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| home > ict > Autumn 2017 |
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 PUBLICATIONS |
International Clinical Trials |
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Editor’s Comment
Dr Graham Hughes, Editor of ICT, takes a look at some of the key discussion points of this issue, touching on the Internet of Everything, the development of medical devices and the recently instigated EU directives.
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European Focus
Restricting Regulations
Rules and regulations often slowdown clinical trial practices, affecting the processing time between thelaboratory and the consumer. Craig Morgan at goBalto asks whether there is anyopportunity for change in Europe.
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Mental Health Research
A New Horizon
With mental health often overlooked, Professor Kathryn Abel at NIHR examines new, low-cost methods that could help clinical studies in this particular field.
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Managing Cell and Gene Therapies
Perfect Planning
As the worldwide market for regenerative medicines continues to grow, Lisa Vocat at World Courier talks about the logistical challenges now faced when developing new drugs for this therapeutic area.
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Trials in Pneumonia
Problematic Patterns
The team at PSI CRO discuss how distinguishing trends followed by serious adverse effects is vital when large amounts of new antibiotics are being tested for community acquired pneumonia.
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Unifying Operations
Better Together
Rik Van Mol at Veeva Systems believes the answer to questions surrounding streamlining clinical systems is industry-wide operational continuity.
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Serialisation Beyond Compliance
Keeping Track
Serialisation is an essential factor in maintaining compliance, but Steve Wood at Covectra notes its potential in other areas, such as anti-counterfeiting and delivery to end-users.
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Mobile Services
Closer to Home
The incorporation of mobile units within patient recruitment can improve retention and enrolment rates. Lindsey Copeland and Diane Campbell at CK Aspire discuss the impact this has on clinical trials.
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Translation and Local Knowledge
In Other Words
Gary Muddyman at Conversis analyses the complex undertaking of communicating messages to a global audience, highlighting the importance of tailoring your content and ensuring quality of data.
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Q&A: Adapting to New Regulations
Hindering Hazards
Patrick Hughes at CluePoints explains the impact of new regulatory updates in trial quality maintenance, specifically covering ICH E6 R2, and how pharma companies can handle this shift.
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IoE in Clinical Trails
Superior Strategy
CRF Health’s Richard Strobridge reflects on how the Internet of Everything could positively impact healthcare in terms of improved patient experience and focus within clinical trials.
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Wearable Technology
Fastening Pharmaceuticals
Jeremy Wheeler at Quanticate reviews the noticeable benefits that incorporating wearable medical devices may have or pharma companies trying to bring new medicines to the market.
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New Developments in Patient Outcomes
Technological Takeover
IBM Watson Health’s Jeff Beeler and Alysa Lesemann consider how patient-reported outcomes, alongside new technological reporting methods, can provide guidance
when developing new drugs.
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Compliant Packaging
Handle with Care
The shipping of biological substances across borders needs to be rigorously regulated, so Sue Fletcher at Alpha Laboratories Ltd discusses the importance of complying with UN3373.
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End Point
A Costly Cause
Looking to the future of clinical trials, ICT editor Dr Graham Hughes emphasises the worrisome impact of the expensive development of precision medicines.
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News and Press Releases |
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Arcis Biotechnology appointments Professor Steve Howell as Non-Executive Chairman
Daresbury, UK, 24 July 2019: Arcis Biotechnology (“Arcis”), the nucleic acid sample preparation solution provider, today announced it has appointed Professor Steve Howell as Non-Executive Chairman of its Board of Directors. Steve takes over the position from Paul Foulger, who was serving as Chairman on an interim basis on behalf of the Board.
More info >> |
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White Papers |
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Key to Outsourcing Method Development and Validation: A Pragmatic Approach
RSSL
In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation.
As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP).
Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
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Industry Events |
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CPhI Festival of Pharma
5-16 October 2020, Virtual
A virtual gathering for the pharmaceutical industry, the CPhI
Festival of Pharma has been created to fill the gap left by in-person events at
a time when travel and gatherings are off the cards.
More info >> |
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