11.06.25 -- Regulatory Pathways For Successful CGT Clinical Trials

FSP partnerships are transforming clinical operations and delivering not only efficiency and scalability, but also the innovation needed to accelerate development and improve patient outcomes.

Targeted modalities are pushing the boundaries of therapeutic effectiveness. Their potential to transform patient care depends on leveraging the right expertise, technologies, and partnerships.

For sponsors eyeing Australia, CROs with deep local expertise unlock the region’s advantages and, coupled with a global outlook, can ensure your trial aligns with international regulatory expectations.

Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

Though some turnover is an inevitable part of a business’s life cycle, there are several strategies available to ensure a consistent CRO team throughout the span of your trial.

Vendor selection often fails due to five common dysfunctions. Identifying and addressing them early improves alignment, trust, and trial performance—avoiding costly delays.

When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.

A financial project analyst (FPA) plays a critical role in clinical trial supply and budget management. Explore how sponsors can benefit from having this specialist on their supply partner's team.

Learn how DTP clinical supply enables participants to receive treatments in the convenience and comfort of their own homes while reducing (or eliminating) the need to travel to a clinical site.

Integrated human ADME studies streamline the process from 14C synthesis to clinical conduct and final reporting to accelerate your drug development program.

Explore a bottling solution that is meticulously engineered to adhere to the most stringent pharmaceutical standards, which guarantees that each product is crafted with unparalleled quality and precision.

Bringing effective therapies to proof-of-concept and then to market as fast as possible is our passion because every second counts for patients with cancer and their families.

Move drug development into the modern era with a CRO that offers assay development and validation, bioanalytical testing, sample prep, and more.

With a focus on small and mid-sized biopharma companies, this premier CRO specializes in delivering innovative solutions in oncology and infectious diseases.

This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

The use of AI in pharmacovigilance can enhance processes such as data analysis, signal detection, and case management by increasing efficiency, accuracy, and the ability to manage large datasets.

Review details of the adoption of ICH GCP E6 R3 Principles and Annex 1, as well as what preparations and next steps your organization will need to undertake.

Historically regarded as the gold standard efficacy endpoint, Overall Survival (OS) in oncology trials is now positioned not only as a measure of therapeutic benefit but also as a critical safety endpoint.

The Clinical Trials Regulation and its centralized digital platform, the Clinical Trials Information System (CTIS), are now mandatory. Are you prepared to navigate your next clinical trial in the EU?

Explore ethical and regulatory challenges in neurological gene therapy trials, with expert insights on IRB/IBC collaboration, consent protocols, and oversight for vulnerable populations.

This regulatory operations team enables biotech and pharmaceutical companies to focus on innovation while ensuring a smooth, compliant path to market entry.