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250+ hematology sites
around the world

The global leader in hemophilia & hematology studies

More than 50% of operational staff has hematology/oncohematology experience.

Excellent working relationships with KOLs globally
Current knowledge of enrollment rates and global competition

Hemophilia A & B Clinical Trials Experience

  • 40 phase I-IV studies conducted in 40+ countries
  • 700 sites overall in North America, Latin America, Europe, South Africa, Asia-Pacific, Japan
  • 1000 patients enrolled
  • Close collaboration and good relationship with sites, including KOLs globally
  • 7 FDA inspection and PMDA inspection to PSI sites resulting in drug approval
  • Extensive Gene Therapy experience

Braving Gene Therapy 

Gene therapy offers the promise of correcting genetic diseases by delivering a functional DNA copy, commonly using viral vectors. Of all the diseases out there, many biotechs have decided to focus their gene therapies in hemophilia.

PSI is one if not the only CRO that has been engaged extensively in gene therapy trials by half a dozen biotech sponsors.

The sheer numbers of innovative hemophilia treatments hint at a brighter future for patients in the next few years. In the words of Jan Hartmann and Stacy Croteau from Harvard Medical School, “hemophilia is now at the precipice of a therapeutic revolution.”

Revolutionary treatments require revolutionary CROs, intolerant of trial delays, accountable for study budgets, knowledgeable of regulatory landscapes throughout the world. Even more impor- tantly, the CRO must have developed tight and effective working relationships with hemophilia sites around the world. These rela- tionships must have stood the test of timely patient enrollment and many FDA inspections resulting in drug approvals.

We invite you to join us on a dedicated, complex and exciting journey to a better future of hemophilia patients.

 

 

 

 

Meet the global clinical research organization ranked No. 1.

“Thanks again to all the PSI teams that helped us in completing enrollment in our pivotal Phase III trials -- safe to say we could have never done it without PSI.” VP, Clinical Operations and Data Management

Your unfair advantage

Ranked #1 Global CRO by Investigators Worldwide

Ranked #1 Global CRO by Investigators
Worldwide. CenterWatch 2015-2017

Therapeutic areas

Other therapeutic areas of expertise