跳至主要内容

WIL IT software deal speed up US FDA drug evaluations? Yes says Instem


Regulatory reviewers spend more time managing incoming data than on the drug evaluation process, says Instem which has inked a deal with WIL Research for its nonclinical IT systems.

Preclinical contract research organisation (CRO) WIL has placed an order with IT technology firm Instem for study-related software systems at all its sites worldwide, expanding on an exclusive nonclinical partnership deal struck back in May.
Among the systems WIL has purchased is Instem’s Submit software, used to support the Standard for Exchange of Nonclinical Data (SEND) which is being adopted by the US Food and Drug Administration (FDA) to speed up the development process by providing a vehicle for easier transportation of results of regulatory toxicology studies to regulators.
“FDA reviewers continue to receive mostly paper or electronic paper (PDF) submissions as they evaluate new applications for drugs,” Julie Jones a spokesperson from Instem told Outsourcing-Pharma.com. “They are then manually entering data for further analysis, which is time consuming and inefficient, taking time away from the primary mission of reviewing the content of submissions.”
“Reviewers are actually spending more time manipulating the incoming data than they are on the actual drug evaluation process.”
WIL has also signed up to use Instem’s Provantis trial monitoring tool that allows its toxicology clients to remotely logon to a secure website to view on-going study data.
“Provantis streamlines processes and workflows with straightforward, intuitive functionality for simple and complex studies within GLP or non-GLP environments,” Jones explained.
David Spaight, CEO at WIL Research said: “I’m confident that our expanded technology investment will enrich our research processes, help develop better controls and provide excellent experiences for every one of our clients, while expanding our capabilities for continued growth.”

标签：

评论

发表评论

此博客中的热门博文

Medicilon and Binhui Biopharmaceutical Have Reached a Strategic Collaboration to Jointly Draw a New Blueprint for the Development of New Biological Drugs

  On March 18, Medicilon and Binhui Biopharmaceutical (Binui Bio) announced a strategic collaboration.  The two parties will work together to jointly explore the possibilities in cutting-edge fields such as oncolytic viruses, nucleic acid drugs and protein drugs. Gather and Work Together to Create Advantages      Facilitate the Research and Development of Oncolytic Viruses, Nucleic Acids, Proteins and Other Drugs As a one-stop biopharmaceutical comprehensive preclinical R&D service CRO, Medicilon has been developing and accumulating for 20 years, always adhering to the spirit of innovation, and has successfully constructed bi/multi-specific antibodies,  ADCs ,  mRNA vaccines ,  small nucleic acid drugs ,  PROTAC , and  CGT technical service platform  that have helped 421 INDs obtain clinical approval.  It is this outstanding achievement that has earned Medicilon wide recognition in the industry and laid a solid foundation f...
发表评论
阅读全文

A Nickel-Catalyzed Reductive Alkylation of Aryl Bromides and Chlorides for Sp3-Sp2 Bond Formation

  In 2012, a nickel-catalyzed reductive alkylation method of aryl bromides and chlorides was reported. Under the optimized conditions, a variety of aryl and vinyl bromides as well as active aryl chloride can be reductively coupled with alkyl bromides in high yields. The protocols were highly functional-group tolerant and the reactions were not air or moisture sensitive. The reaction showed different chemoselectivity than conventional cross-coupling reactions. Substrates bearing both anelectrophilic and nucleophilic carbon resulted in selective coupling at the electrophilic carbon (R-X) and no reaction occurred at the nucleophilic carbon (R-[M]). The 2010 Nobel Prize in Chemistry was awarded for the Pd-catalyzed cross-coupling, and in the past decade the progress in cross-coupling has not only had a significant impact on academic research but has also influenced the industrial synthetic application. The transition-metal-catalyzed union of nucleophilic organo-boronic acids with elect...
发表评论
阅读全文

What is Toxicokinetics?

Toxicokinetics  is essentially the study of “how a substance gets into the body and what happens to it in the body”. Four processes are involved in toxicokinetics. The study of the kinetics (movement) of chemicals was originally conducted with pharmaceuticals and thus the term pharmacokinetics became commonly used. In addition, toxicology studies were initially conducted with drugs. However, the science of toxicology has evolved to include environmental and occupational chemicals as well as drugs. Toxicokinetics is thus the appropriate term for the study of the kinetics of all toxic substances. Frequently the terms  toxicokinetics ,  pharmacokinetics , or disposition may be found in the literature to have the same meaning. Disposition is often used in place of toxicokinetics to describe the time-course of movement of chemicals through the body (that is, how does the body dispose of a xenobiotic?). The disposition of a toxicant along with its’ biological reactivi...
发表评论
阅读全文