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Five criteria to use when selecting a CRO for a gene therapy study

QPS
9 Jan 2023

With cell and gene therapies (CGT) quickly making their way from theory to clinical practice, many biopharmaceutical companies are looking for CRO partners with significant experience conducting CGT-focused clinical studies. In this white paper, QPS describes five criteria to consider when evaluating organizations.

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QPS Clinical Phase I/IIa Development Services

QPS

Moving quickly and safely through Phase I/IIa trials is critical to successful drug development.  The QPS Phase I research facilities feature more than 550 beds across six strategically located facilities on three continents. QPS is well known for its success in first-in-human clinical trials. All Phase I sites are staffed by expert clinical pharmacology teams that routinely conduct hundreds of phase I/IIa studies annually. 

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QPS Global Regulatory Affairs Services

QPS

QPS Global Custom-Built Regulatory Services Can Transform Clinical Trials.  QPS Global Regulatory Affairs (GRA) service offerings focus on helping pharmaceutical, biotechnology, and medical device companies to develop custom-built research solutions that forge expedited regulatory pathways from discovery to global commercialization and onwards through product lifecycle support. 

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Combinatorial ChemistryCombinatorial chemistry, also known as combichem, is a technique used in drug discovery to create libraries of structurally related compounds. A library is generated by synthesis with a chemical reactor system or by computer-based modeling of compound combinations. When undertaking combinatorial chemistry consider reagents, buffers, resins and standards.Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.ADME-ToxicologyADME-toxicology (ADME-Tox) studies are used in pharmacology and pharmacokinetics to assess the activity/toxicity of drugs <i>in vivo</i> or <i>in vitro</i>. Find bioassays for absorption, distribution, metabolism, and excretion of drug molecules including cytotoxicity, transporter/permeability, metabolism and activity assays as well as hepatocytes and cell lines for ADME. Find the best ADME-toxicology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Animal ModelsThe use of non-human animals in experiments or behavorial observations. The research is conducted inside universities, medical schools, pharmaceutical companies, farms, defence establishments, and commercial facilities that provide animal-testing services to industry. It includes pure research such as genetics, developmental biology, behavioral studies, as well as applied research such as pharmaceutical testing in pre-clinical, before human, studies. Development SoftwareComputational techniques used in both the chemistry and biology aspects of drug development, for data acquisition, data analysis, processing and storage. Software is used for analysis of ADME results, toxicology, clinical trials and regulatory processes. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Cell TherapyCell therapy involves using living cells to treat diseases, often by replacing damaged cells or stimulating regeneration. Stem cell therapy and CAR-T cell therapy are examples of cutting-edge treatments in regenerative medicine and cancer immunotherapy. Browse our peer-reviewed product directory to find the best cell therapy tools, compare products, check reviews, and get pricing directly from manufacturers.BiotherapeuticsBiotherapeutics are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or in <i>in vivo</i> diagnostics. The most well-known example of a biotherapeutic product, and the first to be approved for therapeutic use, was recombinant human insulin.Animal ModelsDrug DevelopmentDrug development refers to the process of bringing a new drug to market.

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