Insights on Clinical Trials

  1. Cell And Gene Therapy Team Guides Troubled Rare Disease Programs To Success 11/2/2020

    A clinical-stage biotechnology start-up asked Veristat to run a new European trial of their complex gene therapy. Veristat experts complimented the client’s team taking on their first clinical-stage program. Our global cell and gene therapy team brought knowledge in genetic material handling, relationships with key global regulatory agencies, and expertise in accelerated pathways to approval.

  2. Stem Cell Therapy For Stroke Patients 11/2/2020

    A client engaged the Veristat team in a Phase II study of intracerebral stem cell injection in patients following an ischemic stroke. The goal was to look at limb recovery time and level in patients with stroke. The effort began with identifying the best time for a product to be delivered and then expanded into full-service involvement, including project management, clinical monitoring, medical writing, and regulatory affairs. Learn how we overcame unique challenges in this multi-center trial that led to the client publishing positive Phase IIa data.

  3. Full Service Support For A Gene Therapy Trial 11/2/2020

    A clinical-stage biotechnology start-up asked Veristat to run complex US and EU trials of their unique gene therapy. Veristat brought invaluable global capabilities and expertise to a small client team tackling their first clinical-stage program without the large infrastructure or resources to conduct studies in this space themselves. Our end-to-end support started at Phase I and will continue into post-marketing and regulatory follow-up.

  4. Case Study: Reduced Risk, Spending, And Work In A Global Diabetes Trial 10/29/2020

    And as one leading multi-national pharmaceutical company recently learned, managing ancillary materials can be a challenge every bit as complex as the trial itself.

  5. 5 Tips To Avoid An IND Clinical Hold: Regulatory Guidance And Insights 10/19/2020

    A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them.

  6. Lessons Learned When Implementing A Risk Management Program 10/14/2020

    The design and implementation of risk management programs can be challenging. This white paper uncovers key lessons learned from our experience with over 120 RiskMAPs and REMS programs - which spans various therapeutic areas and targeted risks.

  7. Genetically Engineering An IL-15 Superagonist 9/29/2020

    SOTIO’s genetically-engineered SO-C101 is showing promise as a monotherapy and combined with immunotherapies in pre-clinical tests and also recently in a phase I study. CBO Jens Hennecke, Ph.D. shared an update on the company’s Phase 1 Progress. 

  8. Does RNAi Have A Future Beyond Liver Disease? 9/4/2020

    On the heels of his company's RNA interference IP buying spree, Arrowhead Pharmaceuticals CEO Dr. Christopher Anzalone seeks to prove the merits of RNAi in diseases beyond the liver.

  9. How Technology Is Enabling Advancements In The Assessment Of Patient Safety 8/5/2020

    Pharmacovigilance (PV) activities must be carefully planned from the outset of the drug development process. Read more about available process automation solutions available and if your company could benefit from working with external partners to manage PV activities.

  10. A Global Observational Registry Of Adult Patients With Homozygous Familial Hypercholesterolemia (HoFH) 8/5/2020

    Clinical development service provider efficiently and strategically manages a global rare disease registry with rolling start-up, including mandated annual data collection and reporting.