Following the rebrand and restructure of the Chinese regulatory body, the China Food and Drug Administration (CFDA), in 2013, the regulation process now includes inspections for all multi-national and local pharmaceutical companies with drug filings in China.
As a continued commitment to meet clients’ needs and conform to local Chinese regulations, the Covance Central Laboratory Services Shanghai team (Covance CLS Shanghai) provides guidance to our clients to navigate CFDA inspections. Backed by more than 10 years of experience in China, the Covance CLS Shanghai team delivers a deeper understanding of CFDA regulatory and operational requirements and helps clients with a standardized process and corresponding documentation.
Today’s clinical trials have become more complex and expensive, pressuring pharmaceutical companies to further improve their clinical trial operations. Clinical trial data management is one area where both sponsors and contract research organizations (CROs) can uncover new efficiencies, increase cost-saving measures and better meet diverse operational reporting needs across the clinical development cycle.
In this blog we begin to examine the current issues with traditional electronic data capture systems and other current “big data” approaches that attempt to address complex operational reporting needs in this historically stagnant and underserved area. We also discuss the use of two distinct data repositories – an operational data warehouse and a clinical data warehouse – the Xcellerate® Clinical Data Hub as part of a new data model through the Xcellerate Informatics Suite to provide a significant technological advance in clinical trial operations. Continue reading →
No single blood test or physical finding alone can confirm the diagnosis of rheumatoid arthritis (RA). However, two tests that detect markers of inflammation are often ordered when RA is suspected: erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Other common tests include rheumatoid factor and anti-CCP antibodies.
RA patients in the United States
While the test results are clearly valuable to the requesting physician to inform diagnostic decisions, sponsors can also leverage this information to support patient recruitment in an increasingly competitive space. We recently evaluated how de-identified patient data from these common tests run by LabCorp can support sponsors’ clinical trials in rheumatoid arthritis. Continue reading →
When it comes to novel drug discovery and development, flow cytometry is known for being both a powerful and versatile technology. It can deliver valuable information to advance early biomarker development, tolerability, clinical studies and even companion diagnostics. But leveraging flow cytometry technologies to answer analytical questions and empower decision making from the research lab to the clinic requires a deep knowledge of cutting-edge approaches.
Virginia Litwin, PhD, principal scientist, hematology/flow cytometry at Covance and her team are examining current trends in rare event analyses assays to ensure that performance is well characterized and fit-for-purpose – particularly in regulated environments. They are also addressing the various hurdles associated with analyzing cellular biomarkers for immunotherapy and adoptive cell therapy. Continue reading →
Providing integrated services to the global biotech and pharma industry
Covance and Arcinova recently expanded a strategic relationship following the signing of a sales services agreement at the end of 2016. Under the terms of the agreement, Covance is offering Arcinova services alongside its own extensive range of drug development capabilities.
Arcinova is a contract research and development organization based in Alnwick, UK. The Company provides small molecule drug substance, product and analytical support from preclinical through to Phase II. Since its inception in February 2016, Arcinova has built on the legacy customer base developed when it was a Covance site, and is now serving biotechnology and pharmaceutical companies on four continents. Continue reading →
Jonathan Zung, Group President, Clinical Development & Commercialization Services, has only been at Covance for a short time, but he already has big plans for the future of our clinical and commercialization businesses, as well as fresh ideas on talent development.
We recently spoke with him to learn more about his passion for operational excellence, and ideas for helping us develop and nurture our own careers. Continue reading →
Biosimilars have dominated the headlines in the U.S. with several FDA approvals, legal battles and questions around reimbursement, placing an increased focus on how to successfully navigate this relatively new pathway from end to end.
Starting with the regulatory environment to CMC bioanalytics and pharmacodynamics, learn how drug developers can understand regulatory differences and identify a fit-for-purpose program. We will also cover how to proactively identify key issues for both PK equivalence and Phase III equivalence studies, and initiate market access and commercialization approaches. Continue reading →
Unlock opportunities for your clinical research programs and deliver results that matter.
We’re excited to be on the cutting edge of drug development solutions. Take a look at our recent webinar topics and leverage our experience.
Going Virtual: Evolving Real World Evidence Study Design for Speed, Flexibility and Lower Cost
Using a traditional clinical-site recruitment approach is no longer the only option in observational research. With the increased adoption of electronic informed consent methods by the FDA, it is now feasible to conduct real world evidence (RWE) studies using a virtual model that eliminates entirely the need for clinical sites.
Join us to learn how to lower cost and improve the efficacy of current, site-based RWE studies as well as:
The implications of electronic informed consent by the FDA
What is required to conduct a prospective virtual RWE study
How to use electronic data for a retrospective virtual RWE study
Covance is excited to announce that Xcellerate® Medical Review has been named a finalist in the Clinical & Research Excellence (CARE) Awards. As a finalist in the Best Sponsor-Focused Technological Developmentcategory, Xcellerate Medical Review is being recognized for its modern approach to improving the clinical trial process. The CARE Awards recognize excellence across the global clinical research enterprise.
The Xcellerate Medical Review informatics product provides a critical function to study sponsors to safeguard subject safety, increase the robustness and quality of clinical trial execution, improve the reliability of investigational data and ensure adherence to ethical standards. Xcellerate Medical Review is a part of the larger award-winning Xcellerate Clinical Trial Optimization® suite, a comprehensive informatics solution that can meaningfully reduce the cost, time, complexity and risk of drug development. Continue reading →
As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents? Continue reading →