Infectious Disease & Vaccines
He feared the influenza pandemic would steal time with his granddaughter.
They just perfected their chocolate chip cookie recipe.
That is what drives us. Experience, Rho.
Now more than ever, as global pandemics such as COVID-19 and other infectious diseases threaten people’s lives across the globe, demanding an adaptable CRO partner with Medical Counter Measures expertise and a track record of delivering relief when and where it’s needed isn’t just important – it’s critical.
Passionately fighting to protect the health of our nation since 1997, Rho has conducted more than 175 infectious disease studies at 300+ sites and over 100,000 patients. With virtual trial experience and vast infectious disease expertise extending from program strategy through clinical trials and marketing applications, as well as long-standing relationships with NIH, NIAID, and BARDA, Rho possesses a distinct advantage when navigating the challenges common to this therapeutic area, including decentralization and those related to safety and labs, at-risk populations, compliance, genotype/phenotype vendors, and retention.
Infectious Disease & Vaccines Expertise
Why Choose Rho?
2 recent NDA submissions to CDER Division of Anti-Infective Products
1 of 5 CROs chosen for the BARDA Medical Counter Measures Clinical Studies Network (CSN)
Awarded Statistical, Data and Clinical Coordinating Center by the National Institutes of Allergy and Infectious Disease (NIAID)
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
If you’re looking to acquire BARDA funding for your clinical trial or program, our experts can provide strategic guidance to help set you up for success.Learn more about our BARDA funding consulting services
As the Clinical Trial Manager for a Sponsor Organization, I have had the distinct privilege of working with Rho. I continue to be impressed with the support we receive from Rho, especially in light of the COVID-19 pandemic. The pandemic presented us with challenges leading to modifications to our ongoing protocol-specified procedures. However, with the implementation of pragmatic design aspects focused on data integrity and the safety monitoring of our patients, we were able to continue our trial without interruption.
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.
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.
Kevin Barber, Ph.D.
Vice President, Regulatory Strategy & Submissions
Jamie Chang, M.D.
Gloria David, Ph.D., M.H.Sc
Principal Research Scientist
Marina Acosta Enslen
Associate Director, Clinical Management
Principal Clinical Data Manager
Bill Barry, Ph.D.
Senior Research Scientist
Senior Project Manager
Clinical Project Manager / Epidemiologist / Clinical Team Lead
Theresa Scocca, Ph.D.
Clinical Team Lead
Infectious Disease and Vaccine Services
Consulting: Acquiring BARDA Funding
Risk-Based Quality Management
Clinical Project Management
Clinical Monitoring and Operations
Clinical Data Management
Randomization and Trial Supply Management