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| home > white papers > Overcoming research challenges with Adaptive Trials - PCI Pharma Services |
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 WHITE PAPERS |
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PCI Pharma Services
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Overcoming research challenges with Adaptive Trials
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There has been cause for concern within the pharmaceutical industry over
the last five years, regarding increasing research and development
costs, combined with a fall in the number of new drugs brought to
market. In an attempt to overcome this issue there has been a
significant rise in the use of adaptive clinical trial designs, whilst
saving time and money as well as facilitating more effective decision
making. One of the biggest challenges that pharmaceutical companies have
experienced has been delivering compliant clinical trials supplies
across diverse patient populations in the relatively short timeframes
that adaptive trial designs require, remaining focused on ensuring that
patient compliance and product quality is in no way compromised. This
demand has led to the launch of fast response services that support
Research and Development in responding to changing dosing regimens
mid-trial.
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News and Press Releases |
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Introducing Signant Health [Formerly CRF Bracket] and the Industry’s Most Comprehensive Patient-Centric Suite for Clinical Research
Philadelphia and London – June 10, 2019: CRF Bracket, formed by the 2018
merger of CRF Health and Bracket, today launched as Signant Health
(signanthealth.com). Uniting eCOA, eConsent, Patient Engagement, IRT,
Clinical Supplies and Endpoint Quality into the industry’s most
comprehensive patient-centric suite, Signant makes it easier to
participate in – and sites and study teams to run – clinical trials.
This intense focus on the patient experience, deep therapeutic area
expertise and global operational scale enable sponsors and CROs to
extend the reach of drug development, expand patient opportunities and
improve data quality.
More info >> |
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White Papers |
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The BioPharmaSpec Approach”: Mass Spectrometry Based Host Cell Protein Identification and Quantitation
BioPharmaSpec
1. Introduction
As part of the development of any biopharmaceutical product, the impurities present must be examined, minimized and where possible characterized (1). These impurities fall into two broad categories: product-related impurities (derived specifically from the drug product itself) and process-related impurities (derived from material associated with the production, processing or purification of the sample). Host cell proteins (HCPs) are process-related impurities that require specific analysis due to the multitude of naturally occurring proteins expressed in the production cell line.
More info >> |
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Industry Events |
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Nordic Life Science Days 10/12 September 2019
10-12 September 2019, Malmo Sweden
Nordic Life Science Days is the largest Nordic partnering conference for the global Life
Science industry.
Bringing together the best talents in Life Science, offering amazing networking and
partnering opportunities, providing inputs and content on the most recent trends.
Nordic Life Science Days attracts leading decision makers from the Life Science sector,
not only from biotech, pharma and medtech but also from finances, research, policy and
regulatory authorities.
More info >> |
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