The Medpace Difference for Infectious Diseases and Vaccines Studies
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. 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
A specialized Data Integrity Unit is dedicated to collaborating with the clinical team and ensuring the protocol is maximally operationalized to collect appropriate microbiological, diagnostic, and biomarker data to evaluate study outcomes. The team will also liaise with local and central labs as well as provide real-time review of study diagnostic and laboratory data to monitor protocol testing and identify trends or issues. The Data Integrity Unit works closely in collaboration with the Medpace Data Management team, on case report form design and data cleaning to ensure the quality and scientific integrity of the data are satisfactory
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:
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
Working Together to Accelerate Clinical Development for Drugs, Vaccines, Diagnostics,
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. 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
Cellular and gene 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 continue to expand testing capabilities for SARS-CoV-2. To learn more about how we can support COVID-19 trials and our testing capabilities, click here.
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