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| home > ict > Autumn 2012 |
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 PUBLICATIONS |
International Clinical Trials |
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Pharmacovigilance
Safety Signals
Peter B Bottini at Norwich Clinical
Services delves into the world of pharmacovigilance and argues that it
is crucial for responsible organisations to actively engage in the
process in order to reduce safety issues. |
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Mega-Trials
Big Shot
Mega-trials require specialised knowledge in terms
of regulatory compliance. Hans-Peter Guler and Kelly Henkel at INC
Research outline what this knowledge entails and how best to adhere to
the rules, as well as successfully manage the economic pitfalls of a
trial. |
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Cross-Border Clinical Trials
Border Control
John Blakeley at Greenphire
explores how the new European Commission proposals strive to make Europe
a more appealing region in which to carry out clinical trials, and
considers why there is a general feeling that the pharmaceutical
industry should aim to cut trial administration costs. |
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Multi-Site Trials
The Clinical Trial Landscape
Automated and scalable
solutions for the management of concomitant medication in global
clinical trials would appear to be the next step for research. Mark Dale at MAC Clinical Research outlines the relevant advantages and
challenges. |
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CNS Disorders
Scene Change
Frederick T Lewis at PRA points to a range of
solutions that may help to alleviate the array of potential challenges
facing global clinical trials for Alzheimer’s disease and multiple
sclerosis. |
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eClinical Systems
The Road Ahead
In the age of digital data, it is necessary for eClinical systems to be
malleable to the ever-changing range of electronics. Bill Cooney at Medpoint outlines the criteria that he believes it will be necessary to
adhere to. |
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Strategic Partnerships
Hidden Gems
Partnerships between CROs and service providers have long been a hot
topic in the pharma world; however, Stephen Plotkin at MDSL
International believes that smaller companies in particular can reap the
benefits from these tactical unions. |
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Poland: Regulatory Compliance
Different Country, Different Rules?
As
central and eastern Europe grows in popularity as a region for
conducting clinical trials, CROs are turning to Poland on a more regular
basis. Bozena Ciosek and Marta Godamska-Gołab at Wierzbowski Eversheds
explain how changes in EU regulations could affect this trend. |
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Ukraine: Regulatory Compliance
Cracking Kiev
With the emergence of
Ukraine in the clinical trials sector, Oksana Maksimova and Tetyana
Demidenko at CTL outline how the legal landscape of the country is being
transformed, and the economic boost that this will facilitate for the
region. |
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Electronic Medical Records
Big Data, Big Results
Simon Beaulah,Robin
Munro and Paul Denny-Gouldson at IDBS argue that big data could hold the
key to improving patient outcomes, but explain that investment will be
required in order to access the full benefit of this technology. |
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Clinical Data Traceability
Store Cupboard
In clinical trials, it is
essential that sponsors are able to accurately locate and retrieve all
the data generated on a product. Michael Whitworth at Quanticate runs
through some of the key challenges that are faced, and why it is
important to overcome them. |
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Adaptive Data
Quest for Quality
Lucia Simoni and Giovanni Fiori at MediData srl outline their ‘five Ws’ concept relating to observational
research, and why they believe that these must be followed when
conducting any observational study.
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Sample Storage
Smart Biobanking
Biobanking is a concept that sparks
controversy. Divyaa Ravishankar at Frost & Sullivan considers
whether it could be a viable option in the long-term, and how researchers
can ensure the integrity and usability of samples. |
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Biomarkers
Forward Planning
As predictive biomarkers take centre stage
in cancer therapies, Jason Yang, Martine Poelman, Rachel Reams, Thomas
Turi and Nasser Azli at Covance take a look at what has prompted this
growing trend and whether or not it can assist drug evaluation and
reduce late stage failures. |
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Book Review:
Playing the Field
Graham Hughes reviews Global Clinical
Trials Playbook – Capacity and Capability Building, edited by Menghis
Bairu and Richard Chin.
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PCT Interview
Tight Connections
Sarah Palit of Informa Life Sciences
opens up to ICT about the upcoming Partnerships in Clinical Trials event
in Hamburg later this month.
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Industry Interview:
Thinking Allowed
Elena Logan of PPD talks to ICT
about her predictions for 2013 and the significance of relationships in
the new contract research landscape. |
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News and Press Releases |
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PCI and CSP Technologies, Inc. Announce Strategic Collaboration for Breakthrough Activ-BlisterTM Solutions
Philadelphia, PA & Auburn, AL – September 17, 2018 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global healthcare industry, is pleased to announce its exclusive collaboration agreement with CSP Technologies, Inc. for U.S. clinical trials and stability testing utilizing Activ-BlisterTM packaging solutions, which help protect and promote speed-to-market for pharmaceutical and medical device products with heightened susceptibility to moisture and gases, especially oxygen.
More info >> |
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White Papers |
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Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials
Perceptive Informatics
Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
More info >> |
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Industry Events |
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CPhI & P-MEC India 2018
12-14 December 2018, India Expo Mart, New Delhi, India
CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part
of Informa PLC) – announces that the 12th edition of Asia’s
largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new
venue will see the exhibition now hosted in a single venue, bringing it closer
to the Indian regulatory and legislative capital. New Delhi is also the
country’s main international transport hub and will encourage an increased
international attendance. In total, more than 50,000 people from 122 countries
are expected, along with nearly 1,500 exhibitors.
More info >> |
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