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International Clinical Trials

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Spring 2021

   
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Features
Unlocking the Potential of CAR T Therapy

Mircea Cubillos at Janssen

Why acting on patient perspectives early is key to transforming the blood cancer treatment landscape
 
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The Optimisation of Clinical Quality Management Systems

ICT interviews Steve Whittaker at WCG Avoca, who describes how the evolving regulatory landscape of the clinical trial industry stands to spur change in the way we manage data
 
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Lean Medical Writing: Story Not Storage

Barry Drees at Trilogy Writing & Consulting

Functional language is paramount in clinical writing. An abundance of data, figures, and complicated wording makes concise and comprehensive clinical study reports close to impossible
 
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The Biotech Journey: From Lab Development to Clinical Delivery

Erin Finot at IQVIA Biotech

With COVID-19 fuelling the modernisation of clinical trials, coupled with increased investment in the biotech and emerging biopharma sector, the competition to get new therapeutics to market quickly is intensifying at a rapid rate
 
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Role of Biosimilars in Clinical Trial Supplies

Vanessa Dekou at Clinical Services International

Biosimilar products offer a robust and cost-effective solution for clinical trial supplies. There are, however, important considerations to be addressed at protocol design level
 
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Biopharma Sector Stands Ready to Meet Demand for Innovation

Ahmed Bouzidi at ProductLife Group

The biopharmaceutical industry, in particular innovative SMEs and mid-sized companies, has been centre stage in tackling COVID-19. Yet, small and mid-sized biopharma companies face a complex global environment when it comes to funding and regulatory incentives
 
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Inclusive Cultures and Innovative Outputs

In the past year of disruption across the globe, we have never been more aware of diversity. Stephen Frost and Nick Basannavar at Included discuss how pharma can action these insights to create inclusive workspaces
 
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Medical Cannabis in Europe – An Opportunity Ripe for Exploitation

Peter Kohut at Arriello

Medical cannabis has proven efficacy, yet it does not benefit from a consistent regulatory framework across Europe. As a result, this is a challenging market. However, the rewards are there for the taking for pharma businesses that can navigate the complexity
 
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Modern Data Challenges
Clinical Trials in 3D – Decentralised, Data Science, and Digital Transformation

Temitope Keyes at Cmed Technology

The pandemic has forced much of the world to pivot to remote working practices over the last year, and clinical trials are no exception – site-based trials have many limitations, several of which can be addressed by implementing technology to support a new, patient-centric model for healthcare
 
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Data Literacy: Modernising Clinical Trial Execution

Kristin Mauri at Remarque Systems

Technology has outpaced companies' ability to interpret results, so they tend to shy away from data-driven, risk-based approaches. Data literacy translates into critical thinking, driving actionable analyses
 
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The Importance of Data Management in Clinical Trials

Denise Milovan and Cara White at Altasciences

Providing regulators with reliable, quality data requires planning and specialised skills, which can sometimes be more easily outsourced to a qualified vendor
 
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Accelerating Towards Modern Clinical Trials

Rik Van Mol at Veeva Systems

Modernising clinical trials with digital solutions can improve the patient journey, accelerate clinical research, and alleviate patient burden with virtual and remote solutions
 
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A Patient-Centric Approach to Clinical Trials

Carolina Rossi Wosiack at CI&T

With the changing world driving innovation in clinical trials, patients require better, more convenient trial designs to work into their daily lives. Decentralised or hybrid trials could provide the solution
 
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Ensuring Data Integrity with ePRO Methods

Sachin Bharadia at CRO PHASTAR

The pandemic has shown the clinical trial industry that the true value of digital solutions go beyond cost savings, and can also increase data integrity
 
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The Resilience of Real-World Data

Paul O’Donohoe at Medidata

Real-world data from digital technologies are key in future-proofing clinical trials. From the widespread usage of wearable technologies to new digital innovations, clinical trials are beginning to benefit from the application of recorded patient data
 
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Adding Intelligence to Integration

Romuald Braun at Amplexor

Regulatory information management is increasingly data-dependent. Many life science companies have made good progress towards integrating systems that contain regulatory data, enabling information to be exchanged between them
 
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Translation and Local Knowledge
The Pillars of Centralisation

Dan Koenig at Argos Multilingual
 
In a world of increasing compliance demands and shrinking budgets, a centralised content strategy can be vital in accelerating time to market while increasing quality and cost savings
 
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Three Challenges in Creating Plain Language Summaries of Clinical Trial Results

Wendy Farrell at RWS Life Sciences

COVID-19 brought with it a heightened focus on scientifically validated evidence to combat public distrust and misinformation, and pharma companies around the world are now coming together to increase transparency and improve education surrounding clinical trial results
 
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Phase IV Trials
Top 10 Considerations When Working With RWE

Jeff Trotter at Worldwide Clinical Trials

Real-world data doesn’t have to seem out of this world. To grasp the valuable insights it  offers, research teams should not underestimate its importance to regulators and other stakeholders
 
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Driving Industry Impetus

The clinical trial industry has been rocked by the pandemic, but that hasn’t meant that innovation has stalled. Tom Nichols at PIPA discusses trends in the industry, and the growing focus on pharmacovigilance
 
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Leading Non-Interventional Post- Authorisation Safety Studies to Success

Lars Behrend and Michael Sigmund at SSS International Clinical Research

In post-authorisation safety studies you need high data quality and compliance to fulfil requirements of regulatory authorities. Particularly with local doctors, which have limited infrastructure, such studies have a special challenge to keep timelines and match compliance criteria
 
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