Medpace has Extensive Expertise to Enhance the Success of Your Infectious Diseases & Vaccines Clinical Trial
Developing effective treatments and vaccines for viral, bacterial, and fungal infections is vital to improving global health. The complex and dynamic nature of infectious diseases requires deep medical expertise across numerous indications, as well as a comprehensive understanding of disease epidemiology, geographic variability, and prevalence to successfully execute global trials. Achieve quality results, accelerate timelines, and maximize efficiency by partnering with a full-service clinical research organization (CRO) with extensive experience in the design and execution of clinical trials across:
- Antivirals
- Antibacterials
- Antifungals
- Antiparasitics
- Vaccines
- Immunotherapies
Why Sponsors Choose Medpace for Infectious Diseases & Vaccines Trials
Sponsors from emerging biotechs to global pharmaceutical companies have trusted Medpace for over 30 years to lead their infectious diseases and vaccine (ID&V) development across indications spanning adult and pediatric patients, as well as special at-risk populations. Mepdace’s experienced medical leadership, specialized cross-functional teams, integrated central laboratories and microbiology expertise, and extensive site and investigator relationships produce a truly seamless drug development process that can accelerate your path to approval.
In the past 9 years, Medpace ID&V experts have contributed to:
Hear from our Sponsors
“Macro Biologics is a small company working at the interface of biotechnology and materials science to develop novel products to prevent and treat life-threatening infections. Medpace has been an exceptional partner to us, providing us with thoughtful advice and practical support from early in our nonclinical work through IND preparations and into clinical trials. Their expertise in infectious disease and their skills in document development and project management have been invaluable to us. We anticipate a long and productive working relationship.”
– Michael P. Bevilacqua, M.D., Ph.D.
Chief Executive Officer, Chief Science Officer
Macro Biologics, Inc.
Making the Complex Seamless® in Global ID&V Clinical Development
Maximize your compound’s probability of success by leveraging our extensive experience in the design and conduct of global Phase I-IV ID&V clinical trials.
Infectious Diseases CRO Services
Medpace’s cross-functional, collaborative model and extensive global infectious diseases clinical trial experience enable our experts to support your global development program by:
- Assisting with securing government and non-dilutive funding such as BARDA, NIH, Wellcome-Trust, Department of Defense (DoD), and CARB-X
- Offering comprehensive support via our dedicated global regulatory submissions and global regulatory affairs teams
- Accelerating your program by quickly mobilizing and enrolling for acute diseases and during peak seasons
- Guiding small to mid-size biotechs via early engagement to provide regulatory gap analysis, a referral to a KOL, a support group, or a specialty lab
Vaccine Clinical Development Expertise
Vaccine development is essential to preventing high-risk diseases but presents unique challenges, including fast-paced enrollment, the epidemiology of emerging and resistant pathogens, and evolving technological advancements. Backed by global experience and scientific expertise, the Medpace ID&V team supports vaccine clinical trials across a broad range of vaccine types and patient populations through:
- Medpace ClinTrak®, a seamless systems integration, providing real-time access to all patient and study data, perfect for rapidly enrolling fast-paced vaccine trials
- A collaborative team of medical and operational experts with extensive vaccine experience to ensure trial efficiency and seamless execution
- A regulatory affairs team with an extensive insight of the regulatory landscape and challenges of vaccine development globally
- A CRO partner that is dedicated to the small to mid-sized biotech market. Having 90% of our client base in this market, Medpace understands the complex challenges that emerging biotechs face
- Medpace’s organic growth provides Sponsors consistency in leadership, deep institutional experience, and incomparable efficiencies and stability
- Broad vaccine expertise across indications, including but not limited to:
- COVID-19
- Dengue
- Ebola
- Gram-Negative Infections
- Hepatitis-B
- Herpes Simplex Virus (HSV)
- Human Papillomavirus (HPV)
- Influenza
- Malaria
- Measles, Mumps, and Rubella (MMR)
- Pneumococcal
- Respiratory Syncytial Virus (RSV)
- Shingles
- West Nile Virus
Integrated Central Laboratories
Lab requirements for global ID&V clinical development can be challenging. Medpace provides global central lab services to support global ID&V trials and coordinates the complex logistics with specialty testing labs. The Medpace global central lab model, coupled with our partnerships with specialty microbiology labs in strategic geographies, gives Sponsors a competitive advantage:
- Highly specialized research scientists focused on delivering quality data to meet tight timelines demanded in ID&V trials
- Streamlined logistics and increased efficiency – Medpace central labs coordinate shipping between sites and labs around the world
- Specialty microbiology labs integrate seamlessly with our global central lab network and full-service approach to clinical trial management
- A global network of central labs that work collaboratively with top microbiology and virology labs to provide the specific testing required for each study to streamline timelines, simplify requirements for sites, and provide a centralized model for communication
Specialized Data Integrity Unit
Without the right processes and systems to ensure the quality and scientific integrity of study data, your trial could be at risk of significant delay. The Medpace Data Integrity Unit—a team of microbiology specialists—partners closely with clinical operations to ensure protocols are operationalized for the collection of high-quality microbiology, virology, diagnostic, and biomarker data to evaluate study outcomes. The team also liaises with local and central labs and provides real-time review of 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, data cleaning, and ongoing data review to help ensure the quality and scientific integrity of study data. By monitoring study data on an ongoing basis, the team can quickly identify study trends and implement corrective actions before they impact study quality.
Strong Long-Standing Relationships
Our strong relationships with investigators, key sites, regulators, institutions, specialized laboratories, and KOLs in ID&V help facilitate strategic site selection, start-up, and recruitment efforts. Medpace’s experience and expertise combined with long-standing relationships will readily translate into the successful and timely recruitment, conduct, and delivery of a study.
Established Global ID&V Network
Strengthened by collaborative partnerships with top-performing sites, Medpace offers Sponsors access to a global network of trusted sites. With a deeply embedded global footprint, this network has proven experience delivering rapid study start-up, high-quality data, and reliable high enrollment.
ID&V Clinical Trial Experts
The Medpace interdepartmental, multidisciplinary approach brings together experts across functional and therapeutic areas to leverage collective experience and support every stage of your development program. Studies are assigned the best-fit medical, operational, and regulatory experts from the onset. With turnover rates that are lower than the industry standard, teams remain consistent from project initiation to completion and often continue supporting subsequent projects, adding continuity and efficiency to your study.
Our thorough medical, operational, and regulatory understanding of the complexities of ID&V trials enables us to identify potential pitfalls early and implement proactive strategies to minimize risk and accelerate the development of new therapies.
Related Infectious Diseases & Vaccines Insights
Whitepaper
Considerations for Infectious Diseases Clinical Trials in At-Risk Populations
Article
Overcoming Challenges in Vaccine Clinical Development
Strategies for Success in the Evolving Landscape