • Our Plymouth Facility has access to North Memorial Hospital (a Level 1 Trauma Center - 8.6 miles) and Methodist Hospital (9.6 miles)
  • Crash cart, oxygen, emergency medications, defibrillator on site.
  • All staff are CPR certified.
  • 24-hour physician on-call for emergencies (612-338-3333)
  • CRI sites are self-Identified with the FDA in accordance with GDUFA (Generic Drug User Fee Amendments of 2012)

Access to Large Patient Population:

  • Access to over 6,000 patients via our research database.
  • Clinical Research Institute is affiliated with Allergy & Asthma Specialists, PA a large private medical practice of three Internists, three Pediatricians and a Nurse Practitioner who serve an active patient population of over 10,000 individuals treated for allergies, respiratory disorders and migraines.