An antibiotic powerhouse
Phase II & III studies
8 out of 12 novel antibiotics approved by the FDA since 2010 used pivotal clinical data generated by PSI sites
PSI’s high-functioning global network of microbiology labs offers high standard for sample testing and flexible logistics. Importantly, it allows obtaining microbiology data of superior quality.
Micro labs are isolating more pathogens than standard ordinary local labs, thus increasing the number of isolated strains in CABP studies from a standard 25% to 40% and up to 95% in ABSSSI.
This helps sponsors achieve desired mITT population rates and regulatory compliance.
Indications
- Candidemia
- Invasive candidiasis
- Invasive aspergillosis
- Acute bacterial skin and skin structure infections
- Acute hematogenous osteomyelitis
- Bacteremia; bacterial infections
- Bone or joint infection due to Staphylococcus
- Community acquired(bacterial) pneumonia
- Complicated intra-abdominal infections
- (Complicated) staphylococcus aureus bacteremia
- Nosocomial pneumonia
- Sepsis
- Urinary tract infection, complicated and uncomplicated
- Ventilator-associated pneumonia
- Surgical site infections
PSI’s key differentiator is our ability to plan and execute complex clinical trials on time, saving our customers millions of development dollars.
These days, if a CRO offers to run a global antibiotic clinical trial without presenting a network of qualified and trained microbiology labs, the sponsor should be suspicious.
These days, if sponsors don’t see clear metrics from a CRO on isolates identification rates in, lets’s say, CABP or ABSSSI compared to standard routine rates of isolate identification by microbiology labs, the sponsor should be suspicious.
These days, if sponsors don’t receive straightforward examples of consistent on-time delivery of antibiotic trials, with references from fellow sponsors, they should be suspicious.
How many months of enrollment were assumed from FPI to LPI in previous studies in the discussed indication? What actually happened? That timeline should be similar, with a deviation of no more than 10% in both directions. Consistently, time after time.
How many sites were initiated and how many remained inactive, per region?
“PSI is an antibiotic powerhouse. I will say this to anyone.”
VP Clinical Operations and Data Management
The PSI Advantage
Therapeutic areas
Oncology
Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer and other Oncology indications.
Hematology
Multiple Myeloma, Lymphomas, Leukemias and other oncohematological indications.
Rare Diseases
Hemophilia A & B, Von Willebrand Disease, Thrombocytopenia, Polycythemia Vera, Paroxysmal Nocturnal Hemoglobinuria (PNH).