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.

PSI’s key differentiator is our ability to plan and execute complex clinical trials on time, saving our customers millions of development dollars.

Oncohematology Trials

Several dozen studies successfully completed across 40 countries Currently working with 250+ oncohematology sites worldwide Thousands of sites in North America, Latin America, Europe, and Asia Pacific Aced FDA inspections to PSI sites Contributed to several drug approvals in: Multiple Myeloma, Lymphoma and other related indications.

“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

The PSI Advantage

PSI CRO has received 2024 CRO Leadership Awards in the categories of Expertise, Quality, Compatibility, and Reliability in the Overall (combined Big and Small Pharma) respondent group. This is the seventh consecutive year that PSI has received leadership awards presented by Clinical Leader and Life Science Connect based on research conducted by ISR. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI wins CRO Leadership Awards for Expertise, Compatibility, Quality, and Reliability

Therapeutic areas

Inflammatory Bowel Diseases (IBD)

Crohns’ Disease, Ulcerative Colitis and other IBDs.


Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer and other Oncology indications.


Multiple Myeloma, Lymphomas, Leukemias and other oncohematological indications.

Infectious Diseases

Antimicrobial and Antifungal infections and other ID.

Multiple Sclerosis

Multiple Sclerosis, Spasticity and other neurological indications.

Rare Diseases

Hemophilia A & B, Von Willebrand Disease, Thrombocytopenia, Polycythemia Vera, Paroxysmal Nocturnal Hemoglobinuria (PNH).