Enhancing the Success of Your Infectious Diseases Clinical Trial
Finding effective treatments and vaccines for viral, bacterial, and fungal infections is vital for improving global health. The complex, dynamic nature of infectious diseases demands a thorough medical understanding of numerous indications and the ability to assimilate the issues surrounding the geography, epidemiology, and prevalence of the disease to successfully conduct global infectious diseases clinical trials. Achieve quality results, meet deadlines, and maximize efficiencies by partnering with a full-service clinical research organization (CRO) that excels in the design and execution of clinical trials in antivirals, antibacterials, antifungals, vaccines, and immunotherapies. Our experienced medical leadership in infectious diseases, specialized cross-functional teams, integrated laboratories, and extensive site and investigator relationships produce a truly seamless drug development process that can accelerate your path to approval.
Making the Complex Seamless® in Global Infectious Diseases Clinical Development
Maximize your compound’s probability of success by leveraging our extensive experience in the design and conduct of global Phase I-IV infectious diseases clinical trials. Sponsors from emerging biotechs to global pharmaceutical companies have trusted Medpace for over 30 years to lead their infectious diseases development across indications spanning adult and pediatric patients, as well as special at-risk populations.
Infectious Diseases CRO Capabilities
Our cross-functional collaborative model and extensive global infectious diseases clinical trial experience allow our team of experts to support your development across all regions by:
- Assisting with securing government and non-dilutive funding such as BARDA, NIH, and Wellcome-Trust
- 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
Integrated Central Laboratory
Lab requirements for global infectious diseases clinical development can be challenging. Medpace provides global central laboratory services to support global infectious diseases trials and coordinates the complex logistics with specialty testing labs. The Medpace global central lab model, coupled with our partnerships with specialty microbiology laboratories in strategic geographies, gives sponsors a competitive advantage:
- Highly specialized research scientists focused on delivering quality data to meet tight timelines demanded in ID trials
- Simplify logistics and gain efficiency – Medpace central labs coordinate shipping between sites and labs around the world
- Specialty microbiology labs integrate seamlessly with our global central laboratory network and full-service approach to clinical trial management
- A global network of central laboratories that work collaboratively with top microbiology and virology labs, including International Health Management Associates (IHMA), 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 documented processes and systems to ensure the quality and scientific integrity of study data, your trial could be at risk of significant delay – and millions in added cost. The Medpace Data Integrity Unit is a team of microbiology specialists. This dedicated team collaborates with the clinical operations team to ensure the protocol is maximally operationalized to collect appropriate microbiology, virology, diagnostic, and biomarker data to evaluate study outcomes. The team will also liaise with local and central laboratories and 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 for each study. Monitoring study data on an ongoing basis allows the Data Integrity Unit to quickly identify study trends and proactively take steps to mitigate issues before they negatively impact the quality of the study data.
Strong Long-Standing Relationships
Our strong relationships with investigators, key sites, regulators, institutions, specialized laboratories, and KOLs in infectious diseases help facilitate strategic site selection, start-up, and recruitment efforts. The experience and expertise combined with long-standing relationships will readily translate into the successful and timely recruitment, conduct, and delivery of a study.
Infectious Diseases Clinical Trial Experts
The Medpace interdepartmental, multidisciplinary approach leverages the experience of colleagues across functional and therapeutic focus areas to pool our collective knowledge to support your 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 are often consistent from project initiation to completion and on to the Sponsor’s next project, adding continuity and efficiency to your study.
Our thorough medical, operational, and regulatory understanding of the complexities of infectious diseases trials allows us to identify potential pitfalls early and implement strategies to avoid them, helping to minimize risk and accelerate bringing new therapies to market.
Related Infectious Diseases Insights
Learn how we can support COVID-19 trials and our testing capabilities