RSV Vaccine with PBMC Sampling – Rapid Medical Research, Cleveland OH

Home / RSV Vaccine with PBMC Sampling – Rapid Medical Research, Cleveland OH

CASE STUDY

Objective:

A pharmaceutical company needed experienced quality research sites in the US for their RSV vaccine study in patients aged 55 and older with PBMC sampling.

Solution:

  • Rapid Medical Research (RMR) has conducted over 55 vaccine trials including 25 of those in the 50+ age group.
  • RMR submitted feasibility within 24 hours and contract and budget response was completed within 5 days.
  • RMR obtained Biosafety Level 1 plus Standard Precautions Certification with WCG IRB Institutional Biosafety Committee Services.
  • For this cutting-edge vaccine trial, we exceeded our target enrollment number within 6 weeks.
  • We processed 2808 PBMC samples for this trial with our contracted laboratory-Cellular Technology Limited (CTL) which is located within 3 miles of our site.
  • 90% of patients enrolled were from our database and 10% from referrals and advertising

About Rapid Medical Research:

Our Site:

We have 8 patient exam rooms and 6 private monitor areas. We have fingerprint only,limited access, temperature-controlled IP storage facilities.  In addition, we have pharmaceutical refrigerators and freezers that are monitored 24/7 for temperature and are connected to a back-up generator ensuring temperature continuity in the event of power loss. We have extensive experience with collecting nasopharyngeal swabs from patients and providing weekly follow up phone calls to assess AE’s.

Our Staff:

We have 9 full time Study Coordinators with an average of 9 years clinical research experience at the site that are all certified by ACRP and have extensive clinical trial experience in vaccine trials.  We have processes in place to run vaccine trials efficiently and with the highest degree of quality.  Our staff also includes experienced unblinded coordinators with research experience and a background of BSN, RN & LPN.

We maintain high retention rates averaging 95% for vaccine trials by creating good relationships with our patients and providing continuous follow up.  Our average employment of 9.5 years helps to ensure that our participants are comfortable with our staff and return for subsequent participation.

Our three full time dedicated Patient Recruiters are experienced in recruiting for vaccine trials from our database of 25,000 patients.  Approximately 90% of our patients for vaccine trials come directly from our database. In addition, we have full time staff in the areas of Quality Assurance, Regulatory Submission & Compliance and Data Entry.  We provide 100% quality control for our consents and source documents and ensure that data is entered within 24-48 hours for vaccine trials.