The intricacies of immunomodulation in clinical trials can be complex, but our latest issue of The Altascientist breaks them down for you.

In this issue, discover:

• The standard classes of immunomodulators and their roles in clinical trials.
• Insights into the cutting-edge bioanalytical techniques for quantifying immunomodulators and their associated biomarkers.
• Two case studies with practical tips for ensuring quality outcomes that inform PK, PD, and safety.

Whether you are dealing with PK/PD studies or assessing safety in your trials, we provide you with the insights and strategies to achieve reliable and actionable results.

You may also be interested in the following webpage:

• Bioanalytical Services
• Clinical Services
• Preclinical Services

The True Meaning of Moving in Unison

We value your time as much as you do. At Altasciences, we break down organizational silos, streamline project management, and promote effortless communication to provide you with exceptional value.

From preclinical studies to clinical trials, and from regulatory submissions to tackling operational challenges, we are dedicated to safely accelerating your journey from lead candidate selection to proof of concept and beyond using a seamless and integrated approach to drug development.

Let's get your project started! Speak with an expert today.

Knowledge of potential drug-drug interactions (DDIs) is important in risk reduction, continued optimal delivery of patient care, and maximization of commercial success of your molecule’s journey.

Altasciences is well-versed in designing, conducting, and reporting on stand-alone studies for each inhibitor or substrate, as well as cocktail studies to assess interactions of multiple CYP enzymes or transporters in a single study.

Clinical Operation Highlights

• Expertise and Efficiency: Our sizeable patient database includes poor and extensive metabolizers of various CYP enzymes, complemented by historical genotyping data for rapid recruitment. We typically achieve First Subject First Visit (FSFV) in approximately 10 weeks from the final protocol.
• Skilled Clinical Operations: Our clinical operations staff are experts at managing participant safety, and are accustomed to managing the fast pace of DDI studies, expertly handling 60+ patients simultaneously.
• Comprehensive Support: Our Data Analysis, Medical Writing, and Scientific Affairs teams provide full-service, customized insights, including study design, rapid database development, biostatistics, and PK analysis, as well as executive summary analysis and detailed clinical study reports.
• Guidance on Follow-Up Studies: Should significant interactions be seen with the strong inducers or inhibitors, we will work with you to design follow-up studies with weak inhibitors and offer guidance for dosing adjustments.

You may also be interested in the following resources:

• Fact Sheet: Drug-Drug Interaction Clinical Trials
• Case Study: Drug-Drug Interaction Study on a Novel Cardiovascular Medication