Clinical Trial Services & Solutions Sourcing Center
According to the Alliance of Regenerative Medicine, there were 1,220 clinical trials ongoing at the end of 2020, with 152 of those trials in Phase 3, supporting the FDA's and EMA's predictions they will approve 10-20 cell and gene therapies each year by 2025.
The development of cell and gene therapy trials is both complex and challenging as well as subject to heavy regulatory scrutiny. As new and emerging biotechs and even established pharma drive their research forward through clinical trials, anticipating challenges can be key to bringing therapies from bench to bedside. Biotechs will be faced with important decisions when it comes to clinical development and selecting the right CRO partner is one of those decisions.
How can we help?
Looking for help with your Cell & Gene Therapy clinical trial? If you're searching for information or a supplier, let Life Science Connect lend you a hand.
When therapeutic product, viral capsid, or other vector elements may be culprits in gene therapy-induced toxicity, exploring activation or silencing of gene expression may help to guide vector design and construction to balance therapeutic efficacy against potential toxicity. Explore the importance of reproducible quantitation of gene expression to investigate potential sources of vector-induced immunotoxicity and understand well-to-well and instrument-to-instrument data concordance across multiple biosystems.
inSeption distinguishes people as the most impactful variable in the outsourcing equation. Our path-breaking model attracts biopharma companies who demand a partner that shares in their drive to conduct impeccable development and will provide quality and dependable clinical solutions. We offer full outsourcing, consulting services, and functional service provider (FSP) solutions.
Novotech is internationally recognized as the leading Asia Pacific-centered Biotech CRO with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services, and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US, and Europe.
Precision ADVANCE is a collection of interconnected services and complementary teams uniquely focus on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market. Learn more about how we accelerate clinical development with Precision for Medicine, optimize next-gen manufacturing with Project Farma and drive commercial success with Precision Value & Health.
Premier Research believes in a holistic approach to clinical development. From regulatory consulting, to product development, to innovative study designs and patient-centric solutions, we consider your study from every angle to maximize success. Our Built for Biotech℠ model is rooted in flexibility, and we are dedicated to helping the most innovative biotech, specialty pharma and medtech companies take their best ideas from concept to commercialization.
Synthego is a genome engineering company that enables life science research and therapy development with a mission of increased access to engineered therapies for all patients. With unparalleled CRISPR expertise, state-of-the-art GMP capabilities, and a continuum of product offerings, Synthego supports CRISPR-edited cell and gene therapeutic development at every step, from R&D through IND submission to first-in-human trials.
Veristat, a global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 26 years' experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared over 100 marketing applications for approval with global regulatory authorities in the last 10 years alone.