Hematology Clinical Trial Expertise

Finding cures and treatments for blood diseases, genetic disorders, and cancers is complicated

Millions of people are affected by blood disorders each year.   While treatments continue to advance, the field of hematology grows increasingly complicated.  Whether the blood disease is genetic or acquired, whether it has invaded the blood cells, platelets, bone marrow, vascular endothelium, or plasma proteins, our team of scientific-minded experts are equipped to help bring your hematology therapies to market.

Overcoming Clinical Trial Challenges for Blood Disease

Veristat has guided clients through the conduct of more than 220 clinical trials and over 25 marketing applications for blood diseases. Our experience spans clinical development consulting, full clinical trial oversight, and regulatory submission preparation for rare genetic blood disorders and autoimmune blood diseases, as well as blood cancers.

At Veristat, our experienced teams are poised to plan and implement these efforts quickly providing:     

  • Development of regulatory strategy and agency communications 
  • Program Planning, inclusive of statistical planning and analysis 
  • Agile patient recruitment and recruitment
  • Rapid deployment of clinical trial databases  
  • Virtual and remote clinical and medical monitoring 
  • Data analysis, migration, and writing of regulatory documents 
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Our Malignant & Non-Malignant Blood Disease Expertise

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FDA Approval - The True Proof of Success

Veristat supports the first targeted therapy for adult patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 mutation.

"I have personally had the priviledge to work with a dedicated Agios team on the IND application, phase I study, and NDA submission for ivosidenib. I am thrilled to see TIBSOVO® receive FDA approval and look forward to seeing this therapy help improve the lives of patients with R/R AML."

Barbara Balser, VMD, Veristat Executive VP & Chief Scientific Officer


Learn More with These Resources

Case Study
Keeping Up with an Over-Performing Site Case Study

Find out how Veristat was able to expertly rescue the site management and monitoring activities for a  sponsor seven months into patient enrollment at the ...

Fact Sheet
Hematology Fact Sheet

Veristat's hematology experience spans clinical development consulting, full clinical trial oversight, and regulatory submission preparation for rare genetic ...

White Paper
Successful Preparation Strategies for  NDA/MAA Marketing ...

No two new drug applications (NDAs) or marketing authorization applications (MAAs) are the same. With each submission come special constraints, unique partnership ...


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