News & Analysis on Clinical Trial Services & Contract Research And Development
Solid phase peptide synthesis (SPPS) is generally the method of choice for the chemical synthesis of peptides, allowing routine synthesis of virtually any type of peptide sequence, including complex or cyclic peptide products. In large‐scale peptide...
the exponential growth of data points flowing into clinical study databases. As technologies help researchers to reach more patients all over the world, the amount of data that requires monitoring, formatting, and analysis will only increase over time.
Solvents are defined as organic chemicals that are used to dissolve components. They are used during the manufacture of drug substances and can also potentially be formed as by-products of the synthetic process
Streamline your adoptive cell therapy program with digital PCR. Our team has a unique expertise in digital and quantitative PCR to support you in ensuring your adoptive cell therapy (ACT) meets safety regulations relating to VCN and RCL/RCR levels, even...
At CellCarta, we’re dedicated to working with our partners to further the limitless potential of precision medicine. Our broad technology offering is designed to address specific therapeutic development requirements and provide the most highly customized...
The manufacture of a drug product for clinical trials is of critical importance. The formulation, manufacturing, and assessment of a drug candidate during first-in-human (FIH) trials can be contributing factors in whether the drug safely provides the...
Indena’s Custom Development & Manufacturing Organization services offers a full range of manufacturing capabilities for pharmaceutical ingredients. Such services include the extraction, isolation and purification of natural derivatives and the process R&D...
At Novartis, TIBCO Spotfire® enterprise analytics is a key tool for interactive graphical data analysis for preclinical and clinical studies. Using interactive graphical data exploration provides an efficient, powerful, and flexible tool to improve...
The clinical development process for central nervous system diseases is scientifically and medically complex.
Oncology clinical trials present a unique set of challenges for patients, study sites, and study sponsors. Using electronic patient reported outcomes (ePRO) in conjunction with agile methodology enables nimble, efficient clinical data management...
Immune monitoring has become an essential strategy for understanding, predicting, and monitoring the response of the immune system to therapeutic interventions.
In just a few decades, clinical trials have changed dramatically. Twenty years ago, most of the data used in clinical research was entered on paper, but today it can come from sources as varied as sensors, smartphones, and electronic health records...
Telstar case study. What is the impact of leading-edge innovative developments on the process analytical technology field for pharmaceutical systems and aseptic manufacturing processes? Discover how PAT Tools can easily help in the daily pharmaceutical...
Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed, proteins, given their chemistry, are the “most structurally complex and functionally sophisticated...
Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent of Phase III studies failed due to safety (compared to 55 percent for efficacy), down from 21...
Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used in bioanalysis—such as Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), and...
Despite growing evidence, the myth that physicians won’t refer patients to clinical trials persists, perpetuated by the belief that they fear losing their patients to the investigator. BBK Worldwide’s Study Voices survey challenges the myth, invoking a...
Stability testing is, in essence, a quality control process and is there¬fore a vital component of every phase of clinical development for both large and small molecules – from early phase through to and including post approval. It should be treated as...
In May 2018 Outsourcing-Pharma.com, in association with InnovoCommerce, conducted its second annual ‘state of the industry’ survey on its user base of pharmaceutical professionals, including sponsor companies as well as contract research, development,...
In May 2017, Outsourcing-Pharma.com conducted its inaugural “state of the industry” survey of its user base of pharmaceutical industry professionals, including sponsor companies and contract...
The data used to determine the success of a cleaning validation is built upon both the effective evaluation of the manufacturing plant and the robustness of the validated analytical method. In...
Billions of patients worldwide benefit from a diverse range of medical devices. The global medical device market in 2011 was approximately $300 billion and is predicted to grow by 4% per year to...
Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies...