Infectious Disease CRO Services
In today’s volatile market for infectious disease R&D funding, it’s all about boosting efficiency to maximize your time on market after approval. The right partner makes all the difference.
Work with the CRO that delivered 50% of antibiotics to market since 2010
Infectious Disease Pivotal Trial Solutions
Bringing a novel infectious disease drug to market isn’t easy. Many conditions require rapid diagnostic testing and treatment in complex patient populations, including critical care and immunosuppressed subjects, so patient assessment during screening periods needs to move quickly. Meanwhile, varying lab capabilities require sites and sponsors to have a clear understanding of operational flow and patient pathways.
In the race to approval, not just any CRO will do. Your CRO needs the expertise to design a study in line with site and regional standards of care to minimize amendments and other potential delays. They need relationships with the most experienced, high-performing sites in the right countries, along with site support resources to help each site enroll more quickly. And most importantly, they need to deliver quality data.
With PSI’s steadfast commitment to on-time enrollment, more than 90% of our sponsors’ infectious disease studies, including large antibacterial and antifungal drug development programs, complete on time or ahead of schedule.
Recent PSI Infectious Disease Highlights
- 14 ID drug approvals
- 28,000 patients enrolled across 45 countries
- Consistent faster-than-industry enrollment in all ID studies
- ID-focused laboratory support services in all studies
- BARDA experience and relationships with qualified vendors
PSI is an antibiotic powerhouse. I will say this to anyone.
PSI Infectious Disease Therapeutic Expertise
Antibacterial
- Acute bacterial skin and skin structure infections
- Acute hematogenous osteomyelitis
- Bacteremia; bacterial infections
- Bone or joint infection due to Staphylococcus
- Chlamydia pneumoniae
- Clostridioides difficile
- Community acquired (bacterial) pneumonia
- Complicated intra-abdominal infections
- Hospital-acquired infections
- Nosocomial pneumonia
- Sepsis (antibiotic treatment)
- Staphylococcus aureus bacteremia
- Surgical site infections
- Urinary tract infection, complicated and uncomplicated
- Ventilator-associated pneumonia
Antifungal
- Candidemia and invasive candidiasis
- Invasive aspergillosis
- Invasive mold diseases
- Prophylaxis of invasive aspergillosis in lung transplant recipients
- Prophylaxis of invasive fungal diseases in allogeneic stem cell transplantation
- Prophylaxis of invasive mold diseases in leukemia
Other
- Non-antibiotic sepsis treatment
- Hepatitis B (HBV)
- Hepatitis C (HCV)
- Hepatitis D (HDV)
Specialized Infectious Disease Trial Support Services
Pragmatic Site Selection for On-time Enrollment
Tailored country selection is key to on-time enrollment in ID studies. PSI’s sponsors use enhanced GenAI-powered protocol similarity search and enrollment rate predictions in the VISIONAL™ feasibility/financial planning tool to identify the best country mix for their studies.
PSI’s SYNETIC™ site knowledge database expands these capabilities by combining our internal ID data with multiple external data sources to align high-potential sites with your protocol. With SYNETIC™, teams can make more informed decisions based on real-time monitoring of performance metrics, operational capacity, and patient recruitment potential for various indications.
Tailored Lab Strategy to Achieve Your mITT Goals
Selecting the right laboratory strategy – including deciding whether to use local or regional facilities, standardizing sample processing, and ensuring reliable microbiological confirmation to define eligibility for your Microbiological Modified Intent-to-Treat (micro-ITT) population – can make or break your pivotal infectious disease study. PSI’s Laboratory Support Services team helps ensure an efficient and cohesive lab strategy throughout the course of your study.
However, identifying the right labs isn’t enough — you need to know how to work with them as well. Sites often need support in managing newer and emerging diagnostic tests, including digital PCR and rapid antigen and protein-based platforms. The lab support team provides a dedicated resource to help you incorporate the best available technologies while streamlining communication with central labs. PSI treats local and regional labs as sites and suggests not only careful selection but also monitoring services during the course of the study.
Your Reliable Partner for Anti-infective and Anti-fungal Drug Development
Finding the right partner for infectious disease programs — a CRO large enough to support global trials while nimble enough to adapt to project-specific needs — is a challenge. When infectious disease sponsors want reliability and peace of mind, they choose PSI.
In addition to extensive antibacterial and antifungal therapeutic expertise, PSI provides support for managing the complexities of these studies, including negotiating contracts for BARDA-funded studies. SYNETIC™ provides you with insight into sites we know will accept this contracting language while — crucially — also enrolling well.
With more than a 93% repeat and referral business rate, PSI helps our sponsors deliver large programs in complicated infectious disease indications on time and on budget.
Connect with PSI’s infectious disease team
Streamline your ID trial with the CRO built for the challenge. Get in touch with our experts today.
Trusted to Deliver
When you partner with PSI, you work with a team recognized by independent industry organizations and sponsor surveys for what matters most in clinical research: expertise, consistent operational excellence, and reliable delivery.
Latest candidemia/invasive candidiasis research published in Clinical Infectious Diseases leading to drug approval