We in the drug development industry—particularly those developing COVID-19 vaccines, diagnostics, and treatments—have the opportunity to turn the tide on this pandemic. We are excited to bring our significant expertise to bear in the fight to bring relief to those who are suffering. Rho offers the following services for COVID-19 development programs:

• Strategic guidance for accelerated regulatory product development
• Trial design, including statistical analysis
• Guidance for virtual and remote clinical site monitoring strategies
• 4 week database build* and centralized data monitoring and cleaning
• Expedited study start-up and patient recruitment
• Parallel development and writing of regulatory documents to enable rapid submissions
• Regulatory submissions management, including interfacing with FDA

*Shortening clinical database builds to 4-6 weeks is based on standard clinical trials with minimal customization and system integrations.

23+ years of industry-leading federal research experience

Through strong and ongoing relationships with the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Department of Health and Human Services (DHHS), and 1 of only 5 CROs chosen to be in the BARDA Medical Counter Measures (MCM) Clinical Studies Network, Rho continues to be called upon to assist the U.S. Government in the development of drugs, vaccines and diagnostics that help ensure public safety against the threat of pandemics, bioterrorism and emerging diseases.

Our interactions with BARDA over the last 6 years have given us a deep familiarity with the priorities, personnel, processes, and vendors that drive BARDA’s medical countermeasures research. The knowledge gained through our BARDA interactions means that we can offer quality support and guidance on BARDA’s preferences for study conduct. For example:

• We have extensive experience with vendors already approved by BARDA
• We have quality systems and project plans in place that have been approved by BARDA
• We understand that BARDA values cross-functional team integration (e.g. partnering with their CROs to attending monitoring visits and audits)

BARDA MCM studies awarded to Rho, include:

• Phase 2 Panblok® H7 Influenza Vaccine at Three Dose Levels Adjuvanted with AS03 or MF59 Vaccine Trial
• Phase 2 Safety and Immunogenicity of Anthrax Vaccine in Individuals over 65
• Phase 1 Randomized, Three-Way Crossover Study to Assess the Bioavailability and Pharmacokinetics of a Single Dose of Atropine Administered Sublingually in Healthy Adult Volunteers

Conducting research during the 2009 H1N1 pandemic

During the 2009 H1N1 pandemic, the NIH turned to Rho to rapidly develop and coordinate a national, multisite research project to evaluate the immunogenicity and dosing of the H1N1 vaccine in those with asthma. Rho supported the trial from protocol development through publication of study results.

In less than 18 months, the study team went from the initial study idea to publication of the primary study results in the Journal of Allergy and Clinical Immunology. Read the case study.

Current COVID-19 Clinical Trial Support

Currently, our experts are conducting clinical trials for COVID-related products, including a 6,000 patient study of Coronavirus infection rates in children, which is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This study is breaking new ground in the conduct of virtual trials by allowing patients to complete the study almost entirely from home, including the self-collection of nasal swab, blood, and stool samples.

Additionally, since the pandemic began, Rho has worked with many sponsors to provide trial and site selection strategies in support of their planned COVID-19 treatment and vaccine studies. This includes extensive site feasibility to determine COVID-19 infection rates at the state and county level, PPE availability and needs at the site level, and determining the geographic location of the highest bolus of subjects, based on projected outbreak forecasts of 4-8 weeks out.