Infectious Diseases and Vaccines

COVID-19 Pandemic

Working Together to Accelerate Clinical Development for Drugs, Vaccines, Diagnostics, and Devices

To reiterate the message from our CEO, August J. Troendle, Medpace is committed to assist in the fight against COVID-19, which aligns with our mission of accelerating the global development of safe and effective medical therapeutics.

Medpace has a highly-experienced infectious disease team, including medical, regulatory, operational, and laboratory experts who have extensive experience designing and conducting infectious disease clinical trials. Our team is actively working with the global regulatory authorities and Sponsors responding to the COVID-19 situation.

If you are developing treatments for COVID-19 and need assistance, Medpace is well-equipped to assist:

• Speed: Our proven flat operating model and our multi-disciplined approach are designed for efficiency. We are well-equipped to move quickly and have taken steps to accelerate contracting and site-startup
• Site and investigator relationships: We are able to leverage strong relationships to quickly assess feasibility, accelerate enrollment and move trials forward
• Regulatory engagement: Knowledgeable in the changing regulatory landscape at local, regional, and global levels. Our team can provide regulatory support and strategy
• Remote monitoring tools and technology: Our processes and technology platforms enable remote monitoring and fast data acquisition. We support both sites and patients with portals for accessing and recording data that is easily accessible. We can support alternative methods for safety assessment, including phone contacts and virtual visits
• Government and research agencies: Our experience and relationships allow us to collaborate with government agencies and other research institutions, such as BARDA, NIH, and Wellcome-Trust
• Critically ill patients: We have extensive experience in acute care settings with critically ill patients, spanning pediatric to geriatric patients
• Advanced therapies: Extensive experience working with Sponsors to overcome development challenges and accelerate cutting-edge technologies including cell and gene therapies
• Testing: Medpace’s central laboratories currently have the ability to test for COVID-19 via an FDA-approved RT-PCR assay in our US laboratory and will have the assay available in our Europe laboratory very soon

Supporting Antiviral, Antibacterial, Antifungal and Vaccine Clinical Research

Achieve quality results, meet deadlines, and maximize efficiencies by partnering with a full-service CRO that excels in designing and executing clinical research in antivirals, antibacterials, antifungals and vaccines. As a global CRO with a therapeutic focus on infectious diseases and vaccines, we:

• Creatively approach novel compounds and delivery mechanisms
• Quickly mobilize and enroll for acute diseases and during peak seasons
• Anticipate challenges and proactively navigate rapidly evolving regulations, operational complexities and tight timelines

Infectious Diseases and Vaccines Experience

Extensive experience gives our medical, regulatory, and operational staff a thorough understanding of the complexities of ID trials from the perspectives of all the stakeholders involved in developing treatments for new and re-emerging infectious diseases:

• Broad experience designing and conducting global Phase I-IV clinical trials in antivirals, antibacterials, antifungals and vaccines
• Spans adult and pediatric populations
• Assist sponsors with securing government and non-dilutive funding such as BARDA, NIH, and Wellcome-Trust

Central Laboratory and Specialty Lab Support

Medpace provides central laboratory services to support global trials and coordinates the often complex logistics with global specialty testing labs. We work collaboratively with top labs in microbiology and virology to provide the specific testing required for each study. This approach streamlines timelines, simplifies requirements for sites, and provides a centralized model for communication.

Medpace’s lab relationships plus central lab model gives sponsors a competitive advantage:

• Access to top research scientists who are therapeutically focused in infectious disease, deliver regulatory-quality reports and meet the tight timelines demanded in ID trials
• With Medpace central labs coordinating the shipping between sites and labs around the world, logistics are greatly simplified, resulting in higher efficiency
• Specialty labs integrate seamlessly with Medpace’s full-service approach to clinical trial management

The Medpace Difference for Infectious Diseases and Vaccines Studies

Infectious disease and vaccine clients benefit from partnering with Medpace in numerous ways:

• Board-certified infectious disease physicians with backgrounds in academic hospitals, pharmaceutical companies and public health organizations. As published thought leaders, they regularly review articles for scientific journals, speak at industry events and consult with academic institutions and pharmaceutical companies
• Insight into evolving regulations through our ongoing interactions with FDA’s anti-infective division and participation in sponsor meetings with regulatory agencies
• Collaborative work and insights from strategic specialty labs, recognized as some of the top leaders in microbiology, virology, and PK-PD modeling