Irena Maragkou

London

Senior Researcher at GlobalData

Senior Researcher at Pharmaceutical-Technology.com

Senior Researcher at Clinical Trials Arena

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Articles

Patient centricity and effective designs drive clinical trial success

1 week ago | finance.yahoo.com | Irena Maragkou

The aim of the EU Clinical Trials Regulation (CTR) is to harmonise the clinical trial regulation process across 27 countries and have an 80-day approval timeline, stated Dr. Martine Dehlinger-Kremer, vice president of Scientific Affairs at global contract research organisation (CRO) ICON.
Patient centricity and effective designs drive clinical trial success

1 week ago | clinicaltrialsarena.com | Irena Maragkou

The aim of the EU Clinical Trials Regulation (CTR) is to harmonise the clinical trial regulation process across 27 countries and have an 80-day approval timeline, stated Dr. Martine Dehlinger-Kremer, vice president of Scientific Affairs at global contract research organisation (CRO) ICON.
Putting patients and sites first is key to a seamless clinical trial transition

1 week ago | clinicaltrialsarena.com | Irena Maragkou

Sometimes trials can go off track and need rescuing, but that does not always have to mean a rescue from another CRO, says Suzanne McNally, Executive Director in Portfolio Management at contract research organisation (CRO) Parexel. While elaborating on the concept of ‘rescue’, she said: “It can also mean a transfer from one sponsor to another, or in the event of an asset purchase when one asset needs to be moved from one sponsor to another,” in addition to vendor transfers.
OCT Europe: Small and mid-sized sponsors demand smart and reliable partnerships

2 weeks ago | clinicaltrialsarena.com | Irena Maragkou

One of the key challenges in clinical trial operations today is maintaining a trustworthy and reliable relationship with partners, vendors, and sites, says Sarah Bischof, Head of Clinical Developments at invIOs, a private biotech company developing next-generation cancer therapies.
Charting success through uncertainty in AI clinical trial implementation

2 weeks ago | clinicaltrialsarena.com | Irena Maragkou

Artificial Intelligence (AI) can augment productivity in clinical trial delivery and more, says Piotr Maslak, Director of Operational Data Intelligence at AstraZeneca. Maslak was speaking on the first day of the 15th Annual Outsourcing in Clinical Trials Europe conference, where he delved into ways to implement AI in clinical trials, and then measure success, using practical examples.
Redefining the future of clinical trials in oncology

3 weeks ago | clinicaltrialsarena.com | Irena Maragkou

Next month, experts from big and small pharmaceutical and biotech companies, contract research organisations (CROs), cancer counselling and resource centers as well as biobanks will discuss the current trends and strategies for clinical trial success in oncology at the 12th Annual Clinical Trials in Oncology meeting in Burlingame, California.
Shaping the future of clinical trials in the EU

1 month ago | clinicaltrialsarena.com | Irena Maragkou

Later this month, experts from healthcare companies, contract research organisations (CROs), and patient advocacy groups will gather to do a deep-dive into current trends and innovations in clinical trial operations at the Outsourcing in Clinical Trials (OCT) Europe meeting in Barcelona, Spain. Industry experts will gather at the 15th Annual OCT Europe meeting, to discuss not just the challenges in the clinical trial industry, but also patient perspectives and technology advancements.
IRA holds the scope to shape pharma’s research strategy

1 month ago | pharmaceutical-technology.com | Irena Maragkou

Skip to site menuSkip to page content Pharma companies will need to rethink business and research and development (R&D) strategies to mitigate against the global impact that will be felt from the US Government’s Inflation Reduction Act (IRA), experts have said. “The US has a dominant effect across the world, so IRA provisions will have a global effect,” said Mel Walker, CEO of strategic advisory company Access InVivo.
European agencies catch up with speedier regulatory pathways for CGTs in the US

1 month ago | businessandamerica.com | Irena Maragkou

Although the regulatory landscape for advanced therapy medicinal products (ATMPs) is rapidly evolving, varying regulatory requirements across different regions are hindering cell and gene therapy (CGT) adoption.
European agencies catch up with speedier regulatory pathways for CGTs in the US

1 month ago | pharmaceutical-technology.com | Irena Maragkou

Shorter trial authorisation timelines for ATMP trials in the US are an advantage for biotechs, say experts. DNA Helix. Credit: koto_feja via Getty Images Although the regulatory landscape for advanced therapy medicinal products (ATMPs) is rapidly evolving, varying regulatory requirements across different regions are hindering cell and gene therapy (CGT) adoption.