SPONSORS

SPONSOR/CRO

Pivotal Clinical Research & Associates is a community that embraces research and innovation. Our patients are reliable and compliant. Our dedicated team actively recruits and educates our study volunteers. We have low screen fail rates and excellent retention as a result of careful subject selection and screening. Pivotal Clinical Research  & Associates is dedicated to the highest quality medical research. Pivotal Clinical Research & Associates has Phase II- IV capabilities and is located within the private practice, with a dedicated clinical research department which includes the following:

  • Access to a full range of diagnostic radiology testing such as, MRIs, Ultra-Sounds, DXA, ECG, EEG, and Mammogram testing.
  • Locked temperature monitored refrigerators and freezers on backup power for drug and specimen storage (including -20° C freezer for ultra-low specimen retention)
  • 24-hour surveillance security system
  • Standard and refrigerated centrifuges
  • Comfortable monitoring rooms for sponsor representatives which include high-speed internet access, copier and faxing capabilities, and private rooms to view study files.
  • All equipment is properly maintained and calibrated at least annually.
  • Total # of Active Patients in our Database:  5,185
  • Private Practice w/Dedicated Clinical Research Team
  • Bilingual Staff
  • Experienced Sub-Investigators:  2
  • Experienced Coordinators:  3
  • Recruitment Capabilities:  90% of our clinical trials have exceeded enrollment because we identify, pre-screen and recruit most of our patients from our database.  This process is initiated upon receiving notification from the CRO/Sponsor that we have been selected as a site to ensure successful enrollment
  • Cycle Time from Receipt of Contract to a Fully Executed Contract:  Within 10 business days
  • Cycle Time from IRB Submit to IRB Approval:  5 business days
  • SIV/Monitoring Visit Preparedness
  • All files/documents are set-up & available in the CRA’s designated room/office/area for 100% review during the conduct of his/her visit.  The Lead CRC and PI are available throughout the visit and a wrap-up review is conducted at the completion of the Monitor’s Visit.
Our study team has a proven track record of handling the multiple complexities required of various Clinical Trials.  We are qualified, experienced and have the patient population to successfully meet the needs of any protocol.


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