08.04.25 -- Navigating Cell And Gene Therapy Clinical Trials

Our experienced teams have helped clients with more than 480 oncology and hematology studies, prepared more than 70 INDs/CTAs, and have worked on more than 30 US and European regulatory marketing applications.

Our proprietary GlobalReady model covers the entire drug development journey from robust early phase clinical foundations with ClinicReady to seamless multi-regional late phase expansion.

Precision for Medicine is the first global, precision-medicine, biomarker-driven contract and clinical research organization, with expertise in today’s most advanced techniques for deeply interrogating samples to better understand patient biology.

MRN’s Site Network brings clinical trials closer to patients by engaging and empowering sites in the heart of their own communities. We increase access to diverse patient populations through the flexibility of our design.

The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence.

Gain analyses to support critical decisions in the development of a range of drugs. Our team is adept at performing non-compartmental analyses and population PK/PD analyses for all types of clinical studies, at all phases of drug development.

I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies.

Quest’s unique combination of industry-leading deidentified lab data, enhanced with claims, prescription (Rx), and EHR insights, allows pharma teams to refine targeting, optimize engagement, and drive better patient outcomes.

Novotech’s Regulatory Affairs team offers customized, end-to-end clinical and regulatory solutions, guiding biotech, pharma, and med device companies through the entire product lifecycle.