Why should you use clinical trial technology?
New, innovative clinical trial technology is helping to revolutionize the research landscape.
Regulatory affairs
ReciBioPharm - An optimized Plasmid DNA platform to accelerate the path to clinic and commercialization
Assessing key parameters of the upstream process to achieve high titer while maintaining desired integrity Customizing the downstream process to address the different needs from supercoil plasmid and linear isoform A platform approach with integrated...
Small Molecule development – getting it right
Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can be fraught with risk.
A Guide Through the API Drug Development Pipeline
With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles addressing the many challenges for biotechs, this eBook is your guide to navigating the drug development...
The Complete Guide to eRegulatory and eSource
Shifting to eRegulatory and eSource workflows is a requirement for clinical trial sites to continue to scale and grow their studies. This guide is designed as an in-depth overview of how eRegulatory and eSource are impacting Clinical Trials, and the...
Using SDTM, ADaM, and SEND
This article gives an overview of SDTM, ADaM, SEND and ARM, and discusses how these CDISC standards fit in with the wider clinical trial process, and how companies in the pharmaceutical industry can get maximum benefit from them.
How clinical trial software can optimize trials
Companies often have to conduct multiple clinical trials at the same time, which means they've got to be efficient, and compliant with industry regulations. They need to be able to see and manage their clinical trials effectively so they can improve...
Strategic Approach to Immunogenicity Assessment
In this issue of The Altascientist we provide a detailed overview on the different goals and challenges that are presented by the validation of immunogenicity assays to support nonclinical and clinical studies, including a case study.
Psychedelics and Entactogens: Challenges Associated with Schedule I Therapeutic Development
Under the Controlled Substances Act (CSA) in the United States, drugs that have the potential to be abused are scheduled into one of five Classes or Schedules (CI-V) as controlled substances. The scheduling method makes a distinction for drugs that have...
Clear Guidelines for IND/CTA
There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials.
Automating clinical trials for success
This article gives gives a brief overview of why automation is absolutely essential for clinical trial success.
Empowering Clinical Trial Sponsors with Analytics
Is your Clinical Data Review creating problems or solving them? Take Control of Your Data. PerkinElmer Informatics Clinical Solutions, powered by Tibco Spotfire, are the most efficient, scalable, and centralized offerings for clinical data analysis.
Global Pediatric Drug Development Collaboration: Part One
The pharmaceutical industry is unlike any other industry in that the products manufactured can dramatically improve, and even save, lives. This is especially the case when it comes to children. Although pediatric patients comprise a smaller population of...
Global Pediatric Drug Development Collaboration: Part Two
70% of medicines given to children have never been studied in pediatric populations. Children who need treatments represent a relatively small population. This alone presents unique challenges for pediatric drug development. Since the 1990s, authorities...
Outsourcing Analytical Testing for Biologics - A CRO's Perspective
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...
How to Avoid Surprises in Small-Molecule Drug Development Programs
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...
Validating The Simoa Technology
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...
The Truth about Physician Referrals and Clinical Trials
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...
Survey Report: State of the global pharmaceutical contract services industry 2018
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,...
Elemental Impurities Regulations View from a CRO
Regulatory control of elemental impurities in pharmaceutical products has long been discussed, with both the European Pharmacopeia (EP) and the United States Pharmacopeia (USP) having planned on...
The whole blood assay: Detection of broad spectrum of pyrogens & examples of medical device testing
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...